FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/093957 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   STUDY TO EVALUATE COMBINED EFFECT OF NYGRODADI CHURNA AND ASNADI KASHAYA IN MADHUMEHA( TYPE 2 DIABETES) 
Scientific Title of Study   A THREE ARM CLINICAL STUDY TO EVALUATE THE INDIVIDUAL AND COMBINED EFFECT OF NYGRODADI CHURNA AND ASANADI KASHAYA IN THE MANAGEMENT OF MADHUMEHA VIS-A-VIS TYPE 2 DIABETES MELLITUS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anusha Soppimath 
Designation  Resident doctor 
Affiliation  Ramakrishna ayurvedic medical college 
Address  kayachikista department, Ramagondanahalli, yelahnaka, banglore

Bangalore
KARNATAKA
560064
India 
Phone  9739313404  
Fax    
Email  anushasoppimath62@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana C P 
Designation  HOD 
Affiliation  Ramakrishna ayuvedic medical college 
Address  kayachikista department, Ramagondanahalli, yelahnaka, banglore

Bangalore
KARNATAKA
560064
India 
Phone  9900063059  
Fax    
Email  aayurvedalaya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archana C P 
Designation  HOD 
Affiliation  Ramakrishna ayuvedic medical college 
Address  kayachikista department, Ramagondanahalli, yelahnaka, banglore


KARNATAKA
560064
India 
Phone  9900063059  
Fax    
Email  aayurvedalaya@gmail.com  
 
Source of Monetary or Material Support  
Ramakrishna Ayurvedic college kayachikista department 
 
Primary Sponsor  
Name  Ramakrishna ayurvedic medical college 
Address  kayachikista department, Ramagondanahalli, yelahanka, banglore-560064 
Type of Sponsor  Private medical college 
 
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 Anusha soppimath  Ramakrishna ayurvedic medical college  kayachikista department, Ramagondanahalli, Yelhanka, Bangalore
Bangalore
KARNATAKA 
9739313404

anushasoppimath62@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramakrishna ayurvedic medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: nygrodhadhi churna , Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: asanadi kashaya, Reference: bahaishijya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  fasting blood glucose level more than 110-180
postprandial blood sugar level more then 140-250
patient ready to sign informed consent
 
 
ExclusionCriteria 
Details  patient with insulin dependent diabetes mellitus
patient with complications of madhumeha or t2dm
diabeties with endocronities
drug or chemical induced dm
genetic symptoms including dm
suffering sever systemic diseases
patients with type 1 dm
blood sugar
fasting less greater than 180
post prandial sugar level more than 250
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to evalate combined action of drug nygrodadhi churna and asanadi kashya in madhumeha and t2dm  evaluation is done on 0th day 15 day and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate induvidal action of nygrodadhi churna and asanadhi kashaya  evaluation is done on 0th day 15th day 30th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   10/09/2026 
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="0"
Months="0"
Days="30" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  will be displayed with study

  6. For how long will this data be available start date provided 13-08-2025 and end date provided 13-10-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The word Prameha is derived from, Pra – means excess, Meha – ksharane - passing of urine. So Prameha  is  (passing  excessive  urine  which is turbid  in  color) prabhootha  avila  mootrata.  In Charaka Samhita  literature 20 types of Prameha are described which are in general characterized by  Prabhootmutrata . Mentioning about the causative factors of Madumeha ,Acharya Charak says it occurs due to- inactivity or lack of exercise, excessive sleep, excess use of milk, milk products like curd, use of gramya, audaka and anoop mansa, use of newly harvested cereals, use of jaggery and their derivatives, use of  kapha promoting things etc. Any of the twenty Prameha when left untreated is converted into Madhumeha (type 2 diabetes Mellitus) and patient passes large amount of sweet urine as madhu (glycosuria)and  craves for excess food due to highly illuminated jatharagni by medavrita vata dosha.. Due to above features T2 DM is correlated with Madhumeh6 According to charak samhita madhumeha is considered under astamahagad rogas.Madhumeha being one of the type of vataj prameha is  considered as asadhya roga because of mahatyayikatvat, virudhopakramatvat. As the disease is considered asadhya ,urjaskara chikista is done .
The word diabetes has been derived from two words, diabetes (Greek) which means ‘siphon through’ and mellitus (Latin) which means ‘sweetened with honey’. Type II Diabetes Mellitus is a chronic metabolic disorder characterized by persistent hyperglycemia due to less production of insulin and increased resistance of insulin receptors (due to avaran of insulin receptors by meda dhatu) due to which glucose do not enter the cell effectively and remain in blood in high concentration.  Similarly modern science says that in DM, hyperglycemia occurs by eating too much sugary food, drinking alcohol, not complying with body insulin or exercise. Other risk factors are- Age more than 45 years, Family history of diabetes, Overweight, Smoking or alcohol, High blood cholesterol level, History of high blood pressure, Women with pregnancy related diabetes .

The incidence of diabetes is rising, globally, it is estimated that 366 million people had diabetes in 2011(approximately8.3 percent of the world population, or 3 new cases every 10 sec’s), and this figures expected to reach 522 million by 2030.This global pandemic principally involves type 2 diabetes. The burden of Type 2 Diabetes Mellitus (T2DM) in India is massive, and with 77 million people, the country ranks second for having the highest number of T2DM patients in the world, following China.
In the context of managing Madhumeha, Nygrodadhi Churna and Asandhi Kashaya have been identified as standard drugs. These two drugs were selected from nygrodadhi and asnadhi gana, respectively. Both of these formulations have been extensively researched and established as effective treatments for diabetes in various major articles. These drugs are readily available and cost effective. The novelty of this research lies in exploring the combined action of both Nygrodadhi Churna and Asnadhi kashaya.   
 

 
Close