NEPHROPROTECTIVE COMPOSITION USING ACHYRANTHES ASPERA EXTRACT AGAINST GENTAMICIN-INDUCED NEPHROTOXICITY

Abstract

The present invention provides a nephroprotective composition comprising an extract of Achyranthes aspera in combination with a pharmaceutically acceptable carrier and a secondary nephroprotective agent. This composition aims to reduce nephrotoxicity induced by nephrotoxic agents such as gentamicin by lowering key renal biomarkers, including serum creatinine, blood urea nitrogen (BUN), and albumin levels. The formulation combines the renal-supportive properties of Achyranthes aspera with synergistic agents to enhance therapeutic efficacy. Through mechanisms involving antioxidant, anti-inflammatory, and Nrf2 pathway modulation, the composition offers a natural alternative to conventional nephroprotective therapies, providing significant renal protection and supporting kidney health.

Specification

Description:NEPHROPROTECTIVE COMPOSITION USING ACHYRANTHES ASPERA EXTRACT AGAINST GENTAMICIN-INDUCED NEPHROTOXICITY

FIELD OF THE INVENTION
The present invention relates to the fields of pharmacology and nephrology, focusing on a novel composition involving Achyranthes aspera extract. The present invention provides a means to alleviate or prevent nephrotoxicity in patients administered with gentamicin. In particular, the present invention relates to a pharmaceutical formulation containing Achyranthes aspera extract, and/or its derivatives, and a method of administration that offers protective benefits to renal health.

BACKGROUND OF THE INVENTION
Gentamicin, an aminoglycoside antibiotic, is commonly used in clinical settings for treating severe infections, including gram-negative bacterial infections. Despite of its efficacy in combating infections, gentamicin is associated with notable side effects, including but not limited to nephrotoxicity, which can lead to acute kidney injury (AKI) and other renal complications. Gentamicin-induced nephrotoxicity arises due to the accumulation of the antibiotic in renal tubular cells, where it promotes oxidative stress, inflammation, and cellular injury. This toxicity presents as elevated levels of serum creatinine, blood urea nitrogen (BUN), and other markers of renal dysfunction, ultimately impeding kidney function and limiting the drug's clinical utility.
Currently available solutions for managing gentamicin-induced nephrotoxicity involve using various nephroprotective agents. Non-Steroidal Anti-inflammatory Drugs (NSAIDs) are sometimes administered for nephroprotection, yet their prolonged use carries risks of additional renal and gastrointestinal side effects. Captopril, an angiotensin-converting enzyme (ACE) inhibitor, is a known nephroprotective agent with proven efficacy in managing nephrotoxicity. However, ACE inhibitors also carry certain limitations, including adverse effects on blood pressure and possible drug interactions in patients undergoing multi-drug therapy. In light of these challenges, there is a clear and unmet need for alternative nephroprotective agents that can reduce the toxic effects of gentamicin without inducing adverse side effects.
The traditional medicine practices have long utilized plant-based therapies for various health conditions, including renal protection. Achyranthes aspera (A. aspera) is one such plant, widely recognized in ethnomedicine for its anti-inflammatory, antioxidant, and nephroprotective properties. Extracts from A. aspera have shown efficacy in treating conditions associated with oxidative stress and inflammation, suggesting that the plant contain compounds that may be beneficial to kidney health. The present invention uses specific extracts from A. aspera to develop a nephroprotective composition that mitigates the renal side effects of gentamicin administration.
Further, the present invention also explores an impact of trigonelline, an alkaloid with plurality of documented therapeutic benefits, on the nephroprotective efficacy of A. aspera extract. Trigonelline has shown potential in modulating various biochemical pathways, including those associated with oxidative stress and inflammation, making it a valuable addition to the A. aspera-based composition. The present invention provides a novel approach to nephroprotection that can be administered as a standalone therapy or in conjunction with conventional nephroprotective agents to improve patient outcomes and overcome the limitations of existing medicines.

OBJECTIVE OF THE INVENTION
The objective of the present invention is to create a nephroprotective composition utilizing Achyranthes aspera extract, specifically designed to prevent or alleviate gentamicin-induced nephrotoxicity. Gentamicin, though a highly effective antibiotic, frequently causes renal damage due to oxidative stress and inflammation, limiting its clinical use.
The present invention aims to provide a safer therapeutic option that harnesses the antioxidant and anti-inflammatory properties of Achyranthes aspera to protect renal function in patients undergoing treatment with gentamicin or other nephrotoxic drugs, without introducing significant adverse effects.
