A CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VEGETABLE POWDER IN THE MANAGEMENT OF CARDIOVASCULAR RISK FACTORS.
Not Applicable
Completed
- Conditions
- Health Condition 1: I998- Other disorder of circulatory system
- Registration Number
- CTRI/2016/05/006977
- Lead Sponsor
- ITC Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 288
Inclusion Criteria
•Males and females of age group 18-60 years
•Patients with diabetes (FBS greater than or equal to 130 mg/dL , PPBS greater than or equal to 200 mg/dL)
•Obese patients with Body mass index 25 to 35 kg/m2.
•Patients prone to Cardiovascular disease (Triglycerides greater than or equal to 150 mg/dl)
•Subjects must understand risks and benefits of the protocol and be able to give informed consent along with audio video visual.
•Equal distribution of subjects receiving medication amongst the test and placebo arms
Exclusion Criteria
•History of thyroid diseases
•History of HIV positive patients
•Pregnant or lactating woman
•Cancer, smoking, alcohol drinking.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method