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CTRI Number  CTRI/2024/05/066990 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic trail for treatment of Diabetes mellitus. 
Scientific Title of Study   A comparative randomized clinical study to evaluate the efficacy of Nitya Virechana with Trivrita kwatha and Aaragvadha Kwatha in the management of Madhumeha (Diabetes mellitus II) 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Kumar Majhi 
Designation  PG Scholar 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan, Kheradabar, Najafgarh, New delhi 
Address  Room number-123 Departnment of Panchakarma Chaudhary Brahm Prakash Ayurved Charak Sansthan,Kheradabar, Najafgarh, New delhi

South West
DELHI
110073
India 
Phone  9556215860  
Fax    
Email  rakeshmahji999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Kumar Katara 
Designation  Assistant Professor 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room no-144,PG Department of Panchkarma, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Delhi

South West
DELHI
110073
India 
Phone  9910430500  
Fax    
Email  pankaj_katara@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Kumar Katara 
Designation  Assistant Professor 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room no-144,PG Department of Panchkarma, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Delhi

South West
DELHI
110073
India 
Phone  9910430500  
Fax    
Email  pankaj_katara@yahoo.co.in  
 
Source of Monetary or Material Support  
Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New delhi,India, 110073 
 
Primary Sponsor  
Name  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Khera Dabar, Najafgarh,New Delhi-110073 
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 Rakesh Kumar Majhi  Ch.Brahm Prakesh Ayurved Charak Sansthan,department of panchaakarma  Room no- 123,PG Department panchakarma,Ch.Brahm Prakesh Ayurved Charak Sansthan,Kherada Dabar,Najafgarh, New Delhi,110073
South West
DELHI 		 9556215860

rakeshmahji999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee-Ch.Brahm Prakesh Ayurved Charak Sansthan  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 ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Chakradutta prameha rogaadhikar chapter -9, Procedure details: Virechan with 60ml araghavadha kwath for 21 days)
(1) Medicine Name: Argavadha kwatha, Reference: Chakradutta prameha rogaadhikar chapter -9, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 60(ml), Frequency: od, Duration: 21 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म Pradhan Karma(Procedure Reference: Charaka Chikisthasthan 6, Procedure details: Nitya Virechana for 21day )
(1) Medicine Name: Trivrita Kwatha, Reference: Charaka Kalpasthan 6, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 60(ml), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  32.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Newly diagnosed patients of Diabetes mellitus type-2
2.Patient fit for virechan
3.Patient who is taking or not taking medicines.
4.Patient whose blood sugar level comes in range as follows- FBS - 120-180mg/dl, PPBS- 150-250mg/dl 
 
ExclusionCriteria 
Details  1.Insulin dependent diabetes mellitus or those who are under insulin therapy.


2.Patients with chronic diabetic complications like nephropathy, neuropathy and retinopathy.


3.Patients with severe systemic diseases like HIV, Cancer, Hepatitis etc.


4.Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Nitya Virechana Karma with Trivrita Kwatha may show better results on maintaining the blood glucose level in comparison to Nitya Virechana with Aragvadha Kwatha.  0,1,14,21,42th day 
 
Secondary Outcome  
Outcome  TimePoints 
Nitya Virechana Karma with Trivrita Kwatha may show better results on maintaining the blood glucose level in comparison to Nitya Virechana with Aragvadha Kwatha  21 day 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 
Date of First Enrollment (India)   20/05/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The study is comparative randomized clinical study to evaluate the efficacy of Nitya Virechana with Aaragvadha Kwatha and Trivrita Kwatha in management of Madhumeha (Diabetes mellitus â…¡). In one group Trivrita kwatha 60ml will be given daily for 21 day and follow up done on 42th day. In another group Aaragavadha kwatha 60ml will be given daily for 21 day and again follw up done on 42th day. The trial will be conducted in Ch. brahm prakash ayurved charak sansthan with outcome ; nitya virecahana with Trivrita kwatha may show better efficacy than nitya virechana with Aaragvadha in the management of madhumeha in improving FBS and PPBS value and other associated symptoms. 
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