Effect of Emblica officinalis,clopidogrel and ecosprin on platelet aggregation in patients with type II diabetes mellitus.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Diabetes Mellitus patients
- Registration Number
- CTRI/2013/07/003810
- Lead Sponsor
- AYUSH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Patients of either gender between 30-70 yrs, on stable dose of anti-diabetic medication (taking Metformin alone in dose between 1000-2500mg per day or in combination with glimiperide maximum 4 mg per day) as prescribed by the physician over past 8 weeks prior to screening visit and having HbA1c between 6.5-8% were enrolled in the study.
Exclusion Criteria
To avoid factors known to affect antiplatelet activity, the following exclusion criteria were applied: severe uncontrolled hyperglycemia, uncontrolled hypertension, cardiac arrhythmia, congestive heart failure, and evidence of hepatic and renal impairment or any other serious chronic disease requiring active treatment. Subjects hypersensitive to the study drugs were also excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy measure is to detect any significant change in platelet aggregation from baseline on administration of single and multiple doses of Phyllanthus emblica, clopidogrel and ecosprin and with combinations.Timepoint: At baseline and Post treatment.
- Secondary Outcome Measures
Name Time Method Secondary objective was to detect any changes in coagulation, hemodynamic parameters and adverse effects profile.Timepoint: At baseline and Posttreatment.