Health Condition 1: E660- Obesity due to excess calories
Conditions
Interventions
Intervention1: Cissus quadrangularis capsules: Each Capsule containing Cissus quadrangularis 300 mg. 300mg capsules once daily for 12 weeks
Control Intervention1: Placebo capsules: Placebo containing
Sponsors
Star Hi Herbs PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants between 19 and 60 years 2. Body mass index (BMI) between 25-32kg/m2 3. Willingness to participate in the study
Exclusion criteria
Exclusion criteria: 1. Age below 19 years and above 60 years. 2. Pregnant or lactating women 3. Body mass index (BMI) 32kg/m2 4. Those who are underweight reduction medication 5. Those who are taking dietary supplements which are related to weight control. 6. Participation in intense exercise programs 7. Medical conditions are known to affect serum lipids 8. A history of drug and alcohol abuse 9. Patients with uncontrolled hypertension (systolic > 160 mmHg and diastolic > 100 mmHg) 10. Patients with a fasting blood glucose of >=126 mg/dL or who are taking antidiabetic drugs 11. Abnormal TSH value 12. Creatine more than twice the upper limit of normal 13. AST, ALT more than 3 times the upper limit of normal 14. Those with food intake problems due to severe gastrointestinal disorders 15. Those with central nervous system disorders 16. Those who cannot exercise due to musculoskeletal disorders 17. A person who has participated in a commercial obesity program within the last three months. 18. A person who has participated in another clinical study or plans to participate within one month. 19. Those who have lost more than 5% of their weight within the last three months; 20. A person who is deemed inappropriate for testing by Project Director
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body fat mass & body fat change rate through DEXA analysis: DEXA (Dual Energy X-ray Absorptiometry)Timepoint: Change in Body fat mass & body fat change rate through DEXA analysis: DEXA (Dual Energy X-ray Absorptiometry) will be repeated on week 1 & week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body weight 2. Leptin & adiponectin 3. Waist circumference, HIP circumference, Reduce in the waist-hip ratio 4. BMI (Body mass index) 5. Lean mass through DEXA 6. Visceral fat area, subcutaneous fat area, total abdominal fat area Visceral/subcutaneous fat area ratio through CT 7. Blood lipid: Total cholesterol, HDL-cholesterol, LDLcholesterol, TriglycerideTimepoint: Change in Anthropometric measurements will be repeated on week 1, week 6 & week 12 and Change in CT, Leptin and adiponectin,Blood Lipid Profile will be repeated on week 1 and week 12. | — |
Countries
India
Contacts
Public ContactDr C T SADASHIVA
Department of Pharmacy Practice, Head Clinical Trials,Clinical Trial Centre
Outcome results
None listed