Health Condition 1: null- For weight management in adult male and/or female obese or over weight patients Health Condition 2: E66- Overweight and obesity
Conditions
Interventions
Intervention1: PterostilbeneGarcinolAnthocyanin: One capsule of Pterostilbene GarcinolAnthocyanin 600 mg twice a day for a period of 90 days(combination in 1:1:1 ratio).
Control Intervention1: Not App
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients. 2. Age between 20 to 65 years. 3. BMI between > 25 to 40 Kg/m 4. Willing to come for regular follow-up visits. 5. Able to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months. 2. Pathophysiologic / genetic syndromes associated with obesit y (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader willi syndrome). 3. Patients with evidence of malignancy. 4. Patients with poorly controlled Hypertension ( > 160/100 mm Hg). 5. Patients 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. 6. Symptomatic patient with clinical evidence of Heart failure. 7. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and /or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2.5 times upper normal limit or Renal Disorders (defined as Serum Creatinine > 1.2 mg/dL, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and /or Chronic Obstructive Pulmonary Disease [COPD], or any other condition that may jeopardize the study. 8. History of HIV and other viral infections. 9. Alcoholics and/or drug abusers. 10. Prior surgical therapy for obesity. 11. History of hypersensitivity to any of the herbal extracts or dietary supplement. 12. Pregnant / lactating woman. 13. Patients who participated in any other clinical trial during the past six (06) months. 14. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Decrease in body weight and BMI. 2. Change in leptin and adiponectin levels. 3. Change in DEXA analysis 4. Decrease in Total Cholesterol, LDL Cholesterol, VLDL Cholesterol and Triglyceride levels. 5. Increase in HDL levels. 6. Improved anthropometric measurements (waist circumference, waist: hip ratio). 7. Clinical Photographs (Comparison from Screening to Final). 8. ESR and Hs-CRP. 9. Changes in blood glucose values, if any.Timepoint: 1Body weight and BMI(Screening,Day30,Day60 & Day90) 2Leptin,adiponectin,ESR & Hs-CRP(Screening & Day90) 3DEXA analysis(Screening & Day90) 4Lipid Profile(Screening & Day90) 5Anthropometric measurements(Day0,Day30,Day60 & Day90) 6Clinical Photographs(Screening & Day90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any reports of adverse or serious adverse events 2. Abnormal vital signs 3. Abnormal lab investigationsTimepoint: Screening to Day 90 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
ClinWorld Private Limited
Outcome results
None listed