Suitability for Consumption of Chyawanprakash-A Herbal Formulation in Controlled Type II Diabetics-A Open Label Clinical Study

Abstract

Objective: Chyawanprakash, a Chyawanprash based proprietary Ayurvedic formulation in which conventional sugar and honey are replaced by permitted alternate sweeteners in diabetic population. Design: This was a randomized open label clinical study conducted across two study sites in Maharashtra (India). 121 male and female subjects in the age range of 18-70 years who were suffering from Type II Diabetes mellitus for more than one year and were stabilized on either exercise/diet regimen or oral hypoglycemic agents were recruited in the study and advised 1 teaspoonful of Chyawanprakash twice daily orally after meals for 90 days. They were advised to continue their anti-diabetic medicines under the supervision of the Investigator. Results were assessed basis pre and post treatment changes in glycosyated hemoglobin (HbA1c) and the Physician global assessment of overall safety. Clinical symptoms, laboratory parameters like blood sugar and insulin levels, microalbuminuria, liver and renal function tests, lipid profiles etc and changes in dose of oral hypoglycemic agents were also assessed. Results: Oral administration of Chyawanprakash in recommended dosage in controlled Type II diabetics did not show any safety concern which was evident by no statistically significant change in HbA1c levels and the clinical as well as laboratory parameters (blood sugar, microalbuminuria, liver and renal function tests, lipid profiles etc). 97% excellent safety was reported on the Physician’s global assessment of overall safety. Moreover, a statistically significant improvement was also observed in energy levels of subjects. Conclusion: Results concluded the suitability of Chyawanprakash in controlled Type II diabetics.