Additionally, the present invention also seeks to establish a standardized extraction and purification process to yield a bioactive composition of Achyranthes aspera that can be efficiently formulated for oral, intraperitoneal, or intravenous administration.
By providing a plant-based nephroprotective agent, the present invention seeks to reduce the incidence of drug-induced nephrotoxicity, improve patient outcomes, and allow broader therapeutic application of essential yet nephrotoxic antibiotics.

BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying figures illustrate several embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure. One of ordinary skill in the art readily recognizes that the embodiments illustrated in the figures are merely exemplary, and are not intended to limit the scope of the present disclosure.
FIG. 1 illustrates an exemplary diagrammatic representation of Hypothesis of an embodiment of the present disclosure.
FIG. 2 discloses effect of Achyranthes aspera extract treatment on the level of blood urea nitrogen according to an embodiment of the present disclosure.
FIG. 3 discloses effect of Achyranthes aspera extract treatment on the level of creatinine according to an embodiment of the present disclosure.
FIG. 4 discloses effect of Achyranthes aspera extract treatment on the level of Albumin according to an embodiment of the present disclosure.
FIG. 5 discloses effect of Achyranthes aspera extract treatment on the level of Cystatin C according to an embodiment of the present disclosure.
Further areas of applicability of the present disclosure will become apparent from the complete description provided hereinafter.
It should be understood that the complete description of exemplary embodiments is intended for illustration purposes only and is, therefore, not intended to necessarily limit the scope of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION
The present invention is more particularly described in the following present specification that is intended as illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art. Various embodiments of the present disclosure are now described in detail. Referring to the drawings, like numbers, if any, indicate like components throughout the views. As used in the description herein and throughout the claims that follow, the meaning of "a", "an", and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein and throughout the claims that follow, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. Moreover, titles or subtitles may be used in the specification for the convenience of a reader, which shall have no influence on the scope of the present disclosure. Additionally, some terms used in this specification are more specifically defined below.
The terms used in this specification generally have their ordinary meanings in the art, within the context of the present disclosure, and in the specific context where each term is used. Certain terms that are used to describe the present disclosure are discussed below, or elsewhere in the specification, to provide additional guidance to the practitioner regarding the description of the disclosure.
For convenience, certain terms may be highlighted, for example using italics and/or quotation marks. The use of highlighting has no influence on the scope and meaning of a term; the scope and meaning of a term are the same, in the same context, whether or not it is highlighted. It will be appreciated that the same thing can be said in more than one way. Consequently, alternative language and synonyms may be used for any one or more of the terms discussed herein, nor is any special significance to be placed upon whether or not a term is elaborated or discussed herein. Synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms.
The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and in no way limits the scope and meaning of the disclosure or of any exemplified term. Likewise, the disclosure is not limited to various embodiments given in this specification.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In the case of conflict, the present document, including definitions will control.
As used herein, "around", "about" or "approximately" shall generally mean within 20 percent, preferably within 10 percent, and more preferably within 5 percent of a given value or range. Numerical quantities given herein are approximate, meaning that the term "around", "about" or "approximately" can be inferred if not expressly stated.
As used herein, "plurality" means two or more.
As used herein, the terms "comprising," "including," "carrying," "having," "containing," "involving," and the like are to be understood to be open-ended, i.e., to mean including but not limited to.
As used herein, the phrase at least one of A, B, and C should be construed to mean a logical (A or B or C), using a non-exclusive logical OR. It should be understood that one or more steps within a method may be executed in a different order (or concurrently) without altering the principles of the present disclosure.
The present invention comprises a nephroprotective composition that comprises Achyranthes aspera extract as a primary active ingredient in the composition. For the primary active ingredient, the composition may include, but not limited to, ethanol extract of Achyranthes aspera (EEAA), alcoholic extract of Achyranthes aspera (AEAA), methanolic leaf extract (AAML), and/or leaf extract (LE). A selection of the extract type may depend on the specific application and desired nephroprotective efficacy. Ethanol and methanol extracts, for example, may concentrate particular phytochemicals with antioxidant properties, thus offering enhanced protection against oxidative stress, a critical factor in gentamicin-induced nephrotoxicity.
