Nishat Fatima1, Usharani Pingali2, N Muralidhar1. 1. Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, India. 2. Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, India. Electronic address: ushapingali@yahoo.com.
Abstract
BACKGROUND:Diabetes mellitus is associated with oxidative stress which impairs the platelet function. Phyllanthus emblica extract a rich source of vitamin C plays an important role in scavenging free radicals. The effect of vitamin C on platelet aggregation in healthy and coronary artery disease patients has been demonstrated. The present study attempts to study the pharmacodynamic interactions of P. emblica extract with clopidogrel and ecosprin. MATERIALS AND METHODS: This was a randomized open label crossover study of 10 type II diabetic patients. The dosage schedules were either single dose of 500 mg P. emblica extract or 75 mg clopidogrel or 75 mg ecosprin or 500 mg P. emblica+75 mg clopidogrel or 500 mg P. emblica+75 mg ecosprin. After single dose study and washout period, patients received either 500 mg P. emblica extract twice daily or 75 mg clopidogrel or 75 mg ecosprin once daily or combinations for 10 days. Platelet aggregation was measured at baseline and at 4h of treatment after single and multiple dose study along with recording of bleeding and clotting time. RESULTS: After single and multiple dose administration of the three treatments and with combinations there was statistically significant decrease of platelet aggregation compared to baseline. Further, the mean percent inhibition of platelet aggregation was significant, when compared between single and multiple doses of P. emblica. The bleeding and clotting time was prolonged with single and multiple dose administration of all treatments compared to baseline. All treatments were well tolerated. CONCLUSION: P. emblica extract demonstrated significant antiplatelet activity with both single and multiple dose administration.
RCT Entities:
BACKGROUND:Diabetes mellitus is associated with oxidative stress which impairs the platelet function. Phyllanthus emblica extract a rich source of vitamin C plays an important role in scavenging free radicals. The effect of vitamin C on platelet aggregation in healthy and coronary artery diseasepatients has been demonstrated. The present study attempts to study the pharmacodynamic interactions of P. emblica extract with clopidogrel and ecosprin. MATERIALS AND METHODS: This was a randomized open label crossover study of 10 type II diabeticpatients. The dosage schedules were either single dose of 500 mg P. emblica extract or 75 mg clopidogrel or 75 mg ecosprin or 500 mg P. emblica+75 mg clopidogrel or 500 mg P. emblica+75 mg ecosprin. After single dose study and washout period, patients received either 500 mg P. emblica extract twice daily or 75 mg clopidogrel or 75 mg ecosprin once daily or combinations for 10 days. Platelet aggregation was measured at baseline and at 4h of treatment after single and multiple dose study along with recording of bleeding and clotting time. RESULTS: After single and multiple dose administration of the three treatments and with combinations there was statistically significant decrease of platelet aggregation compared to baseline. Further, the mean percent inhibition of platelet aggregation was significant, when compared between single and multiple doses of P. emblica. The bleeding and clotting time was prolonged with single and multiple dose administration of all treatments compared to baseline. All treatments were well tolerated. CONCLUSION:P. emblica extract demonstrated significant antiplatelet activity with both single and multiple dose administration.
Authors: Maryam Gul; Zhi-Wei Liu; Roshina Rabail; Fatima Faheem; Noman Walayat; Asad Nawaz; Muhammad Asim Shabbir; Paulo E S Munekata; José M Lorenzo; Rana Muhammad Aadil Journal: Antioxidants (Basel) Date: 2022-04-22