Ashwagandha for Menopause

Overseen By Jessie Cavanaugh, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Nutraceuticals Research Institute

Must not be taking: Thyroid, Hypertensive, CNS depressants, others

Disqualifiers: Pregnancy, Hysterectomy, Liver disorder, 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 tests the effectiveness of two different ashwagandha extracts in alleviating menopause symptoms, such as hot flashes and hormone levels, compared to a placebo. Participants will take either a daily ashwagandha supplement or a placebo for 84 days. The researchers aim to determine if ashwagandha can effectively relieve menopause symptoms. Women who still have regular periods and experience hot flashes might be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to the understanding of natural remedies for menopause symptoms.

Will I have to stop taking my current medications?

Yes, if you are currently taking thyroid medications, blood pressure drugs, medications for the central nervous system, diabetes medications, benzodiazepines, or immunosuppressants, you will need to stop taking them at least 60 days before joining the study.

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

Research has shown that ashwagandha is generally safe for most people. The root and leaf extract can be used safely for up to three months. Common side effects include stomach upset and drowsiness, while serious problems are rare.

One study found that using the root extract for 12 months did not harm the liver or kidneys, suggesting it is safe for long-term use. However, some individuals have experienced skin issues like itching and burning, which resolved after discontinuing the supplement.

Overall, both extracts appear safe for most people, but consulting a healthcare provider before starting any new supplement is always wise. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using ashwagandha for menopause because it offers a natural alternative to hormone replacement therapy and other medications typically used to manage menopausal symptoms. Ashwagandha, a plant-based remedy, is known for its adaptogenic properties, which may help balance stress hormones and improve overall well-being. This treatment stands out because it uses active ingredients from ashwagandha roots and leaves, which are thought to enhance its effectiveness. Unlike synthetic drugs, ashwagandha is derived from a natural source, potentially offering a gentler option with fewer side effects.

What evidence suggests that ashwagandha extract could be effective for menopause?

Research has shown that ashwagandha root extract can help relieve mild to moderate menopause symptoms, such as hot flashes and mood swings. In this trial, one group of participants will take an ashwagandha root supplement, while another group will receive a combination of ashwagandha root and leaf extracts. Previous studies found that women who took ashwagandha experienced noticeable improvements in their symptoms compared to those who took a placebo. Ashwagandha may also improve sleep quality and reduce stress, common issues during menopause. Another study found that using both ashwagandha root and leaf extracts helped reduce menopause symptoms and improved overall well-being. These findings suggest that ashwagandha could be a promising option for managing menopause symptoms. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for women aged 40 to 55 experiencing menopause symptoms, who menstruate regularly and have certain hormone levels. They must not have liver, kidney, hormonal or heart issues, recent weight changes or allergies to the treatment components. Participants should agree to lifestyle guidelines and contraception use.

Inclusion Criteria

Agreement to adhere to Lifestyle Considerations throughout study duration

I am willing and able to follow all study requirements.

For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study

Exclusion Criteria

I have a liver, kidney, hormonal, or heart condition.

Amenorrhea

Consumes more than 8 alcoholic beverages in an average week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take one of two ashwagandha extracts or a placebo daily for 84 days

12 weeks

4 visits (in-person) on days 0, 28, 56, and 84

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ashwagandha Extract

Trial Overview The study tests two proprietary ashwagandha extracts against a placebo in reducing menopausal symptoms like hot flashes. It's randomized and double-blinded, meaning neither researchers nor participants know who receives the actual extract versus the placebo.

How Is the Trial Designed?

Group I: Plant Extract 2 Experimental Treatment 1 Intervention

Participants in this arm will take an ashwagandha root and leaf supplement each day for 84 days.

Group II: Plant Extract 1 Experimental Treatment 1 Intervention

Participants in this arm will take an ashwagandha root supplement each day for 84 days.

Group III: Placebo Placebo Group 1 Intervention

Participants in this arm will take an inert placebo each day for 84 days.

Who Is Running the Clinical Trial?

Nutraceuticals Research Institute

Lead Sponsor

Trials

19

Recruited

3,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07210229?aggFilters=status%3Anot

The Effectiveness of a Proprietary Ashwagandha Extract on ... The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on symptoms of menopause and hormone levels, as ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34553463/

A randomized, double-blind, placebo-controlled study These findings suggest that ashwagandha root extract can be a safe and effective option to relieve mild to moderate climacteric symptoms during perimenopause ...

3. e-jmm.org e-jmm.org/DOIx.php?id=10.6118/jmm.24025

A Randomized, Double-Blind, Placebo-Controlled Study Ashwagandha and Shatavari Extracts Dose-Dependently Reduce Menopause Symptoms, Vascular Dysfunction, and Bone Resorption in Postmenopausal ...

4. journals.cambridgemedia.com.au journals.cambridgemedia.com.au/download_file/10692/382

Is Withania somnifera (Ashwagandha) a safe and effective ... Results Findings indicate that WS can significantly improve vasomotor symptoms, psychological well-being, sleep quality, cognition, stress ...

5. nutraingredients.com nutraingredients.com/Article/2021/10/27/Ashwagandha-root-extract-shows-efficacy-for-menopausal-symptoms/

Ashwagandha root extract shows efficacy for menopausal ... For the 91 women who completed the study, the data showed that women in the ashwagandha group experienced statistically significant reductions ...

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Ashwagandha-HealthProfessional/

Ashwagandha: Is it helpful for stress, anxiety, or sleep? Ashwagandha appears to be well tolerated for up to about 3 months of use, but its long-term safety is not known. Common side effects (e.g., ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-953/ashwagandha

Ashwagandha - Uses, Side Effects, and More When applied to the skin: Lotion containing ashwagandha is possibly safe when used for up to 2 months. Pregnancy: It is likely unsafe to use ashwagandha when ...

8. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/ashwagandha

Ashwagandha Ashwagandha is used in Ayurvedic formulations for stress, strain, fatigue, pain, skin disease, diabetes, gastrointestinal disease, ...

9. medicalnewstoday.com medicalnewstoday.com/articles/ashwagandha-menopause

Ashwagandha for menopause: Benefits, risks, and safety Some small studies suggest ashwagandha may reduce hot flashes, but there are potential risks. Learn more about ashwagandha and menopause.