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CTRI Number  CTRI/2022/03/041505 [Registered on: 30/03/2022] Trial Registered Prospectively
Last Modified On: 24/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   EFFECT OF TRIPHALA GUGGUL, KARANJADI GHRITA AND GUDUCHI KASHAYAM IN THE MANAGEMENT OF DUSHTA VARNA W.S.R.TO DIABETIC WOUND  
Scientific Title of Study   ClINICAL EVALUATION OF TRIPHALA GUGGUL, KARANJADI GHRITA AND GUDUCHI KASHAYAM IN THE MANAGEMENT OF DUSHTA VARNA W.S.R.TO DIABETIC WOUND  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gitika Chaudhary 
Designation  Post Graduate Scholar  
Affiliation  CHAUDHARY CHARAN SINGH UNIVERSITY  
Address  P.G. Department Of Shalya Tantra, V.Y.D.S. Ayurveda Mahavidyalaya , khurja, bulandshahar

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9855729222  
Fax    
Email  dr.gitikachaudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejaswini J Haryan 
Designation  Assistant Professor DEPARTMENT OF SHALYA TANTRA 
Affiliation  CHAUDHARY CHARAN SINGH UNIVERSITY  
Address  PG Department Of Shalya Tantra, V.Y.D.S. Ayurveda Mahavidyalaya , khurja, bulandshahar

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  8149999455  
Fax    
Email  drtejaswiniharyan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gitika Chaudhary 
Designation  Post Graduate Scholar 
Affiliation  CHAUDHARY CHARAN SINGH UNIVERSITY  
Address  PG Department Of Shalya Tantra, V.Y.D.S. Ayurveda Mahavidyalaya, khurja, bulandshahar

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9855729222  
Fax    
Email  dr.gitikachaudhary@gmail.com  
 
Source of Monetary or Material Support  
PG Department Of Shalya Tantra, V.Y.D.S. Ayurveda Mahavidyalaya ,khurja, bulandshahar 
 
Primary Sponsor  
Name  PG Department Of Shalya Tantra VYDS Ayurveda Mahavidyalaya 
Address  PG Department Of Shalya Tantra, V.Y.D.S. Ayurveda Mahavidyalaya ,khurja, bulandshahar 
Type of Sponsor  Private 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 Gitika Chaudhary  PLRD HOSPITAL  PG Department Of Shalya Tantra, V.Y.D.S. Ayurveda Mahavidyalaya , Khurja
Bulandshahar
UTTAR PRADESH 		 9855729222

dr.gitikachaudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vaidya Yugya Dutt Sharma Ayurved Mahavidyalaya Ethical Committee , Khurja  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-prakShAlana-karma, प्रक्षालन-कर्म (Procedure Reference: Ayurved literature , Procedure details: 1.For 10 days Prakshalan with Guduchi kashay twice a day will be done with Dressing of Karanjadi ghrita and triphala guggul 500mg Bd orally. 2.For Next 10 days Prakshalan with Guduchi kashay once a day will be done with Dressing of Karanjadi ghrita and triphala guggul 500mg Bd orally. 3.For Next 10 days Prakshalan with Guduchi kashay once on alternate day will be done with Dressing of Karanjadi ghrita and triphala guggul 500mg Bd orally.)
(1) Medicine Name: Guduchi kashay, Reference: Ayurved literature , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: bd, Duration: 4 Weeks
(2) Medicine Name: Karanjadi ghrita, Reference: Ayurved literature , Route: Topical, Dosage Form: Ghrita, Dose: 150(ml), Frequency: bd, Duration: 4 Weeks
(3) Medicine Name: Triphala guggul, Reference: Ayurved literature , Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 4 Weeks
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with clinical features of Dushta varna(diabetic wound DMT2)  
 
ExclusionCriteria 
Details  1.Patients DMT1
2. Patients with gangrene, HIV, Hbsag, VDRL, HCV.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wound will heal
Assessment Criteria: -
A)The patients were assessed on the basic of subjective and

objective parameter before and after treatment.
1. If there is 100% improvement, it will be considered as complete

healing.

The results will be categorised were as below:

1. Marked Healing- 75% improvement

2. Moderate Healing-50 to 75 % improvement
3. Mild Healing 25 to 50 % improvement

4. Satisfactory Healing-25% improvement
 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Wound will not detoriate with no complications   1week 
 
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 2 
Date of First Enrollment (India)   04/04/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Trial will be conducted with aim to evaluate effect of triphala guggul, karanjadi ghrita and guduchi kashaym in management of dusht varna with special reference to diabetic wound of patients. 
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