A clinical study to evaluate the safety of cassia tora consumption in humans
- Registration Number
- CTRI/2014/11/005160
- Lead Sponsor
- Director
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
•Apparently healthy volunteers in the age range of 20-55 years
•Willing to provide written informed consent
•History of a cardiovascular event (myocardial infarction, angioplasty or coronary artery bypass grafting less than a year ago, unstable angina pectoris)
•Diabetes mellitus
•Uncorrected hypothyroidism
•Other metabolic endocrine disease
•Uncontrolled hypertension (diastolic blood pressure > 95 mm Hg)
•Active liver disease
•Severe gastrointestinal disease
•Acute inflammatory disease
•Severe kidney or other severe disease
•Any major surgery within the last year
•Use of systemic corticosteroids, anticoagulants, or lipid-lowering drugs
•Treatment within the previous 6 months with any medication that is known to affect lipid or lipoprotein levels (such as statins, fibric acid derivatives, bile acid sequestrants, ezetimibe, nicotinic acid, and ACE inhibitors)
•Use of anticoagulants and systemic corticosteroids
•Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of Cassia tora will be assessed by recording adverse events that occur during the course of the study. In addition, blood testing will be before, during and after treatment phase for complete blood count , sodium, potassium, chloride, blood urea nitrogen, creatinine, uric acid, alanine transaminase, gamma-glutamyl transferase, total bilirubin.Timepoint: Data will be captured upon recruitment and every three months interval ( 6 months drug and 6 months placebo with a washout period of one month in between placebo and drug).
- Secondary Outcome Measures
Name Time Method