DESC:DESCRIPTION:
Field of the invention:
[0001] The present disclosure generally relates to the technical field of natural products and pharmaceutical compositions, and in particular relates to a nutraceutical composition for managing hormonal imbalances in women, specifically targeting symptoms associated with polycystic ovarian syndrome (PCOS), with low to negligible side effects.
Background of the invention:
[0002] Hormonal imbalances in women, particularly those associated with polycystic ovarian syndrome (PCOS), present a significant health challenge globally. PCOS affects a substantial number of women during their reproductive years, manifesting in irregular menstrual cycles, insulin resistance, increased testosterone levels, and related symptoms such as excess hair growth and difficulties in conceiving. Current treatments for PCOS often involve medications that carry notable side effects, including irregular periods, heightened cancer risks, and complications like anemia and lactic acidosis.
[0003] Traditional approaches to managing PCOS typically include contraceptives to regulate menstrual cycles, metformin for addressing insulin resistance and diabetes, and estrogen supplements to boost hormone levels. However, these treatments are not universally suitable and may pose risks, particularly for individuals with underlying kidney or liver conditions.
[0004] The use of natural extracts from Ficus religiosa presents a promising alternative for PCOS management. Research has indicated that these extracts can enhance the activity of aromatase, an enzyme crucial for converting testosterone into estrogen. By promoting this enzymatic conversion, the composition aims to rebalance hormonal levels naturally, thereby alleviating symptoms associated with PCOS without directly affecting the ovaries or other reproductive organs.
[0005] Moreover, existing literature supports the efficacy and safety profile of Ficus religiosa in various therapeutic applications, underscoring its potential as a viable treatment option for PCOS. Studies have highlighted the plant's ability to modulate key pathways involved in steroidogenesis, further supporting its role in hormonal regulation.
[0006] Therefore, there is a need for a nutraceutical composition that manages hormonal imbalances in women, specifically targeting symptoms associated with polycystic ovarian syndrome (PCOS), with low to negligible side effects. There is also a need for a nutraceutical composition that leverages natural compounds to enhance aromatase activity. Further, there is also a need for a nutraceutical composition that provides a safer and potentially more effective alternative to current pharmaceutical interventions, thereby offering a promising path for women towards managing their PCOS symptoms with reduced risk of adverse effects.
Objectives of the invention:
[0007] The primary objective of the invention is to develop a nutraceutical composition that manages hormonal imbalances in women, specifically targeting symptoms associated with polycystic ovarian syndrome (PCOS), with low to negligible side effects.
[0008] Another objective of the invention is to develop a nutraceutical composition for PCOS that minimizes side effects commonly associated with traditional pharmaceutical intervention, thereby offering a promising path for women towards managing their PCOS symptoms with reduced risk of adverse effects.
[0009] The other objective of the invention is to develop a nutraceutical composition that enhances the efficiency of aromatase activity through Ficus religiosa leaf extracts, thereby promoting the conversion of testosterone into estrogen to restore hormonal balance in PCOS patients.
[0010] The other objective of the invention is to develop a nutraceutical composition that can be easily administered orally, ensuring convenience and compliance among PCOS.
[0011] Yet another objective of the invention is to develop a nutraceutical composition that does not directly affect the female reproductive organs, thereby minimizing the risk of adverse effects and ensuring the safety of long-term use.
[0012] Further objective of the invention is to develop a nutraceutical composition that regulates menstrual cycles, control excess hair growth, and manage hyperinsulinemia associated with PCOS, thereby improving overall quality of life for affected individuals.
Summary of the invention:
[0013] The present disclosure proposes a nutraceutical composition for polycystic ovarian syndrome and method of preparing the same. The following presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key/critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.
[0014] In order to overcome the above deficiencies of the prior art, the present disclosure is to solve the technical problem to provide a nutraceutical composition for managing hormonal imbalances in women, specifically targeting symptoms associated with polycystic ovarian syndrome (PCOS), with low to negligible side effects.