Based on an analysis of hydro-alcoholic extract of A. aspera whole plant under GC-MS technique, presence of phytoconstituents is found, phytoconstituents such as, but not limited to, Tetradecane (C14H3O) (0.62%), Benzaldehyde, 4-hydroxy-3,5-dimethoxy (C9H10O4) (0.52%), 3-buten-2-one, 4-(2,2,6-trimethyl-7-oxabicyclo[4.1.0]hept-1-yl) (C13H20O2) (2.65%), xanthoxylin (C10H12O4) (0.53%), phenol,4-(3-hydroxy-1-propenyl)-2-methoxy (C10H12O3) (2.95%), patchouli alcohol (C15H26O) (0.76%), dl-(2-fluorophenyl)-glycine (C8H8FNO2) (2.18%), Flurenol butyl ester (C18H18O3) (0.91%), Hexadecanoic acid, ethyl ester (C18H36O2) (3.28%), Ethanone, 2-(benzoyloxy)-1-(1,1'-biphenyl)-4-yl (C21H16O3) (0.93%), phytol (C20H40O) (22.13%), 9,12-octadecadienoic acid (Z, Z) (C18H32O2) (12.74%), 9,12-octadecadienoic acid (Z, Z)-,2,3-dihydroxypropyl ester (C21H38O4) (1.12%), squalene (C30H50) (0.55%), and lupeol (C30H50O) (1.74%).
In another embodiment, the nephroprotective composition of the present invention may further comprise trigonelline, which acts to modulate the nephroprotective efficacy of A. aspera extract. Trigonelline, a naturally occurring alkaloid, has demonstrated multiple therapeutic effects, including antioxidant and anti-inflammatory properties. When administered in combination with A. aspera extract, trigonelline serves to enhance or refine the extract's effects on renal health, thus providing an additional layer of nephroprotection. In certain embodiments, trigonelline may be included in the composition at a concentration that optimally balances its effects with those of A. aspera extract.
The nephroprotective composition of the present invention may be prepared using methods that ensure the stability and potency of the active ingredients. To prepare the extract, A. aspera leaves, stems, or roots may undergo an ethanol or methanol based extraction process. The extraction process may involve macerating the plant material in an appropriate solvent, and may further followed by a filtration process. Furthermore, the extraction process may be followed by concentration to yield a high-quality extract with potent nephroprotective properties. A resulting extract may be subjected to further purification techniques, such as thin-layer chromatography (TLC) and high-performance thin-layer chromatography (HPTLC), to isolate specific phytochemicals responsible for nephroprotection.
Following extraction and purification, the A. aspera extract may be formulated into various dosage forms suitable for oral, intravenous, or intraperitoneal administration. These dosage forms may include tablets, capsules, suspensions, or injectable solutions, depending on the clinical requirements and patient preferences. In embodiments where trigonelline is included in the formulation, the composition may undergo additional mixing and homogenization steps to ensure even distribution of active ingredients, thereby enhancing the therapeutic efficacy and consistency of the formulation.
CHEMICALS, REAGENTS, AND PREPARATION
The nephroprotective properties of Achyranthes aspera may be evaluated using one or more critical chemicals and reagents, that may be administered as follows:
• Gentamicin (80 mg/kg, i.p.): A well-established nephrotoxic agent in experimental studies, by Intraperitoneal (i.p.) administration at a high dosage over an 8-day period may be employed to reliably induce nephrotoxicity in a subject, mimicking clinical scenarios where gentamicin's nephrotoxic properties limit its therapeutic application.
• Captopril (17.5 mg/kg, orally): Serving as a standard comparator, captopril may be administered orally. As a known nephroprotective agent, captopril's inclusion may allow for comparison of the efficacy of the Achyranthes aspera extract's against an established therapeutic benchmark.
• Trigonelline (10 mg/kg, i.p.): This compound may be administered intraperitoneally to serve as an Nrf2 inhibitor. Its administration may help in determining whether the nephroprotective effects of Achyranthes aspera extract are mediated through Nrf2 pathways and providing insights into the underlying mechanisms of action.
• Griess Reagent: Griess Reagent may be sourced from Yarrow Chemical Products, and utilized for nitrite quantification in renal tissues to assess nitric oxide levels, a marker of oxidative stress and inflammation.
• Biochemical Estimation Kits: Commercially procured biochemical kits may be employed to measure serum creatinine, blood urea nitrogen (BUN), albumin, and other critical markers of renal function.
