TABLET FORMULATION FOR PARASTHESIA AND PROCESS FOR PREPARING THE SAME

Abstract

Disclosed here an ayurvedic tablet formulation for neurological health comprising 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, 50-600 gm of Inula racemosa and 10-150 gm of Ferula foetida and process for preparing the same.

Specification

Description:TABLET FORMULATION FOR PARASTHESIA AND PROCESS FOR PREPARING THE SAME

Field of the Invention
In general, the present invention relates to an ayurvedic formulation. More particularly, the present invention provides a fixed-composition tablet formulation for managing tingling sensation along with numbness and process for preparing the same.

Background of the Invention
Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the present invention, or that any publication specifically or implicitly referenced is prior art.
Paraesthesia describes abnormal skin sensations such as tingling, prickling, numbness, or the sensation of "pins and needles." Although it can affect any part of the body, it is most frequently felt in the hands, feet, arms, and legs. These sensations are often temporary and harmless, like when a limb "falls asleep" due to nerve compression. However, in some cases, paraesthesia may become persistent, signalling an underlying health issue.
Despite advancements in modern medicine, there remains a significant need for alternative and more effective treatments for neurological symptoms like tingling and numbness. Conventional treatments often rely on medications such as anticonvulsants, pain relievers, or antidepressants, which may offer temporary relief but are associated with considerable side effects when used long-term. Moreover, these treatments typically focus on alleviating the symptoms rather than addressing the root cause.
Since paresthesia can arise from various underlying conditions, such as nerve damage and vascular deficiencies, making it a significant challenge to develop treatment approaches that address the root cause. Millions of people worldwide suffer from tingling, numbness, and nerve pain, yet options for effective, long-term relief remain limited. The complexity of these conditions highlights the need for solutions that go beyond symptom management and target the underlying issues.

According to Patent No. US20180271838, a pharmaceutical composition is described for the treatment and/or prevention of peripheral neuropathy or spinal cord injury. This formulation contains zonisamide or its alkali metal salt as the active ingredient. While zonisamide may offer temporary symptomatic relief, it is associated with several known side effects, including dizziness, fatigue, and confusion, among others. Additionally, being a chemical-based formulation, it primarily targets symptom management rather than addressing the underlying cause, often leading to the risk of multiple side effects.

According to Patent No. US20210379018, a pharmaceutical composition is described for the treatment of diabetic peripheral neuropathy or chemotherapy-induced peripheral neuropathy. This formulation contains a carbamate compound as the active ingredient. While it offers a targeted approach for these specific conditions, it comes with the potential for side effects. Additionally, this invention focuses narrowly on treating these particular neuropathies and does not provide a more holistic solution aimed at overall nerve health, improved circulation, or support for mental well-being, all without the risk of side effects.

According to Patent No. WO2017106714, the invention describes a method for treating, alleviating, preventing, or reducing symptoms associated with peripheral neuropathies (e.g., neuropathic pain) or sunburn by topically administering a therapeutically effective amount of a pharmaceutically safe agent directly to the affected area. While this approach may help manage symptoms, it lacks a broader, more comprehensive strategy. These treatments focus on symptom relief rather than addressing the underlying causes of conditions like tingling and numbness. Additionally, patients taking multiple medications risk potential drug interactions, which can complicate their treatment plans. Furthermore, the long-term safety of such medications, especially newer ones, remains uncertain, adding another layer of concern to prolonged use.
There is an increasing need for non-invasive, preventative care as more patients seek natural and effective treatments for neurological issues like tingling and numbness. Conventional medical approaches often focus on symptom management and can involve invasive procedures or medications with undesirable side effects.
Despite the well-documented benefits of Ayurvedic herbs like Ashwagandha, known for its neuroprotective properties, natural solutions remain significantly underutilized in mainstream healthcare. This creates a substantial gap that can be addressed by offering well-researched, herbal alternatives that emphasize the therapeutic potential of Ayurveda. By tapping into the underexplored power of natural remedies for neurological health, such solutions could provide patients with a more holistic, sustainable approach to managing their symptoms, offering relief without the side effects commonly associated with conventional treatments.
One of the key barriers to the widespread adoption of Ayurvedic medicine is the lack of standardization and quality control. This highlights the pressing need for an effective, safe, and holistic alternative to conventional treatments for tingling and numbness. Such a solution would address a significant unmet need by targeting the root causes of neurological symptoms, minimizing side effects, and promoting long-term nerve health through a natural, sustainable approach. Standardized and scientifically validated Ayurvedic formulations could provide a reliable and comprehensive treatment option, bridging the gap in current healthcare offerings.

