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CTRI Number  CTRI/2023/01/048727 [Registered on: 04/01/2023] Trial Registered Prospectively
Last Modified On: 04/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the Efficacy of Bhudhatrayadi yoga in the management of Madhumeha with special reference to type II Diabetes Mellitus  
Scientific Title of Study   A comparative clinical study to determine the efficacy of Bhudhatrayadi yoga and Metformin in the management of Madhumeha with special reference to type II Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Anjana Mishra 
Designation  Professor and HOD Kayachiktsa Department  
Affiliation  RGGPG Ayurvedic College and Hospital Paprola  
Address  Kayachikitsa Department Room no. 317 RGGPG Ayurvedic College and Hospital VPO Paprola tehsil Baijnath Dist Kangra Himachal Pradesh 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418312324  
Fax    
Email  dranjana269@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anjana Mishra 
Designation  Professor and HOD Kayachiktsa Department  
Affiliation  RGGPG Ayurvedic College and Hospital Paprola  
Address  Kayachikitsa Department Room no. 317 RGGPG Ayurvedic College and Hospital VPO Paprola tehsil Baijnath Dist Kangra Himachal Pradesh 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418312324  
Fax    
Email  dranjana269@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pratibha Thakur  
Designation  PG Scholar 
Affiliation  RGGPG Ayurvedic College and Hospital Paprola  
Address  RGGPG Ayurvedic College and Hospital VPO paprola tehsil Baijnath Dist Kangra Himachal Pradesh 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  8278730646  
Fax    
Email  daisythakur50@gmail.com  
 
Source of Monetary or Material Support  
Charak pharmacy RGGPG Ayurvedic College and hospital paprola H.P. , Baijnath pharmacy, paprola distt kangra H.P. 
 
Primary Sponsor  
Name  Principal  
Address  Rajiv Gandhi government post Graduate Ayurvedic College paprola Himachal Pradesh pin 176115 
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 
Pratibha thakur  Rajiv Gandhi government post graduate Ayurvedic College and hospital   Rajiv Gandhi government post graduate Ayurvedic College and hospital paprola district kangra pin code 176115
Kangra
HIMACHAL PRADESH 		 8278730646

daisythakur50@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee human   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
1Intervention ArmDrugClassical(1) Medicine Name: Bhudhatrayadi yoga, Reference: Yogratanakar uttraradh , prameha chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Tablet Metformin 1gramMedicine Name - Tablet Metformin, Route- Oral , Dosage - 1g , frequency - once a day , duration - 12 weeks
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients willing to participate in the trial .
2. Patients between the age group of 30-65 yrs will be selected for the study.
3. Patients who present with sign and symptoms of Madhumeha as described in classical texts and fulfill the diagnostic criteria .
4. F.B.S. – 150 to 250 mg/dl
P.P.B.S. – 200- 350 mg/dl
HBA1C – > 6.5% to 8 %  
 
ExclusionCriteria 
Details  1.Patients Below the age of 30yrs and above the age of 65yrs.
2.Patients with Type I and Gestational Diabetes .
3.Patients having complications of Diabetes like Nephropathy, Renal Disease , Retinopathy or Cardiac Disease .
Patients suffering from other major illness like C.A. or P.T.B. or any other condition considered to be unfit for enrollment in the trial . 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in following symptoms:
Prabhoot mutrata ------ Polyuria
Pipasa ------ Polydipsia.
Bahu ashee ------ Polyphagia
Alsaya ------ Lethargy.
Kar-pada-daha ------ Burning sensation in hands and feet.
Aavilmutrata ----- Turbidity of urine. 		 Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of Bhudhatrayadi yoga in improving general well being   12 weeks 
 
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 4 
Date of First Enrollment (India)   06/01/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   I would like to publish my trial after completion of the trial as soon as possible.This study is a randomised open clinical trial comparing the safety and efficacy of Bhudhatrayadi yoga and Metformin for 12 weeks in 30 patients with type II Diabetes mellitus .  30 patients will be randomly divided in two groups of 15 patients in each group .  Patients will be selected from IPD/OPD of R.G.G.P.G. Ayurvedic College and Hospital paprola , Himachal Pradesh , India . 
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