A double blind placebo controlled clinical trial to evaluate the efficacy and safety of Shatavari in Menstrual irregularity
- Conditions
- Menstrual irregularity
- Registration Number
- CTRI/2011/06/001804
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Females abovethe age of 45 with postmenopausal symptoms like hot flashes, night sweats, dryitchy skin, sleep disturbances, irritability, joint pain, anxiety or depression and meeting the other inclusion/exclusion criteria will be eligible to participate in the study. Subjects will be given 1 caplet thrice daily of Shatavari caplet or placebo , based on the randomization for 3 months. Subjective and objective evaluation will be done. Assessment will be done on entry, at the endof 1stnd month and at the end of 3rd month.Adverse effects as volunteered by the patients will be noted in the CRFs.Information on each patient will be collected from their history, physicalexamination and laboratory investigations, and will be recorded on the CaseReport Form.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
Females above the age of 45 with postmenopausal symptoms like hot flashes, night sweats, dry itchy skin, sleep disturbances, irritability, joint pain, anxiety or depression will be included in the study.
Subjects suffering from serious life threatening disorders or participated in a similar study within past 1 month will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in post menopausal symptoms. 3 months
- Secondary Outcome Measures
Name Time Method Assessment of long term safety of Shatavari caplet. 3 months
Trial Locations
- Locations (1)
Shuvdeep Ayurved Medical College & Hospital
🇮🇳Indore, MADHYA PRADESH, India
Shuvdeep Ayurved Medical College & Hospital🇮🇳Indore, MADHYA PRADESH, IndiaDr PatkiPrincipal investigator08022169999dr.patki@himalayahealthcare.com