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CTRI Number  CTRI/2025/03/081971 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluate The Effecacy Of Madhumehari Churna And Diet Modification On Blood Sugar Level In Pre-Diabetes Patients 
Scientific Title of Study   A Randomized Controlled Trial To Evaluate The Effecacy Of Madhumehari Churna And Diet Modification On Serum Blood Glucose Level In Pre-Diabetes Patients 
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 Yogesh Kumar Khatarker 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda Jaipur 
Address  Room No. 201 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9713413506  
Fax    
Email  dryogesh10684@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Kumar 
Designation  Associate Professor  
Affiliation  National Institute Of Ayurveda Jaipur 
Address  Room No. 204 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9555554077  
Fax    
Email  drravikumar786@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Kumar 
Designation  Associate Professor  
Affiliation  National Institute Of Ayurveda Jaipur 
Address  Room No. 204 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur


RAJASTHAN
302002
India 
Phone  9555554077  
Fax    
Email  drravikumar786@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 
 
Primary Sponsor  
Name  National Institute Of Ayurveda Jaipur 
Address  National Institute Of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 
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 Yogesh Kumar Khatarker  National Institutute of Ayurveda   Jorawar Singh Gate Amber Road Jaipur
Jaipur
RAJASTHAN 		 9713413506

dryogesh10684@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Madhumehari Churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information:
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Grains Yava Godhuma Rice Pulses Chanaka Toor Dal Mudga Vegetables Methi Patola Karella Fruits Jambu Talaphala Amalaki Emblica Dadima Seeds Methi Kamala Utpala , Apathya:Nil
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between the age group of 18-60 year of either sex.
Fasting blood glucose level within range 110-125 mg/dl.
HbA1c level within range 5.7-6.4%
 
 
ExclusionCriteria 
Details  Those already diagnosed with diabetes.
Subjects with serious medical, surgical or oncological conditions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in blood glucose level  15 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in HbA1c level, Lipid profile & BMI  0 & 12 weeks 
 
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   Phase 2 
Date of First Enrollment (India)   10/04/2025 
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="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  

NEED OF STUDY:

According to the International Diabetes Federation, Pre-diabetes has a prevalence of 16.8% worldwide. In India, its prevalence is 10.3% [4]. Since Pre-diabetes is a condition with a very significant prevalence, and if left unaddressed, can lead to serious conditions like Diabetes Mellitus, Cardiovascular diseases and Stroke, use of Madhumehari Churna or diet modifications for limiting this condition in the pre-pathogenesis stage can be a very beneficial treatment regimen.

            Non-communicable diseases pose a great threat to Global Health in the present era, and Pre-diabetes is a precursor to various such non-communicable diseases. Elevated glucose level is an important metabolic risk factor for non-communicable diseases and unhealthy dietary habits is also an important modifiable risk factor in the development of non-communicable diseases. This study addresses elevated glucose level through the use of Madhumehari Churna and unhealthy dietary habits through diet modification.

Moreover, limiting any disease in its pre-pathogenesis stage is an important type of primary prevention, a very effective level of prevention in disease epidemiology. There have been some researches done on effect of Madhumehari Churna in Diabetes but we do not find researches done on its effectiveness in Pre-diabetes condition. Hence, this study can be helpful in finding a way to limit pre-diabetes so that it doesn’t progress into even serious conditions.

AIM:

To assess and compare the efficacy of Madhumehari Churna and Diet Modification in Pre-diabetic patients.

OBJECTIVES:

Primary Objective: To compare the efficacy of Madhumehari Churna and Diet Modification in Pre-Diabetic Patients in reducing fasting blood glucose level.

Secondary Objective:

  1. To assess the impact of both interventions on HbA1c level, Lipid Profile and BMI.
  2. To prepare a diet module for prediabetic persons.

RESEARCH QUESTION:

Does Madhumehari Churna demonstrate any effect in management of Pre-diabetic patients compared to Diet Modification?

 

HYPOTHESIS:

Null Hypothesis [Ho]: There is no difference in the efficacy of Madhumehari Churna compared to Diet Modification on serum blood glucose level in Pre-diabetic patients.


 
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