FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072972 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL STUDY TO FIND THE EFFECT OF TRIPHALADI KASHAYAM WITH INCREASED MICROALBUMINURIA LEVELS IN TYPE II DIABETES MELLITUS  
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIPHALADI KASHAYAM ON MICROALBUMINURIA LEVELS IN TYPE II DIABETES MELLITUS (MADHUMEHA)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Payal Durge  
Designation  Postgraduate Scholar (Dept. of Kayachikitsa) 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9284072554  
Fax    
Email  payaldurge001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vipin S G 
Designation  Associate Professor (Dept. of Kayachikitsa),SJSACH ,Chennai 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital  
Address  Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8547626217  
Fax    
Email  drvipinsg@sjsach.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vipin S G 
Designation  Associate Professor (Dept. of Kayachikitsa),SJSACH ,Chennai 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital  
Address  Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai


TAMIL NADU
600123
India 
Phone  8547626217  
Fax    
Email  drvipinsg@sjsach.org.in  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur TamilNadu India 600123 
 
Primary Sponsor  
Name  Payal Durge  
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Payal Durge  Sri Jayendra Saraswathi Ayurveda College and Hospital  Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai
Thiruvallur
TAMIL NADU 
9284072554

payaldurge001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Jayendra Saraswathi Ayurveda College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E112||Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi kashayam, Reference: Susrutha samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Aragwadadhi kashayam, Reference: Yogagrantham, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  H/O Type II Diabetes Mellitus
Microalbuminuria levels between 30 to 299 mg/dl
HbA1c more than 6.5% 
 
ExclusionCriteria 
Details  Patient with Age below 18 and above 75 years
Patient with H/O Type 1 DM
Type II DM on insulin therapy
Type II DM along with hypertension and under Anti-hypertensive Medication
Microalbuminuria levels more than 300 mg/dl
Pregnant and lactating mothers
Microalbuminuria induced due to other diseases – Pregnancy, CKD
Patient with other complication of DM–Ketoacidosis, Diabetic nephropathy
Any other Systemic illness 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Microalbuminuria levels



 
criteria will be assessed on 31st days



 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in FBS and PPBS levels
Reduction in symptoms like Prabhoot Mutrata
Pipasaadhikya
Kshudhaadhikya
Klama 
criteria will be assessed on 31st days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
Close