Shatavari Root Extract for Perimenopause

Overseen By Dr. John Ademola

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Herbal extracts, Hormone therapy

Disqualifiers: Pregnancy, Substance abuse, Cancer, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Shatavari root extract can ease symptoms related to perimenopause, such as hot flashes, mood swings, and sleep issues. Participants will take either the Shatavari extract or a placebo (a pill with no active ingredient) daily for 12 weeks. Researchers will track changes in symptoms, mood, and sleep quality, ensuring safety through regular check-ups. Women experiencing irregular periods and two or more perimenopausal symptoms, such as night sweats or breast tenderness, may be suitable for this trial. As an unphased trial, this study offers an opportunity to contribute to understanding how Shatavari might benefit women experiencing perimenopause.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like hormone replacement therapy or medications affecting bone metabolism. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Shatavari root extract is likely to be safe for humans?

Research has shown that Shatavari root extract is generally safe for treating perimenopause symptoms. Participants have tolerated it well in studies. For example, one study highlighted its positive effects on hormone balance and symptom relief without major side effects. Another study described Shatavari as a safe and effective option for improving women's health during menopause. Overall, Shatavari root extract appears to have a good safety record, with few reports of negative effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for perimenopause, which often include hormone replacement therapies, Shatavari Root Extract (SRI-81) is a plant-based alternative derived from Asparagus racemosus. Researchers are excited about this treatment because it offers a natural option that may alleviate symptoms with potentially fewer side effects. Shatavari is believed to work by balancing hormones naturally, which could be appealing for those seeking holistic approaches to managing perimenopausal symptoms.

What evidence suggests that Shatavari Root Extract might be an effective treatment for perimenopause?

Research has shown that Shatavari root extract, which participants in this trial may receive, can help reduce symptoms of perimenopause. One study found that individuals taking the extract reported a 73% drop in their symptom scores, experiencing fewer issues like hot flashes and night sweats. Shatavari also balances hormones, potentially improving mood and sleep. Studies confirm its safety and effectiveness, offering a natural way to relieve symptoms. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 40-45 with an intact uterus and ovaries who are experiencing perimenopausal symptoms like irregular periods, hot flashes, or mood swings. Participants must not have serious health issues, recent use of herbal extracts or hormone therapy, be pregnant, or have a history of cancer.

Inclusion Criteria

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

Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days

No plan to commence new treatments over the study period

Exclusion Criteria

Participants with present active medical, surgical, and gynaecological problems

I have had both of my ovaries surgically removed.

I have had breast or cervical cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Shatavari root extract or placebo for 12 weeks

12 weeks

4 visits (in-person) at Baseline, Week 4, Week 8, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shatavari Root Extract

Trial Overview

The study tests whether Shatavari root extract helps relieve perimenopausal symptoms compared to a placebo. Women will randomly receive either the extract or a dummy capsule for 12 weeks without knowing which one they get.

How Is the Trial Designed?

Group I: Shatavari Root Extract (SRI-81) 300 mg Experimental Treatment 1 Intervention

Participants will receive a standardized Shatavari (Asparagus racemosus) root extract capsule containing 300 mg, administered orally once daily after breakfast with water for 12 weeks.

Group II: Placebo Capsule (Starch) 300 mg Placebo Group 1 Intervention

Participants will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks.

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Ixoreal Biomed Private Limited

Industry Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12593836/

Efficacy and Safety of Shatavari (Asparagus racemosus) Root ...

Conclusion. Shatavari root extract may be an effective and safe natural intervention for the treatment of perimenopausal symptoms. Keywords: ...

2.

frontiersin.org

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

Efficacy and safety of Shatavari root extract (Asparagus ...

Shatavari acts as a primary rejuvenative herb for women, helps to regulate hormonal balance, improve reproductive health, and reduce menopausal ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07441109

Shatavari Root Extract for Perimenopausal Symptoms

Secondary outcomes include menopause-specific quality of life, hot flash interference, perceived stress, mood, sleep quality, and salivary cortisol measures.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41394012/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1T5FW5K6kI73iaYFcm6n6ILcuJDBKumLJYi5zjRCdcUGYRRQ1&fc=None&ff=20260303015256&v=2.19.0.post6+133c1fe

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 ...

5.

tandfonline.com

tandfonline.com/doi/abs/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:.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12695842/

Efficacy and safety of Shatavari root extract (Asparagus ... - PMC

Shatavari acts as a primary rejuvenative herb for women, helps to regulate hormonal balance, improve reproductive health, and reduce menopausal ...

7.

ctv.veeva.com

ctv.veeva.com/study/shatavari-root-extract-for-perimenopausal-symptoms

Shatavari Root Extract for Perimenopausal Symptoms

This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy and safety of a standardized Shatavari (Asparagus ...