[0015] According to an aspect, the invention proposes a nutraceutical composition for PCOS that minimizes side effects commonly associated with traditional pharmaceutical intervention, thereby offering a promising path for women towards managing their PCOS symptoms with reduced risk of adverse effects. The nutraceutical composition regulates menstrual cycles, control excess hair growth, and manage hyperinsulinemia associated with PCOS, thereby improving overall quality of life for affected individuals.
[0016] In one embodiment herein, the nutraceutical composition is specifically prepared for polycystic ovarian syndrome (PCOS) through the use of an extract derived from the leaves of Ficus religiosa. This nutraceutical composition includes an effective amount of the extract, which has been shown to increase the activity of the enzyme aromatase.
[0017] Aromatase plays a crucial role in converting testosterone into estrone and estradiol, both forms of estrogen. By enhancing the activity of aromatase, the nutraceutical composition facilitates the conversion of excess testosterone into estrogens, thereby reducing testosterone levels in the bloodstream.
[0018] This reduction in testosterone levels is significant because it alleviates several symptoms associated with PCOS. These symptoms include irregular menstrual cycles, excess hair growth (hirsutism), and insulin resistance. Additionally, the increase in estrone and estradiol levels leads to elevated levels of Sex Hormone Binding Globulin (SHBG). SHBG binds to free testosterone in the bloodstream, further reducing its availability and mitigating the symptoms of hyperandrogenism commonly seen in PCOS patients.
[0019] The Ficus religiosa leaf extract used in this nutraceutical composition is prepared through a meticulous process. The leaves are first crushed and then air-dried. The air-dried leaves are powdered and subsequently encapsulated or tableted for oral administration. The encapsulated or tableted form ensures that the nutraceutical composition can be administered in a dose effective to increase aromatase activity.
[0020] In one embodiment, the nutraceutical composition is administered to a subject in need. The administration of the Ficus religiosa leaf extract increases the activity of aromatase in the subject, which in turn facilitates the conversion of testosterone into estrone and estradiol. This process effectively reduces testosterone levels in the bloodstream, alleviating symptoms such as irregular menstrual cycles, excess hair growth, and insulin resistance. Moreover, the increased levels of estrone and estradiol raise SHBG levels, which further binds to free testosterone, reducing its bioavailability and providing additional relief from PCOS symptoms.
[0021] According to an aspect, the method is disclosed in steps for preparing the nutraceutical composition for the polycystic ovarian syndrome (PCOS). First, at one step, the fresh leaves of the Ficus religiosa tree are harvested. At another step, the harvested leaves are thoroughly washed and cleaned to remove any dirt or impurities. At another step, the cleaned leaves are then crushed into smaller pieces to facilitate the drying process.
[0022] At another step, the crushed leaves are spread out in a well-ventilated area and allowed to air-dry completely, thereby ensuring the leaves are free of moisture, which can affect the stability of the final product. At another step, the dried leaves are finely powdered using a suitable milling or grinding process. The powdered leaves are subjected to an extraction process using a suitable solvent under controlled temperature and time to dissolve active components, thereby obtain a powdered leaves extract.
[0023] At another step, the powdered leaves extract is then encapsulated or compressed into capsules or tablets, thereby ensuring each unit contains a consistent and effective dose of the active ingredients. Further, at another step, the capsules or tablets are packaged in appropriate containers to ensure their stability and ease of use by the PCOS patients.
[0024] Overall, this nutraceutical composition offers a natural and effective method for managing PCOS by targeting and correcting the hormonal imbalances at the root of the condition, with the added benefit of being derived from a safe and natural source with negligible side effects.
[0025] Further, objects and advantages of the present invention will be apparent from a study of the following portion of the specification, the claims, and the attached drawings.
Detailed description of drawings:
[0026] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate an embodiment of the invention, and, together with the description, explain the principles of the invention.
