A multi centric, double-blind, randomized, parallel, clinical study to evaluate the effect of daily consumption of a test formulation for management of cardiovascular risk factors in dyslipidemic adults

ITC Life Sciences and Technology Centre0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Male and female dyslipidemic subjects aged more than or equal to 18 and less than or equal to 65 years of age
•2.Appropriate BMI.
•3.Subjects with history of stable weight
•4.Should be positive for at least 3 CVD risk factors
•5.Subject willing to comply with diet control and exercise
•6.On stable antihypertensives drugs.
•7.Diabetic subject who is only on oral hypoglycemic drugs
•8.Must be willing to give written informed consent and comply with the study procedures
•9.Female subjects are required to be non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically
•10.Acceptable form of birth control, as determined by the investigator.
•11.Women of child-bearing potential (non-postmenopausal and
•12.Non-surgically sterilized) willing to undergo a urine pregnancy test
•13.Subject meeting all the laboratory parameters set forth to qualify to enroll in the study

•1.Subject with very high values of blood lipids and glucose.
•2.Type 1 diabetes mellitus or secondary diabetes mellitus
•3.History of coronary artery disease (CAD), Angina, tread mill test
•4.(TMT) positive for inducible ischemia
•5.Uncontrolled hypertension
•6.Subjects on medications which might alter blood lipid levels.
•7.Other therapies such as homeopathy / ayurveda etc for treating above mentioned conditions
•8.Subjects who are allergic to herbal products or any component of the study product
•9.Pregnant or lactating women
•10.Subject with any abnormal/altered absorption or digestion.
•11.Suffering from any condition which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion.
•12.Subject with deteriorating health status at the time of enrollment.
•13.Known HIV positive. (e.g., human immunodeficiency virus [HIV] infection) or any other immuno-compromised state by history
•14.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
•15.Abnormal LFT and RFT.
•16.Subject unwilling or unable to comply with the study procedures
•17.History of allergy to any component of the study product

发起方

ITC Life Sciences and Technology Centre