Shatavari Root Extract for Premenstrual Syndrome

Overseen By Dr. John Ademola

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Glucocorticoids, Anticonvulsants, Methotrexate

Disqualifiers: Pregnancy, Irregular menstrual cycles, Substance abuse, 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 examines whether Shatavari root extract can reduce symptoms of premenstrual syndrome (PMS), such as mood swings, tiredness, and stomach discomfort. Participants will take either the Shatavari extract or a placebo (a pill with no active ingredients) for 12 weeks to determine if the extract makes a difference. The study will also assess stress and sleep quality. Women with mild to moderate PMS who have regular periods and are not currently using herbal extracts or hormone therapy may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to understanding the potential benefits of a natural remedy for PMS.

Do I need to stop my current medications for this 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. Studies have found it well-tolerated for various women's health issues. In research on menopausal symptoms, participants reported few side effects with Shatavari extract. No serious adverse events occurred, and it was considered safe compared to a placebo. This suggests that for those considering a trial for premenstrual syndrome, the extract is likely safe and well-tolerated. However, as with any treatment, monitoring for side effects is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PMS?

Shatavari Root Extract is unique because it uses a natural herbal remedy, specifically Asparagus racemosus, to address premenstrual syndrome (PMS). Unlike conventional treatments for PMS, which often include hormonal therapies or antidepressants, Shatavari Root Extract offers a plant-based alternative that may have fewer side effects. Researchers are excited about this treatment because it taps into traditional medicine's potential and could provide a more holistic option for those seeking relief from PMS symptoms.

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

Studies have shown that Shatavari root extract may alleviate symptoms of premenstrual syndrome (PMS). Research indicates it can improve mood swings, reduce tiredness, and aid sleep issues. In one study, women taking Shatavari reported fewer mood problems and better sleep. The extract is also known for balancing hormones, which can help manage PMS. Additionally, Shatavari is considered safe and well-tolerated by most people. This trial will evaluate Shatavari root extract as an experimental treatment, with participants receiving either the extract or a placebo. These findings suggest that Shatavari root extract might be an effective natural option for managing PMS. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for women aged 18-40 with mild to moderate PMS, regular menstrual cycles, and a BMI between 18-35. Participants must be generally healthy, not pregnant, have intact uterus and ovaries, and able to follow study procedures. Those with severe PMS/PMDD or major health issues cannot join.

Inclusion Criteria

I am a woman with mild to moderate PMS confirmed by a symptom diary.

PSST scores consistent with PMS and not meeting criteria for severe PMS or PMDD

Body mass index 18-35 kg/m2

Exclusion Criteria

My periods have been irregular or I have missed two or more cycles in the past year.

Participants with demonstrated inability to comply with study procedures or follow-up visits

Participants with present active medical, surgical, and gynaecological problems

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 once daily 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 compares Shatavari root extract (300 mg daily) versus a placebo capsule over 12 weeks in women with PMS. Participants are randomly assigned to either group. The trial measures changes in PMS symptoms, stress levels, sleep quality, and overall well-being.

How Is the Trial Designed?

Group I: Shatavari Root Extract Experimental Treatment 1 Intervention

Participants assigned to this arm will receive Shatavari (Asparagus racemosus) root extract capsules at a dose of 300 mg taken orally once daily for 12 weeks.

Group II: Placebo (Inactive capsule) Placebo Group 1 Intervention

Participants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily 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.

ctv.veeva.com

ctv.veeva.com/study/efficacy-and-safety-of-shatavari-root-extract-for-premenstrual-syndrome-in-women

Efficacy and Safety of Shatavari Root Extract for Premenstrual ...

Traditional use and emerging scientific evidence suggest that Shatavari may be beneficial in alleviating mood disturbances, fatigue, sleep ...

3.

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 ...

4.

frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2026.1769773/full

Efficacy and safety of Shatavari root extract in women with ...

(2010) reported that Shatavari, in combination with other Ayurvedic herbs, significantly reduced PCOS symptoms by decreasing excessive body hair, reducing the ...

5.

tandfonline.com

tandfonline.com/doi/full/10.2147/IJWH.S561213

Effects of Shatavari (Asparagus racemosus) Root Extract ...

Conclusion. Shatavari root extract is considered a safe, effective, and well-tolerated treatment for improving women's sexual health and well-being. In addition ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07441109

Shatavari Root Extract for Perimenopausal Symptoms

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