[0027] FIG. 1 illustrates a schematic representation of a nutraceutical composition for converting testosterone into estrogen in patients with polycystic ovarian syndrome (PCOS), in accordance to an exemplary embodiment of the invention.
[0028] FIG. 2 illustrates a flowchart of a method of preparing the nutraceutical composition for PCOS, in accordance to an exemplary embodiment of the invention.
[0029] FIG. 3 illustrates an image of mass spectrometry (MS) analysis for aqueous extract of Ficus religiosa leaves.
[0030] FIG. 4 illustrates an image of mass spectrometry (MS) analysis for methanolic extract of Ficus religiosa leaves.
Detailed invention disclosure:
[0031] Various embodiments of the present invention will be described in reference to the accompanying drawings. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps.
[0032] The present disclosure has been made with a view towards solving the problem with the prior art described above, and it is an object of the present invention to provide a nutraceutical composition for managing hormonal imbalances in women, specifically targeting symptoms associated with polycystic ovarian syndrome (PCOS), with low to negligible side effects.
[0033] According to an example embodiment of the invention, FIG. 1 refers to a schematic representation of a nutraceutical composition 100 for converting testosterone into estrogen in patients with polycystic ovarian syndrome (PCOS). In one embodiment herein, the nutraceutical composition 100 for PCOS minimizes side effects commonly associated with traditional pharmaceutical intervention, thereby offering a promising path for women towards managing their PCOS symptoms with reduced risk of adverse effects. The nutraceutical composition 100 regulates menstrual cycles, control excess hair growth, and manage hyperinsulinemia associated with PCOS, thereby improving overall quality of life for affected individuals.
[0034] In one embodiment herein, the nutraceutical composition 100 is derived from the leaves of the Ficus religiosa tree, intended for polycystic ovarian syndrome (PCOS). The nutraceutical composition 100 is prepared through a specific process where the leaves of Ficus religiosa are harvested, crushed, and then air-dried. Once thoroughly dried, the leaves are finely powdered. This powdered form is then encapsulated or compressed into tablets, designed for oral administration. This method ensures the preservation of the active components within the leaves that are essential for the therapeutic effect.
[0035] In one embodiment herein, the nutraceutical composition 100 targets the enzymatic activity of aromatase, a critical enzyme involved in steroidogenesis upon ingestion. Aromatase catalyzes the conversion of androgens, specifically testosterone, into estrogens, such as estrone and estradiol. By increasing the levels of aromatase, the nutraceutical composition 100 enhances the conversion process, thereby elevating the levels of estrone and estradiol while simultaneously reducing the levels of testosterone in the bloodstream. This biochemical shift is crucial in managing the symptoms associated with the PCOS.
[0036] In one embodiment herein, the primary therapeutic action of the nutraceutical composition 100 is to restore hormonal balance in women suffering from the PCOS. Elevated testosterone levels are a hallmark of the PCOS, leading to symptoms such as irregular menstrual cycles, hirsutism (excess hair growth), and insulin resistance. By converting excess testosterone into estrogens, the nutraceutical composition 100 reduces these symptoms. The increase in estrogen levels also promotes the production of Sex Hormone Binding Globulin (SHBG), a protein that binds to free testosterone in the bloodstream. SHBG has a high affinity for testosterone, and its increased levels further reduce the bioavailability of testosterone, amplifying the therapeutic effect of the nutraceutical composition 100.
[0037] In one embodiment herein, the reduction in testosterone levels and the concomitant increase in estrogen levels lead to several clinical benefits. Regular menstrual cycles are restored as the hormonal milieu is balanced. Excess hair growth, a result of hyperandrogenism, is mitigated, and the overall cosmetic and psychological burden of hirsutism is lessened. Additionally, by improving the estrogen to testosterone ratio, the nutraceutical composition 100 aids in reducing insulin resistance, a common metabolic issue in the PCOS patients. This improvement in insulin sensitivity can help in managing weight and reducing the risk of developing type 2 diabetes.
