Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: PR/HC/17-18/003 capsules: 2 capsules twice a day before meal for three months
Control Intervention1: NIL: NIL
Sponsors
Aayush Healthcare
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and or female patients. 2 Age between 20 to 50 years. 3 BMI between 25 to 40 kg/m2. 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 obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome). 3 Patients with evidence of malignancy. 4 Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%). 5 Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg). 6 Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 7 Symptomatic patient with clinical evidence of Heart failure. 8 Patients 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), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study. 9 History of HIV and other viral infections. 10 Alcoholics and/or drug abusers. 11 Prior surgical therapy for obesity. 12 History of hypersensitivity to any of the herbal extracts or dietary supplement. 13 Pregnant / lactating woman. 14 Patients who have completed participation in any other clinical trial during the past six (06) months. 15 Any other condition which the Principal Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Body weight Reduction of BMI Improved anthropometric measurements (waist circumference, waist: hip ratio) Lipid profile Change in leptin & CRP level QOL Questionnaire Timepoint: Baseline, Day 30,Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Adverse events (AEs), frequency and severity. Changes in the vital parameters Timepoint: Baseline, Day 30,Day 60 and Day 90 | — |
Countries
India
Contacts
Public ContactPayal Gawali
Aayush Healthcare
Outcome results
None listed