Therefore, there is a pressing need to develop a new and innovative formulation, along with a corresponding method, that effectively addresses the challenges present in existing solutions.

Summary of the Invention
One of the objectives of the present invention is to provide an Ayurvedic tablet formulation which is designed to manage tingling sensations and numbness, addressing several challenges faced in both conventional and Ayurvedic treatments for neurological symptoms.

Another objective of the present invention is to provide an Ayurvedic tablet formulation, wherein this invention aims to enhance patient outcomes by providing a holistic, natural, and scientifically validated alternative to conventional therapies, focusing not only on symptom relief but also on overall nerve health and long-term well-being.

Another objective of the present invention is to provide an Ayurvedic tablet formulation that utilizes natural, plant-based ingredients to treat tingling and numbness (paresthesia), offering a solution that avoids the multiple side effects commonly associated with synthetic drugs such as anticonvulsants and antidepressants.

Another objective of the present invention is to address the underlying vata dosha imbalance, which is considered the root cause of neurological symptoms in ayurveda which focuses on restoring balance to the body's internal systems to promote long-term healing and overall well-being, rather than simply treating the symptoms.

Another objective of the present invention is to formulate an herbal formulation that is standardized and clinically validated for safety and efficacy, ensuring consistency in therapeutic outcomes.


Another objective of the present invention is to develop a formulation addresses existing symptoms along with prevention and progression of nerve damage, thereby promoting preventative care for individuals at risk of developing neuropathy which enhances overall nerve health and reduce the likelihood of future complications by promoting circulation, reducing oxidative stress and allowing regeneration of nerve cells.

Another objective of the present invention is to bridge the gap between traditional Ayurvedic knowledge and modern scientific practices by validating the efficacy of Ayurvedic herbs through rigorous clinical research and advanced testing methods ensuring these treatments are supported by evidence-based science, enhancing their credibility and acceptance in modern healthcare.

Another objective of the present invention is to provide an Ayurvedic tablet formulation, which is easy to administer and offers patient compliance ensuring consistency in treatment and suitability for managing both acute and chronic conditions.

The above and other objectives of the present invention are achieved according to the following embodiments of the present invention. However, the disclosed embodiments are exemplary based on the preferred and best mode of the invention and not limit the scope of the present invention.

In accordance with one preferred embodiment of the present invention, there is provided an ayurvedic tablet formulation for neurological health comprising herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, Inula racemosa and Ferula foetida.

In accordance with one preferred embodiment of the present invention, there is provided an ayurvedic tablet formulation for neurological health comprising 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, 50-600 gm of Inula racemosa and 10-150 gm of Ferula foetida.

In accordance with one preferred embodiment of the present invention, there is provided an ayurvedic, wherein said formulation consists of 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, 100-500 gm of Inula racemosa and 30-100 gm of Ferula foetida.

In accordance with one preferred embodiment of the present invention, there is provided an ayurvedic tablet formulation for neurological health comprising herbal blend of herbs consist of 500-1200 gm of Clerodendrum phlomidis, 500-1200 gm of Gmelina arborea, 500-1200 gm of Aegle marmelos, 500-1200 gm of Oroxylum indicum, 500-1200 gm of Stereospermum suaveolens, 500-1200 gm of Desmodium gangeticum, 500-1200 gm of Uraria picta, 500-1200 gm of Solanum indicum, 500-1200 gm of Solanum xanthocarpum and 500-1200 gm of Tribulus terrestris.