[0038] In one embodiment herein, the nutraceutical composition 100 is derived from a natural source, Ficus religiosa, known for its minimal side effects. The natural origin of the extract ensures that it does not interfere directly with the ovaries or other reproductive organs, thereby avoiding the adverse effects associated with synthetic hormonal. This safety profile makes the nutraceutical composition 100 a viable long-term therapeutic option for managing the PCOS.
[0039] In one embodiment herein, the administration of the nutraceutical composition 100 is straightforward. Patients are instructed to take the capsules or tablets orally, following a dosage regimen determined by healthcare professionals based on the severity of their symptoms and their individual response to the nutraceutical composition 100. Consistent use of the nutraceutical composition 100 is essential to maintain the increased aromatase activity and sustain the therapeutic benefits.
[0040] In one embodiment herein, the nutraceutical composition 100 derived from Ficus religiosa offers a natural, safe, and effective option for the PCOS. By enhancing aromatase activity, it converts excess testosterone to estrogens, thereby restoring hormonal balance and alleviating the symptoms of the PCOS, including irregular menstrual cycles, hirsutism, and insulin resistance. The nutraceutical composition's natural ingredients ensure minimal side effects, making it a sustainable and patient-friendly approach to managing the PCOS.
[0041] According to another example embodiment of the invention, FIG. 2 refers to a flowchart 200 of a method of preparing the nutraceutical composition 100 for the polycystic ovarian syndrome (PCOS). First, at step 202, the fresh leaves of the Ficus religiosa tree are harvested. At step 204, the harvested leaves are thoroughly washed and cleaned to remove any dirt or impurities. At step 206, the cleaned leaves are then crushed into smaller pieces to facilitate the drying process.
[0042] At step 208, the crushed leaves are spread out in a well-ventilated area and allowed to air-dry completely, thereby ensuring the leaves are free of moisture, which can affect the stability of the final product. At step 210, the dried leaves are finely powdered using a suitable milling or grinding process.
[0043] In another embodiment, the powdered leaves are subjected to an extraction process using a suitable solvent under controlled temperature and time to dissolve active components, thereby obtaining a solvent mixture. In one embodiment, the suitable solvent comprises, but not limited to, ethanol, methanol, water, or hydro-alcoholic mixture. Later, the solvent mixture is filtered to separate the liquid extract from the plant residue. Then, the filtrate is concentrated by rotary evaporation or vacuum drying to obtain a concentrated Ficus religiosa leaf extract. Next, the Ficus religiosa leaf extract is dried by at least one spray drying and freeze drying to yield a powdered leaves extract form for encapsulation or tablet compression.
[0044] At step 212, the powdered leaves extract is then encapsulated or compressed into capsules or tablets, thereby ensuring each unit contains a consistent and effective dose of the active components. Further, at step 214, the capsules or tablets are packaged in appropriate containers to ensure their stability and ease of use by the PCOS patients.
[0045] In one embodiment herein, the nutraceutical composition 100 comprises 3-acetoxy-3-hydroxy propionic acid (3AHPA) as a primary bioactive component, wherein 3AHPA is configured to enhance aromatase enzyme activity in a subject in need thereof. The increased aromatase activity facilitates the biochemical conversion of excess testosterone to estrogen, thereby correcting hormonal imbalance associated with PCOS. In preclinical models, 3AHPA has been demonstrated to increase aromatase activity in mammals, such as rats and mice, which exhibit physiological similarities to humans.
[0046] In certain embodiments, the nutraceutical composition 100 is prepared from an aqueous extract of Ficus religiosa leaves, the aqueous extract being preferred over methanolic extract due to its selectivity in extracting 3AHPA while minimizing the co-extraction of undesirable components. In some embodiments, the composition may be administered as a standalone formulation or in combination with one or more existing therapeutic agents for PCOS management, wherein such combination exhibits a synergistic effect in regulating hormonal balance.
