Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Nyagrodhadi Ghanavati: 500mg tablet will be given orally, twice daily, before food, with warm water, for a duration of 90 days
Control Intervention1: Navaka Guggulu: 500mg tablet will b
Sponsors
National Institute of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with LDL-C >= 130(mg/dl) at the time of screening. 2. Subjects with BMI >=24 3. Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II. 2. Subjects with uncontrolled Hypothyroidism or Hyperthyroidism 3. Known cases of Severe/Chronic Hepatic or Renal disease 4. Known subject of any active malignancy. 5. Subjects giving history of significant cardiovascular event 6. Known case of Anorexia Nervosa or Bulimia nervosa 7. Chronic alcoholics / Alcohol Abuse 8. Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia. 9. Subjects X- ray chest showing any active lesion of tuberculosis 10. Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV. 11. Subjects using any other investigational drug within 1 month prior to recruitment 12. Known hypersensitivity to any of the ingredients used in study drug 13. Pregnant and Lactating females. 15. Subjects currently participating in any other Clinical study 16. Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigatorâ??s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in LDL-C level at the end of study 2.Change in body weight at the end of study Timepoint: Baseline, 6th Week, 12th Week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in LDL-C level at 6 weeks 2.Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC) and High Density Lipoprotein (HDL) at 6 weeks and 12 weeks. 3.Change in Body Weight, BMI, Waist circumference and Waist to hip ratio at 6 weeks and 12 weeks. Timepoint: Baseline, 6th Week, 12th Week | — |
Countries
India
Contacts
Public ContactDr Bhagya Ranjan Dash
NIA, JAIPUR, RAJASTHAN
Outcome results
None listed