Health Condition 1: null- Diabetes Mellitus patients
Conditions
Interventions
Intervention1: CAPROS®: The test product CAPROS® used in the present study contains a highly standardized aqueous extract of Phyllanthus embilica OR Emblica officinalis, containing not less than 60
Sponsors
AYUSH
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary objective was to detect any changes in coagulation, hemodynamic parameters and adverse effects profile.Timepoint: At baseline and Posttreatment. | — |
Countries
India
Contacts
Public ContactDrP Usharani
Nizams Institute of Medical Sciences
Outcome results
None listed