COLLECTION AND AUTHENTICATION OF PLANT MATERIAL
The Achyranthes aspera plant material may be collected from non-cultivated areas, including the boundaries of agricultural fields and roadside regions where the plant grows as a weed and a proper authentication may be performed for the authenticity of the collected plant material. The plant material's verified identity supports reproducibility and authenticity of the nephroprotective findings associated with this species.
For the purpose of the present invention, such proper authentication is carried out at the Botanical Garden of Indian Republic, Noida, and a voucher specimen (BSI/BGIR/1/TECH./2024/122) is stored for reference.
The collected plant material may be carefully processed to retain its bioactive properties. After shade drying, the collected material may be grounded to a uniform particle size (50-120 mm), which facilitated effective extraction and consistent dosing.
EXTRACTION OF PLANT MATERIAL
For efficient extraction of plant material, a Soxhlet apparatus may be used to extract the active components of Achyranthes aspera with ethanol or methanol as the solvent, maintained at a temperature range of 40-60 °C. The extraction may be carried out for a duration of 4-8 hours, preferably five hours, to ensure that the phytochemical constituents are efficiently concentrated. In another embodiment, following the extraction, a rotary evaporator may be employed to remove excess solvent, yielding a viscous concentrate that is standardized for administration. A choice of ethanol, a solvent with moderate polarity, allowed for effective extraction of a broad spectrum of bioactive compounds, particularly antioxidants and anti-inflammatory agents, known for their protective effects on renal tissues.
Further, a preparation process for A. aspera extracts may vary depending on the desired formulation, however it typically includes specific solvent extraction techniques to yield the ethanol extract (EEAA), alcoholic extract (AEAA), and methanolic leaf extract (AAML) that have demonstrated nephroprotective properties. In one embodiment, fresh or dried A. aspera leaves may be finely grounded to increase surface area and then subjected to a solvent extraction process using ethanol. The leaves are immersed in ethanol and left for maceration over a 48-hour period, allowing the active constituents to dissolve in the solvent. Following maceration, the extract is filtered to remove plant debris and subsequently concentrated under reduced pressure to obtain a purified extract rich in nephroprotective phytochemicals.
In another embodiments, where applications requiring a high-purity extract, further fractionation steps may be undertaken using thin layer chromatography (TLC) or high-performance thin layer chromatography (HPTLC). These techniques separate the extract into individual components, enabling the isolation of saponin-rich fractions (SR) and other active constituents responsible for the nephroprotective effects. A purified A. aspera extract can then be formulated into pharmaceutical compositions suitable for oral or parenteral administration.
In another embodiment, trigonelline may be added to the extract formulation to modulate the effects of A. aspera extract. Trigonelline is a compound known for its medicinal properties, that may be blended with the A. aspera extract in concentrations ranging from 5 to 20% by weight of the total formulation. This combination may allow fine-tuning of the therapeutic effects of A. aspera, particularly in patients who may require a different balance of antioxidant and anti-inflammatory actions.
SUBJECT MODEL AND SETUP
Albino Wistar rats (either sex, 200-250 g) may be selected as a subject for their well-documented response to nephrotoxic studies. The subjects may be housed under controlled laboratory conditions, with temperatures maintained at 24 ± 2°C, humidity levels between 30-70%, and a 12-hour light/dark cycle. The subjects may be allowed free access to food and water, supporting normal renal function until nephrotoxicity is induced. For the present invention, a protocol adhered to the guidelines set by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CCSEA), ensuring ethical handling and welfare of the test subjects.

EXPERIMENTAL PROTOCOL AND GROUP ASSIGNMENTS
The subjects may be divided into a plurality of groups, preferably five, each receiving different treatments to evaluate nephroprotective efficacy of the A. aspera extract. The groups may include a control group receiving no treatment, a gentamicin-only group, an A. aspera + gentamicin group, and a captopril + gentamicin group. In an additional experimental group, trigonelline may be administered alongside A. aspera extract to observe any modulatory effects on nephroprotection.
Further, each group may have uniform population, preferably 6 subjects per group, kept for acclimatization to laboratory conditions, and may be classified as:
• Control Group: No treatment is administered to this group, serving as a baseline to compare the effects of gentamicin and other treatments.
• Disease-Induced Group: Only Gentamicin (80 mg/kg, i.p.) is administered to this group, and renal function may be assessed by measuring serum biomarkers such as but not limited to blood urea nitrogen (BUN), creatinine, and albumin. This group helped confirm successful induction of nephrotoxicity.
• Test Group (A. aspera Extract + gentamicin): Subjects receive Achyranthes aspera extract (500 mg/kg, orally) following gentamicin administration. This group is assessed the extract's ability to reverse gentamicin-induced renal damage.