In accordance with one preferred embodiment of the present invention, there is provided a process for preparing an ayurvedic tablet formulation for neurological health comprising adding a herbal blend of coarsely powdered Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestrison in water and heating up to 80 - 100 degrees Celsius for around 7 - 9 hours to achieve decoction, reducing the resultant to 1/16th of its original volume, yielding around 8 litres and filtering and further heating at 50 - 60°C for 2 to 5 hours to achieve a Ghana (thick extract) consistency, while being continuously stirred to prevent burning, adding purified Ferula foetida (Hingu Churna) (powder) and Inula racemosa (Pushkarmoola Churna) (powder) into resultant ghana upon removing from heat and mixing thoroughly, followed by adding 5% starch, 5% dicalcium phosphate, and 5% gum acacia into the resultsant, blending of the Prakshepa Dravya (all adjuvants) with the resultant Ghana employing a wet grinder to ensure the uniformity and placing the resultant blend a tray and drying the same at 50 - 60°C for 4 to 6 hours, formulating the dried resultant by adding 3% talcum powder to ensure smooth tablet formation.

In accordance with one preferred embodiment of the present invention, there is provided a process for preparing an ayurvedic tablet formulation for neurological health comprising adding a herbal blend of coarsely powdered Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestrison in water and heating up to 80 - 100 degrees Celsius for around 7 - 9 hours to achieve decoction, reducing the resultant to 1/16th of its original volume, yielding around 8 litres and filtering and further heating at 50 - 60°C for 2 to 5 hours to achieve a Ghana (thick extract) consistency, while being continuously stirred to prevent burning, adding purified Ferula foetida (Hingu Churna) (powder) and Inula racemosa (Pushkarmoola Churna) (powder) into resultant ghana upon removing from heat and mixing thoroughly, followed by adding 5% starch, 5% dicalcium phosphate, and 5% gum acacia into the resultsant, blending of the Prakshepa Dravya (all adjuvants) with the resultant Ghana employing a wet grinder to ensure the uniformity and placing the resultant blend a tray and drying the same at 50 - 60°C for 4 to 6 hours, formulating the dried resultant by adding 3% talcum powder to ensure smooth tablet formation, wherein the herbal blend used is comprising 5-12 gm of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris.

In accordance with one preferred embodiment of the present invention, there is provided a process for preparing an ayurvedic tablet formulation for neurological health comprising adding a herbal blend of coarsely powdered Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestrison in water and heating up to 80 - 100 degrees Celsius for around 7 - 9 hours to achieve decoction, reducing the resultant to 1/16th of its original volume, yielding around 8 litres and filtering and further heating at 50 - 60°C for 2 to 5 hours to achieve a Ghana (thick extract) consistency, while being continuously stirred to prevent burning, adding purified Ferula foetida (Hingu Churna) (powder) and Inula racemosa (Pushkarmoola Churna) (powder) into resultant ghana upon removing from heat and mixing thoroughly, followed by adding 5% starch, 5% dicalcium phosphate, and 5% gum acacia into the resultsant, blending of the Prakshepa Dravya (all adjuvants) with the resultant Ghana employing a wet grinder to ensure the uniformity and placing the resultant blend a tray and drying the same at 50 - 60°C for 4 to 6 hours, formulating the dried resultant by adding 3% talcum powder to ensure smooth tablet formation, wherein the Inula racemosa used is in quantity of `50-600 gm and Ferula foetida used is in quantity of 10-150 gm.

