RESUMO
As per Drug Controller General of India (DCGI), there are clear cut compensation guidelines for clinical trial participants in case of death and injury after amendment in schedule Y (Rule 122DAB - Compensation in case of injury or death during clinical trial). The purpose of these guidelines is to provide Severe Adverse Event (SAE) compensation calculation as well as determination of the ratio of amount in clinical trial injury.
RESUMO
To evaluate the safety and effectiveness of polyherbal powder (Sugaradik) in achieving glycaemic control in newly diagnosed type 2 diabetics. Methods: It was a randomised double blind placebo controlled study. Eighty newly diagnosed patients of type 2 diabetes were selected after meeting inclusion and exclusion criteria. Patients were randomly divided into two groups. One group received drug and other group received placebo bearing a distinctive code number. Anthropometric parameters and HbA1c were performed initially as well as after three months of treatment period. Fasting blood sugar and blood pressure were recorded weekly. Student’s ‘t’ test was applied as statistical tool. Results: After three months of treatment of polyherbal powder (Sugaradik) there was a significant improvement in systolic blood pressure (136.05±3.30 to 126.42±1.51 mmHg) and fasting blood sugar (233.03±8.81 to 136.16±4.96 mg/dl; p less than 0.001). There was a significant reduction in HbA1c (8.39±0.30 to 6.37±0.10 percent; p less than 0.001). No adverse effects were observed in this trial. Conclusion: Polyherbal preparation of ten classic herbs appears to be effective in controlling glycemia. Sugaradik seems to be a safe drug and an effective oral agent in the management of type 2 diabetes.