Clinical trial for Menopause
Official title Satavari and Ashoka for Menopause (SAM) Study
ClinicalTrials.gov ID: NCT07861295
What this study is testing
- What it's testing
- This 12-week clinical trial will evaluate how well it works and how safe it is of a daily oral supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms.
- Time commitment: about 12 weeks
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65, women only
You may be able to join if
- Females aged 40-65 years.
- Postmenopausal women in good overall health and fulfilling menopausal criteria set at the MRS score more than 5.
- people had experienced absence of regular menstrual cycle for at least 3 months.
- Willingness to sign consent, follow protocols and regimen intake, as well as maintain normal physical activity and follow study procedures.
You likely can't join if
- Not on Hormone Replacement Therapy (HRT) or had discontinued HRT at least 12 months before admission to the study.
- History of breast cancer,
- BMI ≥ 40mg/kg².
- Prior removal of both ovaries.
- Pregnancy, breastfeeding, or plans for pregnancy.
- History of breast or uterine cancer, including hyperplasia, endometrial carcinoma, or cervical neoplasia.
See the full eligibility criteria
- Females aged 40-65 years.
- Postmenopausal women in good overall health and fulfilling menopausal criteria set at the MRS score more than 5.
- people had experienced absence of regular menstrual cycle for at least 3 months.
- Willingness to sign consent, follow protocols and regimen intake, as well as maintain normal physical activity and follow study procedures.
- Not on Hormone Replacement Therapy (HRT) or had discontinued HRT at least 12 months before admission to the study.
- History of breast cancer,
- BMI ≥ 40mg/kg².
- Prior removal of both ovaries.
- Pregnancy, breastfeeding, or plans for pregnancy.
- History of breast or uterine cancer, including hyperplasia, endometrial carcinoma, or cervical neoplasia.
- Unstable medical conditions or clinically diagnosed depression requiring treatment.
- Self-reported drug or alcohol abuse.
- Allergy or sensitivity to herbal ingredients.
- Undiagnosed abnormal vaginal bleeding;
- A bilateral hysterectomy;
- History of chronic alcoholism,
- Medication hypersensitivity, or allergy to dietary supplement ingredients;
- Acute systemic infection or abnormal laboratory values.
- No antibiotics use in past 30 days.
- No regular probiotics use in past 30 days.
The study team makes the final eligibility decision.
Where it is enrolling
- New Port Richey, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 40 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Port Richey, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.