None listed
Conditions
Interventions
Intervention1: RoseFit: Two times a day orally
in morning and night 30 minutes before breakfast and dinner for 84 days
Control Intervention1: Placebo: Two times a day orally
in morning and night 30 minutes before breakfast and dinner for 84 days
Sponsors
Vidya Herbs P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Overweight Subject: BMI >= 25.00 to 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
Exclusion criteria
Exclusion criteria: 1 Subjects suffering from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain six months prior to screening. 2 Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Praderâ??Willi syndrome). 3 Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months 4 Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease); 5 Subjects allergic to herbal products or any component of the study product 6 Known HIV or Hepatitis B positive or any other immuno-compromised state 7 History 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 8 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body weight and BMI from baseline to end of the study (EOS) 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed