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CTRI Number  CTRI/2025/02/080421 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Managment of Madhumeha (Diabetes type 2) through Kutjadi Kashaya. 
Scientific Title of Study
Modification(s)  
THE EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA WSR TO TYPE 2 DIABETES MELLITUS  
Trial Acronym  THE EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA WSR TO TYPE 2 DIABETES MELLITUS  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Prajapati 
Designation  MD Scholar 
Affiliation  Govt. Ayurveda College and Hospital, Nipaniya Rewa 
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa M.P Rewa MADHYA PRADESH 486001 India

Rewa
MADHYA PRADESH
486001
India 
Phone  7470729626  
Fax    
Email  drdeepakkumarprajapati1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravanjan Acharya 
Designation  professor and HOD 
Affiliation  Govt. Ayurveda College and Hospital, Nipaniya Rewa  
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa M.P Rewa MADHYA PRADESH 486001 India

Rewa
MADHYA PRADESH
486001
India 
Phone  9827459956  
Fax    
Email  dr.pravanjan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SN Tiwari 
Designation  Associate Professor 
Affiliation  Govt. Ayurveda College and Hospital, Nipaniya Rewa  
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa M.P Rewa MADHYA PRADESH 486001 India

Rewa
MADHYA PRADESH
486001
India 
Phone  7581808285  
Fax    
Email  drsntiwari9@gmail.com  
 
Source of Monetary or Material Support  
Govt Ayurveda College and Hospital Nipaniya Rewa 
 
Primary Sponsor  
Name  Govt Ayurveda College and Hospital Nipaniya Rewa 
Address  Dept. of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa 
Type of Sponsor  Government 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 deepak prajapati  Govt.Ayurveda College Nipaniya Rewa m.p  Dept.of Samhita Siddhant Govt.ayurveda college nipaniya rewa m.p Rewa MADHYA PRADESH 486001 India
Rewa
MADHYA PRADESH 
7470729626

drdeepakkumarprajapati1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kutajadi Kashaya, Reference: su.chi 11/8, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NIL
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients fulfilling the Diagnostic criteria with classical symptoms of Madhumeha
Patients of both sexes in the age group of 30-65 years.
Patients who are willing to give written consent for participation in this study.
 
 
ExclusionCriteria 
Details  Patients with juvenile diabetes.
Patients having IDDM and receiving insulin (type 1).
Excessive blood glucose (FBS) greater than 375 mg/dl and (PPBS) greater than 500 mg/dl.
HbA1c greater than 9.0 percent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters like 1. Prabhuta mutrata,Avila mutrata,Kshuadhikya,Pipasa adhikya,Nidradhikya, Baddhata   0 to 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of trial drugs in improving
the signs, symptoms as per assessment criteria 
after 21 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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/ Phase 4 
Date of First Enrollment (India)   25/04/2025 
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="2"
Months="0"
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  
 

TITLE :

EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA W.S.R. TO TYPE 2 DIABETES MELLITUS.

AIM :

To assess the effect of Sushrutokta Kutajadi Kashaya in Madhumeha w.s.r. to Type 2 Diabetes Mellitus.

OBJECTIVE :

 To describe the probable mode of action of Kutajadi Kashaya in treatment of Madhumeha.

 To assess the efficacy of Sushrutokta Kutajadi Kashaya in improvement of clinical manifestations of Madhumeha.

           

INTRODUCTION:

Diabetes Mellitus type 2 in ayurveda correlate with madhumeha under the heading of prameha described in bruhatrayee and laghutrayee, mostly observed in age group 30 to 50 years of age . Amongst the many dreadful conditions arising because of modern,day living, Diabetes Mellitus  is a giant disease considered as one of the archenemies of the humankind caused by improper diet and lifestyle.

It is often referred to as a silent killer. Diabetes and its complications pose a major threat to public health resources throughout the world. Looking at its gravity, the World Health Organization WHO has taken up a close vigilance and survey about this problem the world over. The WHO  statement on primary health care program states that there is a collective failure to deliver in line with these values which is painful and deserves our greatest attention. Also there is an inability of health services to deliver the level of national coverage that meets the stated demand and changing needs.

This scientific holistic work inspired from Ayurveda with a special focus on diet and lifestyle can seriously contribute into the DM management and primary health care program. Taking these facts into consideration, the present study was  undertaken to evaluate the effect of Ayurvedic diet and lifestyle  with Kutajadi Kwatha in Madhumeha .

NEED OF RESEARCH:

The prevalence of diabetes in India has risen from 7.1% in 2009 to 8.9% in 2019, 25.2 million adults are estimated to have diabetes, which is estimated to increase to 35.7 million in the year 2045.

India ranks second after China in the global diabetes epidemic with 77 million people with diabetes. Of these, 12.1 million are aged >65 years, which is estimated to increase to 27.5 million in the year 2045. It is also estimated that nearly 57% of adults with diabetes are undiagnosed in India, which is approximately 43.9 million.

Thus, measures of controlling and prevention of diabetes need to be done so as to manage and prevent the disease accordingly.

STUDY DESIGN:

·       Study type : Interventional

·       Purpose : Treatment

·       Maskingn : Open labelled clinical trial

·       Direction : Prospective

·       End Point : Efficacy

·       No. of group : single group

  • Sample size  50 patients.

TREATMENT REGIMEN:

  • Drug  Kutajadi Kashaya
  • Form  Kashaya
  • Duration  30 days
  • Follow Up  06 months.
  • Dose 30 ml twice a day before meal.
  • Anupana  lukewarm water koshna jala
  • DRUG - Kutajadi Kashaya  Su.Chi.11/8

    CONTENT:

    1.     Kutaja

    2.     Kapittha

    3.     Rohitaka

    4.     Bibhitaka

    5.     Saptaparna

  • PROBABLE MODE OF ACTION: 

     All pramehas are tridoshaja while kutajadi kashaya is tridosha shamaka. kutajadi 

    kashaya having tikta kashaya rasa, ushna virya anti hypoglycaemic property. 

     kutajadi kashaya is tikta kasaya rasa pradhana having katu vipaka and ushna virya 

    with laghu,ruksha guna predominance. 

     Practically most of patients.with madhumeha having history of consumption of 

    viruddha ahara and unhealthy life style as described in ayurveda leads to excessive 

    vitiation of kapha, pitta, meda, mamsa dhatu is responsible for madhumeha.

     So considering the kapha,mamsa,meda predominance in madhumeha tikta kasaya

    rasa and katu vipak,ushna virya of kutjadi kashaya will be best kapha,mamsa,meda

    shamaka. 

     Laghu ruksha guna and tikta kashaya rasa of kutajadi Kashaya with its deepana

    pachana karma helps improve metabolism by the properties of amapachana 

     Ushna virya of kutajadi kashaya acts as vata shamaka, stroto shodhaka and kledaka

    shoshaka, eliminates morbid doshas accumulated in the body 

    RESEARCH QUESTION: 

     Is Kutajadi Kashaya effective in relieving the symptoms of Madhumeha when taken 

    for 30 days ? 

    HYPOTHESIS: 

     NULL HYPOTHESIS: 

     H0  Kutajadi Kashaya is not effective in relieving the symptoms of Madhumeha. 

     ALTERNATE HYPOTHESIS: 

     H1  Kutajadi Kashaya is effective in relieving the symptoms of Madhumeha



 
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