Actively Recruiting
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
Led by SF Research Institute, Inc. · Updated on 2024-12-04
51
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
S
SF Research Institute, Inc.
Lead Sponsor
I
Ixoreal Biomed Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 45 to 65 years with intact uterus and ovaries
- Irregular menstrual cycles in the past 12 months with cycle changes over 7 days or at least 2 missed cycles, or menopause for at least 60 days
- Experiencing menopausal symptoms such as hot flashes, insomnia, migraine, or easy irritation
- Body mass index between 18 and 35 kg/m2
- Provided written informed consent and understand the study
- Able to read and write in English or another local language
- No plans to start new treatments during the study period
- Willing and able to comply with all study procedures
You will not qualify if you...
- Use of any herbal extracts within 3 months before study entry
- Hormone replacement therapy for more than 3 months
- Active medical, surgical, or gynecological problems
- History of alcohol, tobacco dependence, or substance abuse
- Previous bilateral ovariectomy
- History of breast or cervical cancer
- Taking medications affecting bone metabolism, such as glucocorticoids, anticonvulsants, or methotrexate
- Major cardiovascular, gastrointestinal, liver, neurological, endocrine, hematologic, or systemic diseases
- Mental conditions impairing understanding of the study
- Poor compliance or uncooperative attitude
- Unable to attend follow-up visits
- Any other medical condition interfering with study objectives
- Known allergy to Ashwagandha
- Participation in other clinical trials within the past 3 months
- Any clinical condition preventing safe participation according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
SF Research Institute, Inc.
San Francisco, California, United States, 94127
Actively Recruiting
Research Team
K
Khaleeq Rehman
CONTACT
J
John Ademola
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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