| 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 |
|
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Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - will be displayed with study
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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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.
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