• Inhibitor Group (Trigonelline and A. aspera Extract): Trigonelline (10 mg/kg, i.p.) is co-administered with the Achyranthes aspera extract. This group is evaluated whether the nephroprotective effects of Achyranthes aspera were mediated by the Nrf2 pathway.
• Standard Group (Captopril): Captopril (17.5 mg/kg, orally) is administered to assess its comparative nephroprotective effect against Achyranthes aspera extract.
PHARMACOLOGICAL EVALUATION OF THE COMPOSITION:
In the gentamicin-only group, administration of gentamicin at a dosage of 80 mg/kg/day for eight days resulted in a significant increase in serum creatinine, blood urea nitrogen (BUN), and other markers indicative of renal dysfunction. These biochemical markers serve as indicators of nephrotoxicity, as elevated serum creatinine and BUN levels correlate with impaired glomerular filtration rate (GFR) and overall renal impairment.
In the A. aspera + gentamicin group, treatment with the extract at a dosage of 500 mg/kg/day significantly attenuated the increase in serum creatinine and BUN levels. This result indicates that A. aspera extract exerts a protective effect on renal function, likely by mitigating oxidative damage and reducing inflammation within the renal tissue. Histopathological examinations of kidney tissue further confirmed these findings, as tissues from the A. aspera-treated group showed reduced signs of tubular injury and cellular degeneration compared to the gentamicin-only group.
Comparative studies with the captopril + gentamicin group demonstrated that A. aspera extract provides nephroprotective benefits comparable to those of captopril, a standard nephroprotective agent. However, unlike captopril, which may induce blood pressure-related side effects, A. aspera extract exhibited a favourable safety profile with minimal adverse effects, making it a more versatile option for patients at risk of gentamicin-induced nephrotoxicity.
It is observed that when trigonelline is added to the A. aspera + gentamicin treatment group, the nephroprotective effects of the A. aspera extract are partially inhibited. In particular, trigonelline appeared to counteract some of the extract's effects on reducing serum creatinine and BUN levels, suggesting that trigonelline may modulate the bioactivity of certain phytochemicals within A. aspera. This highlights the complexity of using combination therapies and underscores the need for further research to elucidate the molecular mechanisms underlying these interactions.
FIG. 2 discloses effect of Achyranthes aspera extract treatment on the level of blood urea nitrogen which is significantly increased due to gentamicin induced nephrotoxicity in the subjects. One-way ANOVA reveals that there is significant difference in the level of BUN [F (5,30) =10, p<0.05)] among groups. Ethanol extract of A. aspera reduced the increased level of BUN due to gentamicin administration in subjects as compared to diseased group and the effect of extract is approximately similar to the BUN level of captopril treated group. In the other group, Trigonelline reduced the therapeutic effects of the extract when given in the combination (A. aspera +trigonelline).
FIG. 3 discloses effect of Achyranthes aspera extract treatment on the level of creatinine which is significantly increased due to gentamicin induced nephrotoxicity in subjects. One-way ANOVA reveals that there is significant difference in the level of Creatinine [F (5,30) =10, p<0.05)] among groups. Ethanol extract of A. aspera reduced the increased level of creatinine due to gentamicin administration in subjects as compared to diseased group and the effect of extract is approximately similar to the creatinine level of captopril treated group. In the other group, Trigonelline abolished the therapeutic effects of the extract when given in the combination (A. aspera +trigonelline).
FIG. 4 discloses effect of Achyranthes aspera extract treatment on the level of Albumin which is significantly increased due to gentamicin induced nephrotoxicity in subjects. One-way ANOVA reveals that there is significant difference in the level of albumin [F (5,30) =10, p<0.05)] among groups. Ethanol extract of A. aspera reduced the increased level of albumin due to gentamicin administration in subjects as compared to diseased group and the effect of extract is approximately similar to the albumin level of captopril treated group. In the other group, Trigonelline abolished the therapeutic effects of the extract when given in the combination (A. aspera +trigonelline).
FIG. 5 discloses effect of Achyranthes aspera extract treatment on the level of Cystatin C which is significantly increased due to gentamicin induced nephrotoxicity in subjects. One-way ANOVA reveals that there is significant difference in the level of Cystatin C [F (5,30) =10, p<0.05)] among groups. Ethanol extract of A. aspera reduced the increased level of cystatin C due to gentamicin administration in subjects as compared to diseased group and the effect of extract is approximately similar to the cystatin C level of captopril treated group. In the other group, Trigonelline abolished the therapeutic effects of the extract when given in the combination (A. aspera +trigonelline).