[0047] According to another example embodiment of the invention, FIG. 3 refers to an image 300 of mass spectrometry (MS) analysis for aqueous extracts of Ficus religiosa leaves. FIG. 4 refers to an image 400 of mass spectrometry (MS) analysis for methanolic extracts of Ficus religiosa leaves. Mass spectrometry (MS) analysis of both aqueous and methanolic extracts of Ficus religiosa leaves revealed the presence of 3-acetoxy-3-hydroxy propionic acid (3AHPA) as the major constituent. The 3AHPA was detected in both spectra in molecular ion forms M (molecular weight: 162) and [M-H] (molecular weight: 160.8), confirming its identity and high hydrophilicity. Given that methanol is the most polar organic solvent after water in the hydrophilicity index, both aqueous and methanolic extracts successfully solubilized 3AHPA; however, the aqueous extract demonstrated higher selectivity and reduced non-target co-extraction.
[0048] In one embodiment, the preparation method comprises extracting Ficus religiosa leaf material using deionized water to obtain the aqueous extract or methanol to obtain the methanolic extract, followed by subjecting the extract to phytochemical profiling via MS analysis to confirm the presence and concentration of 3AHPA. In both extract types, the MS spectra exhibited a peak corresponding to 3AHPA with approximately 100% relative intensity, indicating its predominance as the principal active ingredient. Representative spectral images are provided herein for reference.
[0049] Numerous advantages of the present disclosure may be apparent from the discussion above. In accordance with the present disclosure, a nutraceutical composition for managing hormonal imbalances in women, specifically targeting symptoms associated with polycystic ovarian syndrome (PCOS), with low to negligible side effects.
[0050] The nutraceutical composition for PCOS minimizes side effects commonly associated with traditional pharmaceutical intervention, thereby offering a promising path for women towards managing their PCOS symptoms with reduced risk of adverse effects. The nutraceutical composition enhances the efficiency of aromatase activity through Ficus religiosa leaf extracts, thereby promoting the conversion of testosterone into estrogen to restore hormonal balance in PCOS patients.
[0051] The nutraceutical composition can be easily administered orally, ensuring convenience and compliance among PCOS. The nutraceutical composition does not directly affect the female reproductive organs, thereby minimizing the risk of adverse effects and ensuring the safety of long-term use. The nutraceutical composition regulates menstrual cycles, control excess hair growth, and manage hyperinsulinemia associated with PCOS, thereby improving overall quality of life for affected individuals.
[0052] It will readily be apparent that numerous modifications and alterations can be made to the processes described in the foregoing examples without departing from the principles underlying the invention, and all such modifications and alterations are intended to be embraced by this application.
,CLAIMS:CLAIMS:
I / We Claim:
1. A method of preparing a nutraceutical composition (100), comprising:
harvesting fresh leaves of the Ficus religiosa tree;
washing and cleaning the harvested leaves thoroughly to remove any dirt or impurities;
crushing the cleaned leaves into smaller pieces to facilitate a drying process;
spreading the crushed leaves in a well-ventilated area and allowed to air-dry completely to obtain dried leaves;
powdering the dried leaves finely in a powdered leaves using a suitable milling or grinding process, followed by subjecting the powdered leaves to an extraction process to obtain a powdered leaves extract;
encapsulating and compressing the powdered leaves extract into at least one of capsules and tablets of obtain the nutraceutical composition (100), thereby ensuring each unit contains a consistent and effective dose of the powdered leaves; and
packing the nutraceutical composition (100) in appropriate containers.
2. The method of preparing a nutraceutical composition (100) as claimed in claim 1, wherein the extraction process is preformed using a suitable solvent to dissolve active components.
3. The method of preparing a nutraceutical composition (100) as claimed in claim 1, wherein the nutraceutical composition (100) comprises 3-acetoxy-3-hydroxy propionic acid (3AHPA), which increases aromatase activity.