Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Stilbenoids: One capsule b.i.d. after breakfast and dinner for 90 days.
Control Intervention1: Placebo: One capsule b.i.d. after breakfast and dinner for 90 days.
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 29kg/m2 and less than or equal to ( 3 Self-reported lack of physical activity and lethargic life- style. 4 Willing to take up walking exercise for a span of 30 minutes daily for 5 days in a week. 5 Subjects willing to follow the recommended diet throughout the study. 6 Able to give written informed consent. 7 Willing to come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1 Intake of over the counter or prescribed Allopathic /Ayurvedic/ Homeopathic/Naturopathic weight loss medications, centrally acting appetite suppressants in the past three months. 2 Previous weight loss surgeries like bariatric surgery procedures (gastric bypass, sleeve gastrectomy, adjustable gastric band, biliopancreatic diversion with duodenal switch etc.). 3 On other modulators like special diet, diet control, gym and yoga. 4 Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader-Willi syndrome). 5 History of chronic smoking (more than 2 cigarettes a day). 6 Alcoholics. 7 Subjects with evidence of malignancy. 8 Subjects having history of diabetes (Type I or Type II), FBS >= 126 mg/dl and HbA1c > 6.5% 9 Subjects with history of clinically diagnosed Hypertension and with BP > 140/90 mm of Hg. 10 Subjects diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 mIU/L. 11 Subjects on lipid lowering drugs. 12 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. 13 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 Disorder [COPD]. 14 Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder or nocturnal eating disorder. 15 History of severe psychiatric disorders like schizophrenia or bipolar disorder. 16 Weight loss (±5%) in last 6 months. 17 Subjects on prolonged ( > 4 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 18 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). 19 History of hypersensitivity to any of the herbal extracts or dietary supplement. 20 Pregnant/lactating woman and females with history of PCOS will not be included in the study. 21 Subjects who have completed participation in any other clinical trial during the last three months. 22 Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Decrease in measured body weight and calculated Body Mass Index. 2 Decrease in waist circumference, hip circumference and waist: hip ratio (anthropometric measurements).Timepoint: 1 Body weight and calculated Body Mass Index (Screening,Visit3,Visit4 & Visit5). 2 Waist circumference, hip circumference and waist: hip ratio (anthropometric measurements)(Baseline,Visit3,Visit4 & Visit5). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in Laboratory parameters. 2 Change in Leptin. 3 Adverse events.Timepoint: 1 Laboratory parameters(Screening & final visit). 2 Leptin (Baseline & final visit). 3 Adverse Event (Visit 3, Visit 4 and Final visit & telephonic follow up). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld Private Limited
Outcome results
None listed