In accordance with one preferred embodiment of the present invention, there is provided a process for preparing an ayurvedic tablet formulation for neurological health comprising adding a herbal blend of coarsely powdered Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestrison in water and heating up to 80 - 100 degrees Celsius for around 7 - 9 hours to achieve decoction, reducing the resultant to 1/16th of its original volume, yielding around 8 litres and filtering and further heating at 50 - 60°C for 2 to 5 hours to achieve a Ghana (thick extract) consistency, while being continuously stirred to prevent burning, adding purified Ferula foetida (Hingu Churna) (powder) and Inula racemosa (Pushkarmoola Churna) (powder) into resultant ghana upon removing from heat and mixing thoroughly, followed by adding 5% starch, 5% dicalcium phosphate, and 5% gum acacia into the resultsant, blending of the Prakshepa Dravya (all adjuvants) with the resultant Ghana employing a wet grinder to ensure the uniformity and placing the resultant blend a tray and drying the same at 50 - 60°C for 4 to 6 hours, formulating the dried resultant by adding 3% talcum powder to ensure smooth tablet formation, wherein the Inula racemosa used is in quantity of 100-500 gm and Ferula foetida used is in quantity of 30-100 gm.
In accordance with one preferred embodiment of the present invention, there is provided a process for preparing an ayurvedic tablet formulation for neurological health comprising adding a herbal blend of coarsely powdered Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestrison in water and heating up to 80 - 100 degrees Celsius for around 7 - 9 hours to achieve decoction, reducing the resultant to 1/16th of its original volume, yielding around 8 litres and filtering and further heating at 50 - 60°C for 2 to 5 hours to achieve a Ghana (thick extract) consistency, while being continuously stirred to prevent burning, adding purified Ferula foetida (Hingu Churna) (powder) and Inula racemosa (Pushkarmoola Churna) (powder) into resultant ghana upon removing from heat and mixing thoroughly, followed by adding 5% starch, 5% dicalcium phosphate, and 5% gum acacia into the resultsant, blending of the Prakshepa Dravya (all adjuvants) with the resultant Ghana employing a wet grinder to ensure the uniformity and placing the resultant blend a tray and drying the same at 50 - 60°C for 4 to 6 hours, formulating the dried resultant by adding 3% talcum powder to ensure smooth tablet formation, wherein said formulation is prepared by using 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, 100-500 gm of Inula racemosa and 30-100 gm of Ferula foetida.

These and other objectives and embodiments of the invention will become more fully apparent when the following detailed description is read with the accompanying figures and examples. However, both the foregoing summary of the invention and the following detailed description of it represent one potential experiments and embodiment and are not restrictive of the invention or other alternate embodiments of the invention.

Brief Description of The Drawings
Figure 1 is a graphical representation of follow-up wise changes in tingling sensation (Chimchimayana).
Figure 2 is a graphical representation of follow-up wise changes in numbness (Suptata).
Figure 3 is a graphical representation of before and after treatment changes in light touch.
Figure 4 is a graphical representation of before and after treatment changes in pressure touch.
Figure 5 is a graphical representation of before and after treatment changes in pain.
Figure 6 is a graphical representation of before and after treatment changes in temperature.
Figure 7 is a graphical representation of before and after treatment changes in vibration.
Figure 8 is a graphical representation of before and after treatment changes in joint position.

Detail Description of The Invention
The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

Various terms as used herein in the invention is not defined and it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

The present invention is formulation of an herbal tablet formulation, primarily consisting of herbal blend consists of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris), and Pushkarmoola (Inula racemose), and Hingu (Ferula foetida) to develop an effective therapeutic preparation. The invention focuses on optimizing the formulation by varying the concentrations of key components such as herbal blend consists of 10 herbs: Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)], Pushkarmoola (Inula racemose) and Hingu (Ferula foetida). The composition is prepared following a specific method designed to preserve and enhance the therapeutic efficacy of the herbal components. This invention seeks to introduce and protect this unique formulation for its potential in paresthesia.

Herbal blend disclosed herein according to present invention is a combination of ten herbs: Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)] is used as the base for the Ayurvedic tablet known for pacifying Tridosha-shamaka (Vata, Pitta and Kapha). Pushkarmoola (Inula racemose) is potent extract renowned for its benefits in pacifying Vata and Kapha dosha. Hingu (Ferula foetida) is a pungent element which again pacifies Vata, Pitta and Kapha dosha from the body.

Preparing a tablet having fixed based polyherbal composition using Ayurvedic blend including herbal blend ( blend of 10 herbs), Pushkarmoola and Hingu, wherein said formulation is as an Ayurvedic tablet form prepared by adopting a precise method, wherein the formulation is prepared and trials done on participants to evaluate the efficacy of the tablet with fixed composition.

The formulation disclosed according to the present invention is natural and Non-Toxic and provide long-term effect unlike chemical-based treatments that may only provide short-term relief, Ayurvedic treatments help by providing preventive measures by enhancing circulation, reducing oxidative stress, and promoting the regeneration of nerve cells.

The Ayurvedic tablet formulation is formulated using naturally derived ingredients, which are free from synthetic chemicals, sulfates, and parabens and effectively reduces the risk of side effects such as dependency, drowsiness, dizziness, liver or kidney damage, and other long-term damage caused by chemical-based treatments.

