Shatavari Root Extract for Hot Flashes

HA
SL
Overseen ByStephanie L Hooper, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Jacksonville University

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a daily supplement made from Shatavari root can reduce hot flashes and other menopause symptoms. Researchers will compare the supplement's effects to a placebo (a look-alike pill with no active ingredients) to determine its impact on managing these symptoms. Participants will take the supplement or placebo for 30 days and track their symptoms through online surveys. Women who have been postmenopausal for at least a year and experience bothersome hot flashes may be suitable candidates for this study. As an unphased trial, this study offers participants a chance to contribute to understanding new potential treatments for menopause symptoms.

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.

Is there any evidence suggesting that Shatavari Root Extract is likely to be safe for humans?

Research has shown that Shatavari root extract is safe and generally well-tolerated. Several studies have found no major side effects in people taking Shatavari. For instance, one study found no significant side effects in individuals using Shatavari for menopausal symptoms. Another study confirmed that Shatavari effectively manages symptoms like hot flashes. Overall, the evidence suggests that Shatavari root extract is a safe option for those considering it for menopause-related issues.12345

Why are researchers excited about this trial?

Unlike typical treatments for hot flashes, which often include hormone replacement therapy or medications like SSRIs, Shatavari Root Extract is derived from a natural source. Researchers are excited about this treatment because it offers a plant-based alternative that may have fewer side effects and a unique mechanism of action. Shatavari is believed to support hormonal balance and has been used traditionally in Ayurvedic medicine, which sets it apart from conventional synthetic options. This natural approach could provide relief for those seeking non-hormonal and holistic options for managing hot flashes.

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

Research has shown that Shatavari root extract can help reduce hot flashes in postmenopausal women. In this trial, participants in the Supplement Group will receive Shatavari root extract, while those in the Placebo Group will receive a sugar pill. Previous studies found that women taking Shatavari experienced fewer and less intense hot flashes compared to those taking a placebo. Specifically, one study found a noticeable improvement in hot flashes, along with changes in important hormones like estradiol. These findings suggest that Shatavari might be a helpful supplement for managing hot flashes and other symptoms of menopause.12367

Who Is on the Research Team?

HA

Heather A Hausenblas, PhD

Principal Investigator

Jacksonville University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Supplement GroupActive Control1 Intervention
Group II: Placebo Group: Sugar pillPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jacksonville University

Lead Sponsor

Trials
4
Recruited
200+

Citations

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, ...
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.
Efficacy and Safety of Shatavari (Asparagus racemosus) ...Hot flashes improved significantly more (p = 0.002) with SHT group. Estradiol (p = 0.003), Follicle Stimulating Hormone (p = 0.028), and T3 (p = ...
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.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38725785/
Efficacy and Safety of Shatavari Root Extract for the ...Results The study outcomes showed a positive and significant effect of the active test ingredient over the placebo in terms of reduction in hot ...
NCT06716554 | Efficacy and Safety of Shatavari for ...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 ...
Clinical study finds shatavari extract reduces hot flashes ...Overall, the researchers stated the extract was demonstrated to be a safe and effective intervention for the symptoms and regulation of hormones ...
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