A clinical study to evaluate the effect of RoseFit on weight management in overweight subjects.
- Registration Number
- CTRI/2019/10/021584
- Lead Sponsor
- Vidya Herbs P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Overweight Subject: BMI >= 25.00 to < 30 kg/m2
2.Subject willing to adhere with their routine diet and exercise regimen throughout the study
3.Must be willing and able to give informed consent and comply with the study procedures
1Subjects suffering from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain six months prior to screening.
2Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Praderâ??Willi syndrome).
3Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months
4Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease);
5Subjects allergic to herbal products or any component of the study product
6Known HIV or Hepatitis B positive or any other immuno-compromised state
7History of Chronic metabolic disease, Psychiatric illness,Drug abuse, smoking abuse/addiction to alcohol, Bariatric surgery
Eating disorder such as bulimia or binge eating Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery, History of any major surgery
8Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
9Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body weight and BMI from baseline to end of the study (EOS) <br/ ><br> <br/ ><br>Change in body composition and fat distribution (assessed by DEXA) from baseline to EOS-body fat % and lean mass/fat mass ratioTimepoint: Day 0, Day 28, Day 56, Day 84
- Secondary Outcome Measures
Name Time Method Changes in Appetite biomarkers ,Visual Analog Scale Scores (VAS) for appetite ,Lipid profile and OGTT levels from baseline to EOSTimepoint: Day 0, Day 28, Day 56, Day 84