Health Condition 1: null- Obese male or female patients Health Condition 2: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Cyperus rotundus capsule containing Cyperus rotundus extract: One capsule to be taken orally for a period of 90 days
Control Intervention1: Placebo: One capsule to be taken orally for a
Sponsors
Sami labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 BMI between >= 30 to 40 Kg/m 2 Willing to come for regular follow -up visits 3 Able to give written informed consent 4 Initially self-report a physical activity of less than 30-90 minutes of moderate to vigorous physical activity per week
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 obesity (Cushingâ??s syndrome,Turnerâ??s syndrome, Prader willi syndrome) 3 Patients with evidence of malignancy 4 Patients with poorly controlled Diabetes Mellitus (HbA1c 10%) 5 Patients with poorly controlled Hypertension ( greater than 160 / 100 mm Hg) 6 Patients on prolonged ( greater than 6 weeks) medication with corticosteroids,antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study 7 Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 8 Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months 9 Symptomatic patient with clinical evidence of Heart failure 10 Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin,Alkaline Phosphatase (ALP)greater than 2.5 times upper normal limit) or Renal Disorders (defined as S. Creatinine greater than 1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study 11 History of HIV and other viral infections 12 Alcoholics and/or drug abusers 13 Prior surgical therapy for obesity 14 History of hypersensitivity to any of the herbal extracts or dietary supplement 15 Pregnant/lactating woman 16 Patients who have completed participation in any other clinical trial during the past six (03) months 17 Other modulators like diet control, gym and yoga 18 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 Decrease in waist circumference and waist:hip ratio 3 Decrease in Cholesterol,Triglycerides, LDL and VLDL values 4 Increase in HDL values 5 Photographs of the subjectsTimepoint: 1 Decrease in body weight and BMI(Screening,Day 15,Day 30,Day 60 and Day 90) 2 Decrease in waist circumference and waist:hip ratio(Day 0,Day 15,Day 30,Day 60 and Day 90) 3 Decrease in Cholesterol,Triglycerides, LDL and VLDL values(Screening and Day 90) 4 Increase in HDL values(Screening and Day 90) 5 Photographs of the subjects(Day 0 and Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse EventsTimepoint: Adverse Events (Day 15,Day 30,Day 60 and Day 90) | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
ClinWorld(P)Ltd.
Outcome results
None listed