Below are the various experiments for preparing different compounds according to the present invention. However, the below examples are not limited and will be further worked on within the scope of the current invention and filed:

Experiments:
Experiments along with their inference

Formulation and component Percent range/concentration range Any specific order/process/steps of preparation Inference of outcome related to specific formulation batch
Formulation 1

Decoction preparation:
Pushkarmoola (Inula racemose)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)

Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


100 gm

5 kg


















5%
5%
5%
3% Decoction of herbal blend is prepared to which Pushkarmoola as an adjuvant is added along with other adjuvants and prepared in a tablet form. Participants experienced no significant improvement.
Formulation 2

Decoction preparation:
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)

Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


100 gm
5 kg


















5%
5%
5%
3% Decoction of herbal blend prepared to which Hingu as an adjuvant is added along with other adjuvants and prepared in a tablet form. Participants experienced no significant improvement.
Formulation 3

Decoction preparation:
Pushkarmoola (Inula racemose)
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)

Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


150 gm

50 gm
4 kg



















5%
5%
5%
3% Decoction of herbal blend is prepared to which Hingu and Pushkarmoola adjuvants are added along with the other adjuvants and prepared in a tablet form. Participants experienced minimal reduction in tingling and numbness.
Formulation 4

Decoction preparation:
Pushkarmoola (Inula racemose)
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)

Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


50 gm

50 gm
8 kg


















5%
5%
5%
3% Decoction of herbal blend is prepared to which Hingu and Pushkarmoola adjuvants are added along with the other adjuvants and prepared in a tablet form. Participants showed no significant improvement in symptoms or nerve function.

Formulation 5

Decoction preparation:
Pushkarmoola (Inula racemose)
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)

Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


150 gm

10 gm
8 kg


















5%
5%
5%
3% Decoction of herbal blend is prepared to which Hingu and Pushkarmoola adjuvants are added along with the other adjuvants and prepared in a tablet form. A slight improvement in symptoms which is not significant.
Formulation 6

Decoction preparation:
Pushkarmoola (Inula racemose)
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)


Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder



150 gm

50 gm
15 kg


















5%
5%
5%
3% Decoction of D herbal blend is prepared to which Hingu and Pushkarmoola adjuvants are added along with the other adjuvants and prepared in a tablet form. Participants experienced gastric discomfort and nausea with no additional therapeutic benefits.
Formulation 7

Decoction preparation:
Pushkarmoola (Inula racemose)
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)


Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


600 gm

50 gm
8 kg



















5%
5%
5%
3% Decoction of herbal blend is prepared to which Hingu and Pushkarmoola adjuvants are added along with the other adjuvants and prepared in a tablet form. Participants exhibited no additional benefits beyond the improvements seen in the optimal range.
Formulation 8

Decoction preparation:
Pushkarmoola (Inula racemose)
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)

Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


150 gm

150 gm
8 kg


















5%
5%
5%
3% Decoction of herbal blend is prepared to which Hingu and Pushkarmoola adjvants added along with the other adjuvants and prepared in a tablet form. The use of excess Hingu caused gastrointestinal distress, acidity, burning sensation in chest and abdomen, burning during micturition and had no added efficacy in treating symptoms.
Formulation 9

Decoction preparation:
Pushkarmoola (Inula racemose)
Hingu (Ferula foetida)
Herbal blend
(Combination of powders of Agnimantha (Clerodendrum phlomidis), Gambhari (Gmelina arborea), Bilva (Aegle marmelos), Shyonaka (Oroxylum indicum), Patala (Stereospermum suaveolens), Shaliparni (Desmodium gangeticum), Prishniparni (Uraria picta), Bruhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Gokshura (Tribulus terrestris)


Tablet Preparation (Other Adjuvants):
Starch
Dicalcium phosphate
Gum Acacia
Talcum powder


100-500 gm

30-100 gm
5-12 kg



















5%
5%
5%
3% Decoction of herbal blend is prepared to which Hingu and Pushkarmoola adjuvants are added along with the other adjuvants and prepared in a tablet form. Experiments are conducted with doses both below and above the recommended range to assess the drug's efficacy. The results demonstrated that the drug's therapeutic potential is significantly diminished when administered outside the specified dosage range, highlighting the importance of adhering to the optimal dosage for effective treatment.


