Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
Eligible age
45–55 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
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About this study
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. 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 shatavari for treatment of menopausal symptoms in women.
Sponsor: SF Research Institute, Inc.
You may qualify if…
- ✓ 1. Menopausal women aged 45 to 65 years with intact uterus and ovaries.
- ✓ 2. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
- ✓ 3. Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- ✓ 4. Body mass index 18-35 kg/m2
- ✓ 5. Subject who has given written informed consent to participate in the study and understand the nature of the study
- ✓ 6. Able to read and write in English or any other vernacular language
- ✓ 7. No plan to commence new treatments over the study period.
- ✓ 8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
You may not qualify if…
- ✕ 1. Participants taking any form of herbal extract in the last 3 months before study entry.
- ✕ 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- ✕ 3. Participants with Present active medical, surgical, and gynaecological problems.
- ✕ 4. Participants with a history of alcohol, tobacco dependence, or any substance abuse
- ✕ 5. Participants who had undergone bilateral ovariectomy
- ✕ 6. Participants with history of breast or cervical carcinoma
- ✕ 7. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
- ✕ 8. Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
Where it's recruiting
San Francisco
Source: ClinicalTrials.gov · NCT06716554 · last updated 2024-12-04