Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Standardized Garcinol 20% 180mg tablet: one tablet b.i.d. after breakfast and dinner for 90 days
Control Intervention1: Placebo 180 mg: One tablet b.i.d. after breakfast and dinner for
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and/or female subjects aged between 21 to 55 years both inclusive. 2 BMI greater than or equal to 29 Kg/m2and less than or equal to 40 Kg/m2. 3 Willing to take up the walking exercise for a span of 30 minutes daily for 5 days in a week and follow the recommended diet throughout the study. 4 Subjects agree to maintain a diary on food consumption and exercise. 5 Able to give written informed consent. 6 Willing to come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1 Intake of prescribed drugs in Ayurveda, Homeopathy, Naturopathy, Allopathy etc. or prior surgery for obesity in the previous six months. 2 Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome,Turnerâ??s syndrome, Prader-Willi syndrome). 3 Alcoholics 4 Subjects with evidence of malignancy. 5 Subjects having history of diabetes (Type I or Type II); with the fasting blood glucose >=126 mg/dl and HbA1c > 6.5% 6 Subjects with history of clinically diagnosed Hypertension and with BP > 140 / 90 mm of Hg. 7 Subjects diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 mIU/L. 8 Subjects on lipid lowering drugs. 9 Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Pagetâ??s disease, joint fracture,acromegaly, fibromyalgia, Wilsons disease,Ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis. 10 Subjects having history of coagulopathies, cardiovascular diseases, congestive heart failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness, peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]. 11 Have been diagnosed with an eating disorder, such as anorexia nervosa, bulimia nervosa, binge eating disorder or nocturnal eating disorder. 12 History of any psychiatric disorders like schizophrenia or bipolar disorder. 13 Weight loss (±5%) in last 6 months. 14 Subjects on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 15 Subjects with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin,Alkaline Phosphatase (ALP) >2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL for females or >1.4 mg/dL for males and EGFR of 60 or less). 16 History of hypersensitivity to any of the herbal extracts or dietary supplement. 17 Pregnant / lactating woman. 18 Subjects who have completed participation in any other clinical trial during the last three months. 19 Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Mean change in measured body weightTimepoint: 1 Mean change in measured body weight (Baseline and Day90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Mean change in calculated BMI 2 Mean changes in Lipid profile. 3 Mean change in the glycaemic parameters. 4 Change in measured body weight. 5 Mean changes in obesity related serum biomarkers. 6 Mean change in waist circumference. 7 Mean change in waist to hip ratio. 8 Incidence and rate of adverse events. 9 Exploratory objective - Change in microbial gut flora.Timepoint: 1 Calculated BMI (Baseline and Day 90) 2 Lipid profile (Screening and Day 90). 3 Glycaemic parameters (Screening and Day 90). 4 Body weight (Day 30,Day 60 & Day 90 respectively) 5 Obesity related serum biomarkers (Baseline and Day 90). 6 Waist circumference (Baseline and Day 90) 7 Waist to hip ratio (Baseline and Day 90). 8 Incidence and rate of adverse events. 9 Exploratory objective - Change in microbial gut flora (Baseline and Day90). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld Private Limited
Outcome results
None listed