A clinical trial to study the effect of Pomegranate (Anar)fruit extract capsule in patients with Myocardial Infarction(MI)
- Conditions
- Health Condition 1: null- Myocardial Infarction(MI) And Coronary Artery Disease(CAD)
- Registration Number
- CTRI/2013/02/003420
- Lead Sponsor
- ot Applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
I. Myocardial infarction as per signs and symptoms:
Chest pain (typically down the left arm or left side of the neck), shortness of breath, nausea, sweating, anxiety, palpitations. (Diagnosed by clinical staff from Department of Medicine, VCSGGIMS&R)
Confirmatory tests
I. E.C.G. with changes - Q and ST segment elevation of 1mm or more in two neighboring leads
II. Creatinin kinase MB (CK-MB) level more than the reference range
III. Troponin I Or Troponin T level more than the reference range
Exclusion Criteria
I.Patients with acute illness, pregnant, lactating, and postoperative patients.
II.Patients with CNS disorders, systemic chronic diseases like renal failure, chronic hepatic disease, poorly controlled diabetes, or congestive heart failure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oxidative stress and CAD are main cause for the MI. Natural Antioxidants and Polyphenols presents in Pomegranate fruit will provide the prognostic significance against the oxidative stress. There may by improvement in the disease condition, which may be confirmed by quantitative estimation of biochemical markers with pre and post Pomegranate fruit extract and placebo after one month.Timepoint: 1.Literature review- 1 month <br/ ><br>2.Protocol preparation- 1 month <br/ ><br>3.Drug development-4 months <br/ ><br>4.Drug trial-6 months <br/ ><br>5.Data compilation & publication-2 months.
- Secondary Outcome Measures
Name Time Method ADRs/AEs of Pomogrenate extract with other anti anginal drugs if anyTimepoint: one month