Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: (Subjects will be randomized to one of the ten groups as per computer generated randomization list after screening. All the Subjects in all the Groups will be advised to take oral medic
Sponsors
National Innovation Foundation NIF
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with LDL-C >= 130 at the time of screening, Subjects with BMI >=23, Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent
Exclusion criteria
Exclusion criteria: Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II, Subjects who have Diet with excess cholesterol, saturated fat or calories, Subjects with uncontrolled Hypothyroidism or Hyperthyroidism, Known cases of Severe/Chronic Hepatic or Renal disease, Known subject of any active malignancy, Subjects giving the history of significant cardiovascular event < 12 weeks prior to randomization, Known case of Anorexia Nervosa or Bulimia nervosa, Chronic alcoholics / Alcohol Abuse, Subjects ECG demonstrating any signs of uncontrolled arrhythmia or acute ischemia, Subjects X-ray chest showing any active lesion of tuberculosis, Subjects having known chronic, contagious infectious diseases, such as active tuberculosis Hepatitis B or C, or HIV, Subjects using any other investigational drug within 1 month prior to recruitment, Known hypersensitivity to any of the ingredients used in study drug, Pregnant and Lactating females, Subjects currently participating in any other clinical study, Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigatorâ??s judgment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| change in TG, HDL,TC,EQ-5D, lipid profile, overall efficacy, safety assesmentTimepoint: 6 weeks, 12 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Change in LDL-C level at the end of study (12 weeks), Change in body weight at the end of study (12 weeks) Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Pawan kumar Godatwar
National Institute of Ayurveda (Deemed To Be University)
Outcome results
None listed