Method of Preparation:
In the preparation of herbal blend Ghanavati, based on a pilot study, 8 kg of herbal blend Churna (coarsely powdered herbal blend) is taken and combined with 128 litres of water,
this mixture is then heated to a temperature of 80 - 100°C for approximately 7 to 9 hours to prepare herbal blend Kwatha (decoction),
the decoction is reduced to 1/16th of its original volume, yielding around 8 litres. It is then filtered and further heated at 50 - 60°C for 2 to 5 hours to achieve a Ghana (thick extract) consistency, while being continuously stirred to prevent burning,
once the desired consistency is reached, the Ghana is removed from heat and 50 gm of purified Hingu Churna (powder) and 150 gm of Pushkarmoola Churna (powder) are added as adjuvants and mixed thoroughly,
following this, the other adjuvants including 5% starch, 5% dicalcium phosphate, and 5% gum acacia are incorporated into the Ghana in adequate quantities,
the mixture is then transferred to a wet grinder to ensure the uniform blending of the Prakshepa Dravya (all adjuvants) with the herbal blend Ghana. The blend is placed in a tray and dried at 50 - 60°C using a tray dryer for 4 to 6 hours,
after proper drying, 3% talcum powder is used as a glidant to ensure smooth tablet formation,
the mixture is then compressed into 500 mg tablets using a 16 STN Single Rotor Punch tablet pressing machine, resulting in the final product, herbal blend Ghanavati,
once prepared, 28 tablets are packed in plastic bags and stored at room temperature in a dry place. Each patient received one packet of 28 tablets on the day of enrollment and another on the 7th day, providing a 14-day course of herbal blend medication for evaluation.
The following tables and graphs present the results of various parameters assessed to evaluate the effectiveness of the optimal formulation, based on studies conducted on human subjects.

Observations based on Changes in Subjective Parameters
Table 1-Changes in Tingling Sensation (Chimchimayana)
Tingling Sensation (Chimchimayana) Day-0 Day-7 Day-14
Number of patients Percentage (%) Number of patients Percentage (%) Number of patients Percentage (%)
No tingling 0 0.00 0 0.00 13 43.33
Not continuous 0 0.00 13 43.33 17 56.67
Continuous but do not disturb routine activity 2 6.67 17 56.67 0 0.00
Continuous but disturb routine activity 28 93.33 0 0.00 0 0.00
Total 30 100.00 30 100.00 30 100.00
The study data reveals the progression of tingling sensation (Chimchimayana) in patients over a 14-day period, with assessments on Days 0, 7, and 14. On Day 0, among 30 patients, 28 (93.33%) experienced continuous tingling that disturbed their daily activities, while 2 (6.67%) reported continuous tingling without interference in their routine. By Day 7, after seven days of medication, 17 (56.67%) patients still had continuous tingling but without disruption to activities, and 13 (43.33%) experienced non-continuous tingling. None reported no tingling or continuous tingling that interfered with activities. By Day 14, 17 (56.67%) patients had non-continuous tingling, while 13 (43.33%) experienced no tingling at all, with no patients reporting continuous tingling. These observations indicate a marked improvement in tingling sensation (Chimchimayana) over the course of the study.
Table-2 Changes in Numbness (Suptata)
Numbness (Suptata) Day-0 Day-7 Day-14
Number of patients Percentage (%) Number of patients Percentage (%) Number of patients Percentage (%)
No numbness 8 26.67 21 70.00 28 93.33
Not continuous 15 50.00 7 23.33 2 6.67
Continuous but do not disturb routine activity 3 10.00 2 6.67 0 0.00
Continuous but disturb routine activity 4 13.33 0 0.00 0 0.00
Total 30 100.00 30 100.00 30 100.00

The data shows significant improvement in numbness (Suptata) over 14 days. Initially, out of 30 patients, 8 (26.67%) had no numbness, 15 (50%) experienced non-continuous numbness, 3 (10%) had continuous numbness without disruption to activities, and 4 (13.33%) suffered from continuous numbness that interfered with daily activities. After 7 days of treatment, 21 patients (70%) reported no numbness, 7 (23.33%) had non-continuous numbness, and only 2 (6.67%) experienced continuous numbness without activity disruption. By Day 14, 28 patients (93.33%) are free of numbness, and only 2 (6.67%) had non-continuous numbness. No patients experienced continuous numbness, indicating a strong trend toward full symptom resolution and the treatment's effectiveness.

