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CTRI Number  CTRI/2024/07/069968 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 01/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   udwartana and purification in type 2 diabetes mellitus. 
Scientific Title of Study   A Randomised Comparative Clinical Study To Evaluate the Efficacy of Virechana in Sthula Pramehi (Obese NIDDM) with and without Udwarthana as Purvakarma wsr to assess the Rukshana effect 
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 Suma K J 
Designation  Associate Professor 
Affiliation  G. J. Patel Institute of Ayurvedic Studies and Research 
Address  OPD No 15, Department of Panchakarma, S. G. Patel Ayurveda Hospital and Maternity Home, Anand - 388120
ADIT CAMPUS, BEHIND GIDC, ANAND, Gujarat - 388120
Anand
GUJARAT
388120
India 
Phone  9742786607  
Fax    
Email  sumakumble@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeeta Toshikhane 
Designation  Professor and Head 
Affiliation  Parul Institute of Ayurveda 
Address  Parul Institute of Ayurveda, Parul University, Limda, Waaghodia, Vadodara
Department of PG studies in Panchakarma, Opd no 105, Parul Ayurveda Hospital, Parul University, Limda, Waaghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India 
Phone  9964596479  
Fax    
Email  drsangeetaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suma K J 
Designation  Associate Professor 
Affiliation  G J Patel Institute of Ayurvedic Studies and Research 
Address  G J Patel Institute of Ayurvedic Studies and Research, New Vallabh Vidya Nagar, Anand
Department of PG studies in Panchakarma, Opd No 15, ADIT CAMPUS, BEHIND GIDC, TA/DI-ANAND,Gujarat,388120,India
Anand
GUJARAT
388120
India 
Phone  02692235051  
Fax    
Email  sumakumble@outlook.com  
 
Source of Monetary or Material Support  
G. J. PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH, NEW VALLABH VIDYANAGAR, ANAND - 388120 
 
Primary Sponsor  
Name  Dr Suma KJ 
Address  G J Patel Institute of Ayurvedic Studies and Research, New Vallabh Vidyanagar Anand Gujarat - 388120 
Type of Sponsor  Other [Self ] 
 
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 Suma K J  S G Patel Ayurveda Hospital and Maternity Home  Opd no 15, Dept of Panchakarma
Anand
GUJARAT 		 9742786607

sumakumble@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
G.J. Patel Institute of Ayurvedic Studies And Research,Institutional Ethics Committee  Approved 
Parul Institute of Ayurved, Parul University  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: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sushruta chikitsasthana 11, Procedure details: Snehapana with Priyangwadi Ghrita Sarvang Abhyanga swedan Virechan with Trivruth lehya)
(1) Medicine Name: Priyangwadi ghrita, Reference: Sushruta chikitsasthana 11, Route: Oral, Dosage Form: Ghrita, Dose: 400(ml), Frequency: od, Duration: 4 Days
2Intervention ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: Charaka sutrasthana 5/93, Procedure details: Udwartana will be using Triphala & Kolalullathadi churna, whole body , in opposite direction. followed by virechana.)
(1) Medicine Name: Triphala churna , Reference: Astang Hrudaya Uttartantra 13/14-15, Route: Topical, Dosage Form: Churna/ Powder, Dose: 150(g), Frequency: od, Duration: 7 Days
3Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sushruta chikitsasthana 11, Procedure details: Snehapana with Priyangwadi Ghrita Sarvang Abhyanga swedan Virechan with Trivruth lehya )
(1) Medicine Name: Priyangwadi ghrita, Reference: Sushruta chikitsasthana 11, Route: Oral, Dosage Form: Ghrita, Dose: 400(ml), Frequency: od, Duration: 4 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 New and old cases of Prameha (patients on OHAs also will be taken but not on Insulin)

2 Patients fit for Snehapana

3Patients fit for Virechana karma

4 Patients with Prameha having BMI 25 to 35 kg/m2 (Overweight and Obese)

5 Patients with blood sugar levels FBS more than 126 mg/dl, PPBS more than 180 mg/dl and HbA1c more than 6
 
 
ExclusionCriteria 
Details 
1 Patients with Juvenile Diabetes, IDDM and any other complications or systemic diseases which interfere in the course of treatment.


2 Pregnant woman
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs & symptoms of Diabetes and obesity.

1. FBS
2. PPBS
3. HbA1c
4. BMI
5. Hip waist ratio
6. S. Lipid Profile

 		 day 0,7,14, 90 
 
Secondary Outcome  
Outcome  TimePoints 
FBS, PPBS, HbA1c (Before treatment and after 3 months), Urine sugar
Mutra pareeksha before, after Rukshana and after Virechana (Avila Mutrata – Turbidity) by Spectrophotometer (at Indukaka Ipcowala College of Pharmacy)
Sthoulya – BMI (Measure according to BMI Kg / Height in m2)
Anthropometric measurements – Mid arm circumference, Hip waist ratio
QOL questionnaire (WHO)
 		 2 years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/07/2024 
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="2"
Months="1"
Days="10" 
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  
The burden of Diabetes is high and increasing globally, and in developing economies like India, mainly fueled by the increasing prevalence of Overweight/Obesity and Unhealthy Lifestyles. The estimates in 2019 showed that 77 million individuals had Diabetes in India, which is expected to rise to over 134 million by 2045.
Prameha is a Tri doshaja Vyadhi, mainly with vitiation of Kapha, Meda and Shareera Kleda and Madhumeha (Vataja Prameha) renders the condition more dreadful with association of Vata. Acharyas Charaka and Sushrutha have mentioned Shodhana as the line of treatment for Sthula Pramehi where as Vagbhata has mentioned Vamana and Virechana are the prime treatment in Prameha as it does Kleda shamana. The treatment of Prameha is served by the dual approach of Shodhana and Brimhana in Sthula and Krisha patients respectively.
In this study, Udwarthana has been taken as a Purvakarma before Virechana. According to Acharya Vaghbhata patients who are – Mamsala, Medhura, Bhuri Shleshma, Vishamagni, has to undergo Rukshana as Purvakarma before Snehana. As Prameha is associated with Kapha and Medha dhatu, here also in Sthula Pramehi Udwarthana is selected for Purvakarma in one group.
Group A- receives Udwarthana (Triphala, Kolakulatthadi churna) and Bashpa Sweda as a Purvakarma for 7 days, Shodhananga Snehapana with Priyangwadi Ghrita followed by Virechana.
Group B- (No Udwarthana) receives Deepana Pachana with T. Chitrakadi vati 2bd before food for 3 days (or till nirama lakshanas are seen). Shodhananga Snehapana with Priyangwadi Ghrita till Samyak Snigdha Lakshanas. During Vishrama kala - Sarvanga Abhyanga with Moorchita Tila Taila and Mrudu Bashpasweda will be given for 3days.
 
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