CTRI/2016/07/007067
Completed
N/A
Clinical study to evaluate the safety and efficacy of Herbal formulation for Obesity [HFO-O2] in overweight individuals
Baidyanath Bhavan Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Baidyanath Bhavan Pvt Ltd
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Overweight individuals (Body Mass Index between 25\-30\) with controlled co\-morbid dyslipidemia and/or hypertension and/or type 1 or type 2 diabetes
- •2\.Stable body weight (less than 5 kg self\-reported change during the previous 3 months)
- •3\.Age between 18 years and 60 years
- •4\.Individuals found compliant based on the Million Behavioural Medicine Diagnostic (MBMD)
- •5\.Willing to give Informed consent before any trial\-related activity takes place
Exclusion Criteria
- •1\.Known case of endocrinological disorders such as hyper/hypo thyroidism, Poly Cystic Ovarian Syndrome (PCOS)
- •2\.History of use one month before screening /currently using Allopathic or Ayurvedic medicines that may cause significant weight gain
- •3\.History of use one month before screening /currently using dietary supplements, over\-the\-counter medications or below mentioned Allopathic /Ayurvedic medicines for weight loss
- •4\.Current participation (past one month) in an organized weight reduction program
- •5\.Participants with a history of major depressive or other severe psychiatric disorders or an eating disorder \[judged by frequency and quantity of food]
- •6\.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator
- •7\.Pregnant or lactating females
Outcomes
Primary Outcomes
Not specified
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