Effect of ayurvedic drug KAL-10 on lowering hyperglycemic in subjects with diabetes: A Randomized Placebo Controlled trial.

Metabolic syndrome is defined as a group of factors that when present in an individual can lead to coronary heart disease, stroke and or Type II Diabetes.  The two main risk factors include increased weight and insulin resistance.  Other contributing factors including genetic history, age, hormone changes as well as lack of exercise.  Control of body weight and reduction of sugars thus plays an important role for in the treatment of metabolic disorder and the prevention of Type II diabetes and heart disease.

KAL-10 and KAL-10 Plus are Ayurvedic formulations which are designed to treat metabolic syndrome such as Type II Diabetes. KAL-10 is defined as purely herbal preparation.  KAL-10 Plus is defined as KAL-10 containing microgram quantities of mineral and amino acids.  These formulations contain Ayurvedic herbs prepared by a proprietary process to enhanced efficacy.

This study is a Randomized, Placebo Controlled,parallel group, single center monotherapy trial comparing the efficacy ofKAL-10 at 600 mg and KAL-10 Plus 650 mg twice daily for 12 weeks in patientswith type-II diabetes that will be conducted in Banaras Hindu University,India. The primary outcome measures will be to monitor Fasting Blood Sugar level,postprandial blood glucose level and HbA1c level reduction, in addition to improvement in insulin sensitivity, reduction in c-peptide levels and reduction in total triglycerides at 12 weeks. The secondary outcome will be to observe the improvement in lipidprofile. Comparator agent will be aplacebo.