Table 3- Observations based on Changes in light touch
Light Touch Before treatment After treatment
Number of patients Percentage (%) Number of patients Percentage (%)
Absent 6 20.00 0 0.00
Altered 24 80.00 15 50.00
Normal 0 0.00 15 50.00
Total 30 100.00 30 100.00

The data on light touch sensation shows a marked improvement after treatment. Initially, 6 patients (20%) had no light touch sensation, and 24 patients (80%) had altered sensation, with none exhibiting normal sensation. Following treatment, no patients had absent sensation, 15 (50%) still had altered sensation, and 15 (50%) achieved normal light touch sensation, indicating significant improvement.
Table 4- Before and After Treatment Changes in Pressure Touch
Pressure Touch Before treatment After treatment
Number of patients Percentage (%) Number of patients Percentage (%)
Absent 0 0.00 0 0.00
Altered 26 86.67 0 0.00
Normal 4 13.33 30 100.00
Total 30 100.00 30 100.00



The data on pressure touch sensation demonstrates the treatment's effectiveness. Before treatment, none of the patients had absent pressure touch sensation, 26 (86.67%) had altered sensation, and 4 (13.33%) exhibited normal sensation. After treatment, all 30 patients (100%) experienced normal pressure touch sensation, with no cases of absent or altered sensation, indicating a complete improvement in pressure touch sensation.

Table 5- Before and After Treatment Changes in Pain
Pain Before treatment After treatment
Number of patients Percentage (%) Number of patients Percentage (%)
Absent 1 3.33 0 0.00
Altered 28 93.33 7 23.33
Normal 1 3.33 23 76.67
Total 30 100.00 30 100.00

The data on pain sensation indicates notable improvement after treatment. Initially, 1 patient (3.33%) had no pain sensation, 28 patients (93.33%) had altered pain sensation, and 1 patient (3.33%) had normal pain sensation. Post-treatment, no patients had absent pain sensation, 7 patients (23.33%) still had altered sensation, and 23 patients (76.67%) achieved normal pain sensation, demonstrating a substantial shift toward normalized pain sensation and reduced impairment.
Table 6- Before and After Treatment Changes in Temperature
Temperature Before treatment After treatment
Number of patients Percentage (%) Number of patients Percentage (%)
Absent 0 0.00 0 0.00
Altered 29 96.67 0 0.00
Normal 1 3.33 30 100.00
Total 30 100.00 30 100.00

The data on temperature sensation reveals a marked improvement after treatment. Initially, none of the patients had absent temperature sensation, 29 (96.67%) had altered sensation, and only 1 (3.33%) had normal sensation. Post-treatment, all 30 patients (100%) achieved normal temperature sensation, with no cases of absent or altered sensation, demonstrating a complete restoration of normal temperature sensation across all patients.

Table 7- Before and After Treatment Changes in Vibration
Vibration Before treatment After treatment
Number of patients Percentage (%) Number of patients Percentage (%)
Absent 0 0.00 0 0.00
Altered 12 40.00 0 0.00
Normal 18 60.00 30 100.00
Total 30 100.00 30 100.00

The data on vibration sensation demonstrates substantial improvement post-treatment. Initially, none of the patients had absent vibration sensation, 12 (40%) had altered sensation, and 18 (60%) had normal sensation. After treatment, all 30 patients (100%) achieved normal vibration sensation, with no cases of absent or altered sensation, indicating a complete restoration of normal vibration sensation in all patients.
Table 8- Before and After Treatment Changes in Joint Position
Joint Position Before treatment After treatment
Number of patients Percentage (%) Number of patients Percentage (%)
Absent 0 0.00 0 0.00
Altered 3 10.00 0 0.00
Normal 27 90.00 30 100.00
Total 30 100.00 30 100.00


The data on joint position sensation shows improvement following treatment. Initially, none of the patients had absent joint position sensation, 3 (10%) had altered sensation, and 27 (90%) had normal sensation. After treatment, all 30 patients (100%) exhibited normal joint position sensation, with no cases of absent or altered sensation, reflecting a complete enhancement in joint position sensation across all patients.

