The effect of powdered green tea enriched with epigallocatchin gallate (EGCG) on some clinical, electrophysiological, biochemical, inflammatory and antioxidant parameters in patients with coronary artery disease, a randomized, triple blind clinical trial

The effect of powdered green tea enriched with EGCG on some clinical, electrophysiological, biochemical, inflammatory and antioxidant parameters in patients with coronary artery disease

Clinical trial with community-based control and pragmatism-based control group, with parallel groups, triple blind, randomized

Patients who referred to the angiographic unit of Ali-Ibn Abitaleb hospital of Rafsanjan will randomly divided into two groups. In each group, patients will take capsules for 3 months. Electrophysiological, clinical, biochemical, anti-inflammatory and antioxidant variables will be evaluated at baseline and 3 months after the intervention.

Coronary artery stenosis based on Gensini's criteria, willingness to participate in the study and age 40 and above are inclusion criteria. Allergy to green tea or components, the use of any antioxidant supplement, daily green tea intake before and during the study, follow a special diet, participate in another study, alcohol consumption, Candidate for coronary artery bypass graft surgery and pregnancy, diseases such as Alzheimer's disease, schizophrenia, kidney, urinary tract and osteoporosis, unstable angina and arrhythmia are exclusion criteria.

In intervention group patients will use 500 mg capsules of green tea powder enriched with 88 mg of polyphenol total and 11.2 mg of EGCG twice a day for 3 months. In control group, cellulose is used as a placebo for capsules and will be used in the same way as the intervention group. Two capsules Manufacturing by Giah Essence Phytopharm Company.

re-admission, systolic and diastolic blood pressure, quality of life, serum Triglycerides , Low and high density lipoprotein , Cholesterol, blood sugar, total antioxidant capacity and Interleukin 10 serum, anthropocentric parameters, heart rate

Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as age and sex. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables.

Drug and placebo were delivered as drugs 1 and 2, and the researcher will blind to placebo or drug of capsules. The patient also will not know that he is in the drug group or placebo. The analyst will not know the groups and will perform the analysis as group 1 and 2.