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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Shatavari, an herbal treatment, in easing menopause symptoms such as hot flashes, insomnia, and irritability. The study includes three groups: one taking Shatavari, another taking Shatavari combined with Ashwagandha (another herbal treatment), and a third taking a placebo (a pill with no active ingredients). Women who have experienced menopause symptoms like irregular periods, hot flashes, or sleep problems may qualify. The goal is to determine if these herbs are safe and effective for managing menopause symptoms. As an unphased trial, this study offers a unique opportunity to contribute to the understanding of natural treatments for menopause symptoms.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found Shatavari root extract safe for treating menopause symptoms. Participants reported no major side effects, indicating good tolerance. Another study showed that combining Shatavari with Ashwagandha was also safe and effective for managing menopause symptoms. This combination caused no significant negative effects, making it a promising option. Overall, current research suggests both treatments are safe, with no major concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for menopause because they utilize natural herbal extracts, offering a potentially more holistic approach compared to standard hormone replacement therapies. Shatavari, known for its adaptogenic properties, is used to help balance hormones and manage stress, which could be beneficial for menopausal symptoms. The combination of Shatavari with Ashwagandha may enhance these effects, as Ashwagandha is renowned for its stress-reducing and mood-enhancing benefits. Unlike conventional treatments that may carry risks of side effects, these natural supplements could provide a safer alternative for managing menopause symptoms.

What evidence suggests that this trial's treatments could be effective for menopausal symptoms?

This trial will compare the effects of Shatavari alone, Shatavari combined with Ashwagandha, and a placebo on menopausal symptoms. Studies have shown that Shatavari root extract can significantly reduce symptoms like hot flashes. For example, one study found that women taking Shatavari experienced a 73% reduction in symptoms, while those on a placebo had only a 22.8% reduction. Research also indicates that combining Shatavari with Ashwagandha might offer even more relief for menopause symptoms. Additionally, another study found that this combination can help with other common postmenopausal issues, such as blood vessel problems and bone loss. Overall, these findings suggest that Shatavari, alone or with Ashwagandha, could effectively ease menopausal symptoms. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

Body mass index 18-35 kg/m2

Subject who has given written informed consent to participate in the study and understand the nature of the study

Able to read and write in English or any other vernacular language

Exclusion Criteria

I have been on hormone replacement therapy for over 3 months.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11079574/

Efficacy and Safety of Shatavari Root Extract for the ... The study outcomes showed a positive and significant effect of the active test ingredient over the placebo in terms of reduction in hot flashes, ...

2. tandfonline.com tandfonline.com/doi/full/10.2147/IJWH.S544267

Efficacy and Safety of Shatavari (Asparagus racemosus) ... Conclusion. Shatavari root extract may be an effective and safe natural intervention for the treatment of perimenopausal symptoms. Keywords:.

3. frontiersin.org frontiersin.org/journals/reproductive-health/articles/10.3389/frph.2025.1654503/full

Efficacy and Safety of Shatavari Root Extract (Asparagus ... Shatavari root extract was safe and effective; however, combined with Ashwagandha root extract demonstrated a promising option in managing ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06716554

NCT06716554 | Efficacy and Safety of Shatavari for ... Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study.

5. nutritionaloutlook.com nutritionaloutlook.com/view/clinical-study-finds-shatavari-extract-reduces-hot-flashes-and-night-sweats-in-perimenopausal-women

Clinical study finds shatavari extract reduces hot flashes ... Asparagus racemosus extract significantly reduced menopausal symptoms, with a 73% reduction in MRS scores for the 100 mg group compared to 22.8% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06716554

NCT06716554 | Efficacy and Safety of Shatavari for ... Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study.

7. researchgate.net researchgate.net/publication/379722461_Efficacy_and_Safety_of_Shatavari_Root_Extract_for_the_Management_of_Menopausal_Symptoms_A_Double-Blind_Multicenter_Randomized_Controlled_Trial

(PDF) Efficacy and Safety of Shatavari Root Extract for the ... The extract was well tolerated, with no significant side effects, confirming Shatavari as a promising natural choice for menopause symptom ...