Shatavari Root Extract for Hot Flashes

Overseen By Stephanie L Hooper, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Jacksonville University

Must not be taking: Hormone therapy

Disqualifiers: Significant comorbidities, others

Compensation: Varies

Number of Visits: 2

Duration: 30 days

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are currently using hormone therapy or other medications known to affect hot flashes, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Shatavari Root Extract for hot flashes?

While there is no direct research on Shatavari Root Extract for hot flashes, other herbal treatments like Cimicifuga racemosa (black cohosh) and combinations of herbs such as Nigella sativa and Vitex agnus-castus have shown effectiveness in reducing menopausal symptoms like hot flashes. This suggests that herbal treatments can be beneficial for managing these symptoms. ^{1 2 3 4 5}

How does Shatavari Root Extract treatment for hot flashes differ from other treatments?

Shatavari Root Extract is unique because it is a natural herbal remedy, unlike hormone therapy which can have significant side effects. It may offer a plant-based alternative with potentially fewer risks, although more research is needed to confirm its effectiveness and safety for hot flashes. ^{1 2 4 6 7}

What is the purpose of this trial?

The goal of this clinical trial is to learn if a daily nutritional supplement can reduce hot flashes and other menopausal symptoms in postmenopausal women. The main questions this study aims to answer are: Does the supplement reduce the number and severity of daily hot flashes? Does it improve other common menopausal symptoms? Researchers will compare the supplement to a placebo (a look-alike capsule with no active ingredients) to see if it helps manage symptoms during menopause. Participants will: Take either the supplement or a placebo daily for 30 days Track their hot flashes each day using a short online survey Complete a symptom questionnaire at the beginning and end of the study This study is for women ages 40-60 who have been postmenopausal for at least one year and currently experience bothersome hot flashes.

Research Team

Heather A Hausenblas, PhD

Principal Investigator

Jacksonville University

Eligibility Criteria

This trial is for postmenopausal women aged 40-60 who have been experiencing menopause for at least a year and currently suffer from bothersome hot flashes. Women using hormone therapy or other medications affecting hot flashes, or those with significant health issues that could impact participation, are not eligible.

Inclusion Criteria

Menopause Rating Scale score: (a) GE 14 and (b) score of 3 or 4 (severe to very severe) for hot flashes (Blumel et al., 2018)

I am a woman aged between 40 and 60.

Exclusion Criteria

Significant comorbidities that may interfere with study participation

I am currently using hormone therapy or medications that can cause hot flashes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take either the supplement or a placebo daily for 30 days and track their hot flashes using a short online survey

30 days

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Shatavari Root Extract

Trial Overview The study tests if Shatavari Root Extract capsules can reduce the number and severity of daily hot flashes and improve other menopausal symptoms compared to a placebo. Participants will take the supplement or placebo for 30 days and track their symptoms through surveys.

Participant Groups

Group I: Supplement Group Active Control 1 Intervention

Group II: Placebo Group: Sugar pill Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Jacksonville University

Lead Sponsor

Trials

4

Recruited

200+

References

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

Evaluation of the effect of Silybum marianum extract on menopausal symptoms: A randomized, double-blind placebo-controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of a combination of Nigella sativa and Vitex agnus-castus with citalopram on healthy menopausal women with hot flashes: results from a subpopulation analysis. [2022]

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

Therapeutic efficacy and safety of Cimicifuga racemosa for gynecologic disorders. [2005]

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

Estro G-100 herbal extract and hot flashes in postmenopausal women: A randomized double-blinded controlled trial. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Fennel-Valerian Extract on Hot Flashes and Sleep Disorders in Postmenopausal Women: A Randomized Trial. [2023]

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

Effects of Chicory and Fumitory on Hot Flashes Among Breast Cancer Survivors: A Randomized, Double-Blind Placebo-Controlled Trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Evidence-Based Combination of Plant Extracts with Multitarget Mechanisms of Action for the Elimination of Hot Flashes during Menopause. [2022]