Bipha Drug Laboratories, Kottayam, a leading Ayurvedic drug manufacturer in Kerala, is claimed to have achieved a major breakthrough in herbal drug research for diabetes I & II, following successful clinical trials for the drug 'Rajanyamalakadi.'
Ajay George, Director, Bipha told Pharmabiz that the clinical trials to assess hypoglycaemic effects of the tablets were conducted in 43 patients over a period of 3 months at the Government Ayurveda College, Thrippunithura, Ernakulam. The results showed exciting results without any observable toxicity in diabetic patients. The patients were divided into six groups based on their age group and by Fasting Blood Sugar (FBS) levels.
Results showed 20 per cent reduction in FBS levels in all groups and 2 per cent reduction in glycosylated haemoglobin in almost all groups. Total cholesterol, LDL and triglycerides reduced by 25 per cent, and the HDL levels showed significant increase. Insulin production increased by 10 per cent in all groups, and albumin, SGOT, SGPT, urea and creatinine levels decreased significantly. The study also showed increase in insulin secretion in the control group.
He said Bipha has plans to continue the studies on a larger platform at some of the leading hospitals and research centres in India and abroad. The drug Rajanyamalakadi, which Bipha launched in the market about ten years ago, was subjected to advanced research and validation in the last two years following the exciting results. The revalidated drug is likely to be soft launched in the market within the next three months, besides pursuing further clinical studies to fine tune the product, said Ajay.Elaborating on the ongoing anti-diabetic drug research in Ayurveda, he said certain drugs reduce hepatic gluconeogenesis by normalizing hepatic functions.