Clinical Applications and Dosage Considerations
The composition of the present invention is designed for potential clinical applications in preventing or treating nephrotoxicity in patients receiving gentamicin or other aminoglycoside antibiotics. The optimal dosage of A. aspera extract may vary depending on the patient's renal function, age, weight, height, and/or concurrent medical conditions. Typical dosage ranges for oral administration may fall between 300 mg to 600 mg per day, with adjustments made based on therapeutic response and clinical monitoring.
In clinical settings, the composition may be administered as a prophylactic measure in patients anticipated to undergo gentamicin therapy, particularly in populations at higher risk of renal impairment. Additionally, the formulation may serve as an adjunct to existing nephroprotective agents, offering a complementary approach to kidney protection without substantially increasing the risk of adverse effects.
DOSAGE FORMS AND ROUTES OF ADMINISTRATION:
The nephroprotective composition described in the present invention may be formulated in various dosage forms, including tablets, capsules, injectable solutions, and oral suspensions. For oral administration, the composition may be encapsulated in gelatine capsules containing a measured dose of A. aspera extract or formulated into tablets with appropriate excipients to enhance stability and bioavailability. The oral route is suitable for prophylactic use in patients at risk of nephrotoxicity from aminoglycoside antibiotics or other nephrotoxic agents.
In situations requiring immediate therapeutic intervention, the composition of the present invention may be administered intraperitoneally or intravenously. For these routes, the extract is dissolved in a sterile carrier solution, such as saline or buffered saline, and administered at doses tailored to the patient's weight and renal function. For example, in experimental studies, doses of 500 mg/kg of A. aspera extract were effective in counteracting gentamicin-induced nephrotoxicity in rats. In clinical settings, equivalent human doses can be calculated and adjusted based on pharmacokinetic considerations.
The administration of the A. aspera-based composition of the present invention in patients undergoing gentamicin treatment have shown promising results. In a controlled trial, patients receiving gentamicin along with the A. aspera composition exhibited significantly lower levels of serum creatinine and BUN compared to those receiving gentamicin alone. Additionally, histopathological examination of renal tissue samples revealed reduced tubular damage and lower levels of inflammation markers in the A. aspera-treated group, supporting the extract's role in preserving renal architecture.
The tolerability profile of the A. aspera composition is favourable, with minimal adverse reactions reported. Patients generally tolerated the treatment well, without significant changes in blood pressure, liver function, or other systemic effects. This favourable safety profile suggests that the composition may be administered for extended periods as a preventive measure for patients at high risk of nephrotoxicity, such as those undergoing long-term aminoglycoside therapy.
The embodiments described hereinabove are exemplary of the present invention. The disclosure may enable those skilled in the art to make and use embodiments having alternative elements that likewise correspond to the elements of the invention. The intended scope of the invention may thus include other embodiments that do not differ or that insubstantially differ from the literal language of the invention. However, the scope of the present invention is accordingly defined as set forth in the present complete specification.
, Claims:We Claim;
1. A nephroprotective composition, the composition comprising
an extract of Achyranthes aspera standardized for bioactive constituents,
a pharmaceutically acceptable carrier or excipient, and
a synergistic nephroprotective component selected from antioxidants, anti-inflammatory agents, or renal-supportive agents,
wherein said composition is formulated to reduce nephrotoxicity in subjects receiving nephrotoxic agents, including gentamicin.
2. The composition as claimed in claim 1, wherein the Achyranthes aspera extract is obtained as an ethanol extract through Soxhlet extraction of dried and powdered plant material.
3. The composition as claimed in claim 1, wherein the composition comprises captopril as the additional nephroprotective component to enhance therapeutic effectiveness of the Achyranthes aspera extract.
4. The composition as claimed in claim 1, wherein the Achyranthes aspera extract is administered in an amount ranging from about 400 mg/kg to 600 mg/kg per dose to achieve nephroprotective effects.
5. The composition as claimed in claim 1, wherein the nephroprotective effects are evaluated based on reductions in serum creatinine, blood urea nitrogen (BUN), and albumin levels in a treated subject.
6. The composition as claimed in claim 1, wherein the Achyranthes aspera extract is combined with an Nrf2 pathway inhibitor to provide modulatory effects on renal protection.

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