A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIPHALADI KASHAYAM ON MICROALBUMINURIA LEVELS IN TYPE II DIABETES MELLITUS (MADHUMEHA)

India ranks top amongst diabetic sufferers. 8.5% of adults aged 18 years and older had Diabetes mellitus**.** Indian prevalence of diabetic nephropathy ranges from 0.9% to 62%. 10 years after diagnosis of DM the prevalence rate is 25%. In Chennai Urban Rural Epidemiology Study (CURES) people with a history of diabetes had a higher prevalence rate of microalbuminuria and Diabetic Nephropathy.In the survey of National Health and Nutrition Examination Survey (NHANES) and Kidney Early Evaluation Program only 9% of patient were aware of Diabetic Nephropathy and DKD (Diabetic Kidney Disease). A 12 years observational study reported that 44% of people with Type 2 DM developed proteinuria during follow up. Prameha is a disease involving Tridosha as well as all the Dhatus such as Meda, Rasa, Rakta, Mamsa, Vasa, Lasika, Majja, Shukra and Ojas (except Asthi Dhatu). Mainly Kapha Dosha and Meda Dhatu involves in the Samprapti of Prameha. If Prameha is untreated for long period of time it converts in to Madhumeha. Type II DM caused by insulin antagonism can be correlated with Avaran Janya Madhumeha. Microalbuminuria pathology starts with glycation of efferent arteriole. In samprapti of Prameha,Dushti of Kapha dosha leads to all Dhatu Dushti, Bahu Drava Kapha afflicts Meda dhatu. Kapha along with Meda Dhatu creates Avaran and develops Dhatu Shaithilya. Therefore glycation can be compared with Kapha and Meda janya Avaran.In Contemporary medicine Antihypertensive drugs are employed for treatment of microalbuminuria therefore patient should depend on both Anti-hypertensive and Anti-diabetic drugs. Here we are exploring single medication which target both diabetes as well as Microalbuminuria. According to the Study,the diabetic rats treated with Aragwadadi Kashayam at the dose level 200 and 400 mg/kg showed significant (p<0.001) decrease in Microalbuminuria levels,FBS, PPBS.A study concluded that a significant improvement was observed in Microalbuminuria level,fasting blood sugar level and post prandial glycemic level, and reported reduction in excessive urination of patients treated with Aragwadhadi kashayam.Aragwadhadi Kashayam is much effective in improving kidney function and preventing progression of diabetic nephropathy.Various formulation have been described in ayurveda classics which are having effect on Madhumeha and Triphaladi Kashayam is one of them.For treatment of microalbuminuria and Avaranjanya Madhumeha drug should have the properties of Kapha Medo Haram ,Kleda shoshanam, Agnideepan, Amapachana and Rukshanam. Triphaladi Kashayam is a formulation which contains Triphala (Amalaki,Vibhitaki, Haritaki) ,Aragwadha and Draksha having all this properties.So it is hypothesized that it will act in breaking down the samprapti of madhumeha and microalbuminuria.

Hence this work entitled "A RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIPHALADI KASHAYAM ON MICROALBUMINURIA LEVELS IN TYPE II DIABETES MELLITUS*(MADHUMEHA*” is planned.