While the invention is amenable to various modifications and alternative forms, some embodiments have been illustrated by way of example in the drawings and are described in detail above. The intention, however, is not to limit the invention by those examples and the invention is intended to cover all modifications, equivalents, and alternatives to the embodiments described in this specification.

The embodiments in the specification are described in a progressive manner and focus of description in each embodiment is the difference from other embodiments. For same or similar parts of each embodiment, reference may be made to each other.

It will be appreciated by those skilled in the art that the above description is in respect of preferred embodiments and that various alterations and modifications are possible within the broad scope of the appended claims without departing from the spirit of the invention with the necessary modifications. , Claims:We Claim:

1. An ayurvedic tablet formulation for neurological health comprising 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, 50-600 gm of Inula racemosa and 10-150 gm of Ferula foetida.

2. The ayurvedic tablet formulation as claimed in claim 1, wherein said formulation consists of 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, 100-500 gm of Inula racemosa and 30-100 gm of Ferula foetida.

3. The ayurvedic tablet formulation as claimed in claim 1, wherein said herbal blend formulation consists of 500-1200 gm of Clerodendrum phlomidis, 500-1200 gm of Gmelina arborea, 500-1200 gm of Aegle marmelos, 500-1200 gm of Oroxylum indicum, 500-1200 gm of Stereospermum suaveolens, 500-1200 gm of Desmodium gangeticum, 500-1200 gm of Uraria picta, 500-1200 gm of Solanum indicum, 500-1200 gm of Solanum xanthocarpum and 500-1200 gm of Tribulus terrestris.

4. A process for preparing an ayurvedic tablet formulation for neurological health comprising:
adding a herbal blend of coarsely powdered Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestrison in water and heating up to 80 - 100 degrees Celsius for around 7 - 9 hours to achieve decoction to obtain a resultant;
reducing the resultant to 1/16th of its original volume, yielding around 8 litres and filtering and further heating at 50 - 60°C for 2 to 5 hours to achieve a Ghana (thick extract) consistency, while being continuously stirred to prevent burning;
adding Prakshepa Dravya including purified adjuvants Ferula foetida (Hingu Churna) (powder) and Inula racemosa (Pushkarmoola Churna) (powder) into the Ghana upon removing from heat and mixing thoroughly, followed by adding other adjuvants 5% starch, 5% dicalcium phosphate, and 5% gum acacia to it;
blending of the Prakshepa Dravya (all adjuvants) with the Ghana employing a wet grinder to ensure the uniformity and placing resultant blend in a tray and drying the same at 50 - 60°C for 4 to 6 hours;
formulating the dried resultant by adding 3% talcum powder to ensure smooth tablet formation.
5. The process as claimed in claim 4, wherein the herbal blend used is comprising 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris.

6. The process as claimed in claim 4, wherein the adjuvant Inula racemosa used is in quantity of 50-600 gm and adjuvant Ferula foetida used is in quantity of 10-150 gm.

7. The process as claimed in claim 4, wherein the adjuvant Inula racemosa used is in quantity of 100-500 gm and adjuvant Ferula foetida used is in quantity of 30-100 gm.

8. The process as claimed in claim 4, wherein said formulation is prepared by using 5-12 kg of herbal blend of herbs consist of Clerodendrum phlomidis, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Stereospermum suaveolens, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris, 100-500 gm of adjuvant Inula racemosa and 30-100 gm of adjuvant Ferula foetida.

9. The herbal tablet formulation as claimed in claim 1, wherein said herbal blend formulation consists of 500-1200 gm of Clerodendrum phlomidis, 500-1200 gm of Gmelina arborea, 500-1200 gm of Aegle marmelos, 500-1200 gm of Oroxylum indicum, 500-1200 gm of Stereospermum suaveolens, 500-1200 gm of Desmodium gangeticum, 500-1200 gm of Uraria picta, 500-1200 gm of Solanum indicum, 500-1200 gm of Solanum xanthocarpum and 500-1200 gm of Tribulus terrestris.

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