Shatavari for Menopause

Overseen By John Ademola

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Herbal extracts, HRT, Glucocorticoids

Disqualifiers: Substance abuse, Cancer, Major diseases, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

51 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking medications that affect bone metabolism, like glucocorticoids, anticonvulsants, or methotrexate, or if you have been on hormone replacement therapy for more than 3 months.

What data supports the idea that Shatavari for Menopause is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Shatavari for Menopause. The studies focus on other potential benefits of Shatavari, such as its anticancer and immune-boosting properties, but do not mention its impact on menopause symptoms. Therefore, there is no direct evidence from the provided information to suggest that Shatavari is an effective treatment for menopause. ^{1 2 3 4 5}

What safety data exists for Shatavari used in menopause treatment?

The safety data for Shatavari (Asparagus racemosus) primarily focuses on its chemical composition and pharmacological properties. Studies confirm the absence of the alkaloid asparagamine A in Shatavari, suggesting previous reports of its presence were due to misidentification with Stemona plants. Shatavari contains steroidal saponins like shatavarin IV, which have been quantified in various products. It is used in Ayurvedic medicine for its potential benefits, including immunomodulatory and anti-lipid peroxidation effects, but scientific proof for these uses is limited. No specific safety concerns are highlighted in the available data, but comprehensive clinical safety evaluations for menopause treatment are not detailed in the provided research. ^{1 3 5 6 7}

Is Shatavari a promising treatment for menopause?

Yes, Shatavari is a promising treatment for menopause. It is known for its benefits in boosting the immune system, supporting women's health, and having potential anticancer properties. Shatavari contains active compounds like shatavarin IV, which contribute to its effectiveness. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.

Eligibility Criteria

This trial is for women experiencing menopause with symptoms like hot flashes and depression. Participants should take a capsule daily after breakfast for 8 weeks, without changing their diet or exercise routines.

Inclusion Criteria

I am experiencing menopausal symptoms like hot flashes or insomnia.

Must have the ability and willingness to sign an informed consent and to comply with all study procedures

Body mass index 18-35 kg/m2

Exclusion Criteria

I do not have major health issues that could affect the study.

Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective

Patients with known hypersensitivity to Ashwagandha

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive one capsule of Shatavari, Shatavari + Ashwagandha, or Placebo daily for 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Shatavari
• Shatavari + Ashwagandha

Trial Overview The study tests the effectiveness of Shatavari alone or combined with Ashwagandha against a placebo in reducing menopausal symptoms. Women are randomly assigned to one of three groups in this double-blind study.

Participant Groups

Group I: Shatavari + Ashwagandha Experimental Treatment 1 Intervention

One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water.

Group II: Shatavari Experimental Treatment 1 Intervention

One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water.

Group III: Placebo Placebo Group 1 Intervention

One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water.

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Ixoreal Biomed Inc.

Collaborator

Trials

2

Recruited

100+

Findings from Research

A new HPLC/MSIMS method was developed to accurately measure shatavarin IV, a key active ingredient in Asparagus racemosus, across various forms of the plant, demonstrating high precision and accuracy in quantification.

This method can be utilized for quality control and standardization of products containing Asparagus racemosus, ensuring consistent levels of its beneficial compounds in dietary supplements and Ayurvedic medicines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPLC/tandem mass spectrometric studies on steroidal saponins: an example of quantitative determination of Shatavarin IV from dietary supplements containing Asparagus racemosus. Patil, D., Gautam, M., Gairola, S., et al.[2019]

Shatavarin IV, isolated from Asparagus racemosus, demonstrated potent cytotoxicity against various cancer cell lines (MCF-7, HT-29, A-498) in vitro, indicating its potential as an effective anticancer agent.

In vivo studies showed that oral administration of a shatavarin-rich fraction (AR-2B) significantly reduced tumor growth and improved hematological parameters in tumor-bearing mice, suggesting its efficacy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shatavarins (containing Shatavarin IV) with anticancer activity from the roots of Asparagus racemosus. Mitra, SK., Prakash, NS., Sundaram, R.[2023]

Analysis of health food products labeled as shatavari confirmed their origin as Asparagus racemosus through steroidal saponin profiling, ensuring their authenticity as a tonic for women.

The study found no evidence of the alkaloid asparagamine A in A. racemosus, suggesting that previous reports of its presence were likely due to misidentification of similar-looking Stemona plants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical analysis reveals the botanical origin of shatavari products and confirms the absence of alkaloid asparagamine A in Asparagus racemosus. Kumeta, Y., Maruyama, T., Wakana, D., et al.[2021]

The aqueous extract of Asparagus racemosus (Shatavari) significantly enhances T cell activation and increases both Th1 (IL-2, IFN-g) and Th2 (IL-4) cytokine levels, indicating its potential as an immunoadjuvant.

Treatment with Shatavari extract also led to higher antibody titres and delayed-type hypersensitivity (DTH) responses, demonstrating its effectiveness in boosting systemic immunity in sensitized animals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunomodulatory activity of Asparagus racemosus on systemic Th1/Th2 immunity: implications for immunoadjuvant potential. Gautam, M., Saha, S., Bani, S., et al.[2022]

A new high-performance liquid chromatography method was developed to accurately measure five key saponin glycosides in Asparagus racemosus, which is important for ensuring the quality of this medicinal plant used in Ayurvedic medicine.

The study found that saponin glycosides were mainly present in the roots of A. racemosus, with significant variations in their concentrations across different geographical locations, highlighting the need for consistent quality control in herbal therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of Saponins in Asparagus racemosus by HPLC-Q-TOF-MS/MS. Onlom, C., Nuengchamnong, N., Phrompittayarat, W., et al.[2019]

A new method using an immunoaffinity column successfully isolated compounds related to shatavarin IV from Asparagus racemosus root, achieving a high recovery rate of approximately 90% for shatavarin saponin glycosides.

The isolated extracts showed moderate protection against lipid peroxidation, but the specific shatavarin glycosides had weaker protective effects, indicating that their mechanism of action may not involve inhibiting carcinogenesis through lipid peroxidation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunoaffinity Knockout of Saponin Glycosides from Asparagus racemosus to Assess Anti-lipid Peroxidation. Onlom, C., Phrompittayarat, W., Putalun, W., et al.[2018]

Asparagus racemosus (Shatavari) has been traditionally used in Ayurveda for various health issues, including gastric ulcers and as a galactogogue, but scientific evidence supporting these uses is limited.

Recent studies have shown that both alcoholic and water extracts of A. racemosus may have beneficial effects, including promoting milk production, protecting the liver, and enhancing immune function, indicating potential therapeutic properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asparagus racemosus--an update. Goyal, RK., Singh, J., Lal, H.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

HPLC/tandem mass spectrometric studies on steroidal saponins: an example of quantitative determination of Shatavarin IV from dietary supplements containing Asparagus racemosus. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Shatavarins (containing Shatavarin IV) with anticancer activity from the roots of Asparagus racemosus. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

Chemical analysis reveals the botanical origin of shatavari products and confirms the absence of alkaloid asparagamine A in Asparagus racemosus. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Immunomodulatory activity of Asparagus racemosus on systemic Th1/Th2 immunity: implications for immunoadjuvant potential. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Quantification of Saponins in Asparagus racemosus by HPLC-Q-TOF-MS/MS. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Immunoaffinity Knockout of Saponin Glycosides from Asparagus racemosus to Assess Anti-lipid Peroxidation. [2018]

7. India pubmed.ncbi.nlm.nih.gov

Asparagus racemosus--an update. [2022]