Effect of virgin coconut oil as a dietary supplement on lipid profile and oxidative stress in dyslipidemic individuals with low high density lipoproteins [ HDL].A 6 months follow up study in patients with and without coronary artery disease. - VCO study

COCONUT DEVELOPMENT BOARD0 个研究点目标入组 100 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。

•INCLUSION FOR CAD PATIENTS
•1.MALE/FEMALE OF 18 YEARS OF AGE.
•2SIGNIFICANT CAD IN AT LEAST ONE OF THE EPICARDIAL CORONARY ARTER CONFIRMED BY ANGIOGRAPHY.
•3.PREVIOUS MI OR ACUTE CORONARY SYNDROME NOT LESS THAN 3 MONTHS DURATION.
•4.OBJECTIVE EVIDENCE OF MYOCARDIAL ISCHEMIA WITH SYMPTOMS ON TRATMENT
•5.MDCT EVIDENCE OF CAD
•6.PATHOLOGICAL Q WAVES IN ECG AND OR RWMA IN ECHO
•7.LOW HDL <40 mg/dL IN MALES AND <50 mg/dL IN FEMALES.
•8SUBJECTS WILLING TO COMPLY WITH ALL FOLLOW-UP VISITS.
•9.SUBJECTS SIGNED AND RECEIVED COPY OF INFORMED CONSENT FOR MAIN TRIAL.
•INCLUSION FOR NON-CAD PATIENTS
•1.LOW HDL <40 mg/dL IN MALES AND <50 mg/dL IN FEMALES.
•2.SUBJECTS WILLING TO COMPLY WITH ALL FOLLOW-UP VISITS.
•3.SUBJECTS SIGNED AND RECEIVED COPY OF INFORMED CONSENT FOR MAIN TRIAL.

•EXCLUSION CRITERIA FOR CAD AND NON-CAD SUBJECTS
•1.UNTREATED HYPOTHYROIDISM AND UNCONTROLLED DIABETES MELLITUS
•2.PREEXISTING MAL ABSORPTION SYNDROME
•3.SEVERE CONGESTIVE HEART FAILURE AT THE TIME OF ENROLLEMENT.
•4.DIETARY PATTERN/DOMESTIC DIETETIC ENVIRONMENT, UNSUITABLE FOR TRIAL DESIGN.
•5.ABNORMAL RENAL FUNCTION WITH CREATININ GREATER THAN 2.0 Mg/dl & OR CREATININE CLEARENCE < 30ml/m.
•6.SGOT/SGPT GREATER THAN 3TIMES THE REFERENCE RAGE AT THE ENTRY.
•7.EXTRA CARDIAC ILLNESS THAT IS EXPECTED TO LIMIT SURVIVAL TO LESS THAN 2 YEARS.
•8.PATIENT ON MEDICATIONS THAT AFFECT ENDPOINTS OF THE STUDY
•9.PREGNANCY OR WOMEN OF CHILD BEARING POTENTIAL WITH INADEQUATE CONTRACEPTION
•10.CONCURRENT ENROLMENT IN ANOTHER CLINICAL TRIAL.

发起方

COCONUT DEVELOPMENT BOARD