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CTRI Number  CTRI/2020/12/029607 [Registered on: 07/12/2020] Trial Registered Prospectively
Last Modified On: 04/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   use of Durvadi Taila and Panchvalkal Ointment in Post Operative Wound Healing 
Scientific Title of Study   A Comparative Study Of Durvadi Taila and Panchvalkal Ointment in Post Operative Wound Healing 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DIKSHA TRIVEDI  
Designation  MS Scholar, department of shalya Tantra 
Affiliation  university college of ayurveda 
Address  room no 7, PG department of Shalya Tantra, university college of ayurveda, Dr. sarvepalli RadhaKrishnan rajasthan ayurved university jodhpur, rajasthan -342037
room no 7, PG department of Shalya Tantra, university college of ayurveda, Dr. sarvepalli RadhaKrishnan rajasthan ayurved university jodhpur, rajasthan -342037
Jodhpur
RAJASTHAN
342037
India 
Phone  9461846271  
Fax    
Email  nprshrimali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh kumar Gupta 
Designation  Associate professor and HOD, PG department of shalya tantra  
Affiliation  university college of ayurveda 
Address  room no 7, PG department of Shalya Tantra, university college of ayurveda, Dr. sarvepalli RadhaKrishnan rajasthan ayurved university jodhpur, rajasthan -342037
room no 7, PG department of Shalya Tantra, university college of ayurveda, Dr. sarvepalli RadhaKrishnan rajasthan ayurved university jodhpur, rajasthan -342037
Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  DIKSHA TRIVEDI 
Designation  MS scholar,PG department of shalya tantra 
Affiliation  university college of ayurveda 
Address  room no 7, PG department of Shalya Tantra, university college of ayurveda, Dr. sarvepalli RadhaKrishnan rajasthan ayurved university jodhpur, rajasthan -342037
room no 7, PG department of Shalya Tantra, university college of ayurveda, Dr. sarvepalli RadhaKrishnan rajasthan ayurved university jodhpur, rajasthan -342037
Jodhpur
RAJASTHAN
342037
India 
Phone  9461846271  
Fax    
Email  nprshrimali@gmail.com  
 
Source of Monetary or Material Support  
dr. sarvepalli radha krishnan rajasthan ayurved university, karwar, jodhpur,342037 
 
Primary Sponsor  
Name  dr sarvepalli radha krishnan rajasthan ayurved university 
Address  dr. sarvepalli radha krishnan rajasthan ayurved university, nagaur road, karwar, jodhpur,342037 
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 DIKSHA TRIVEDI  dr. sarvepalli radha krishnan rajasthan ayurved university,jodhpur  opd-7, opd and ipd of shalya tantra department, university college of ayurveda, DSRRAU, nagaur road, karwar,jodhpur-342037
Jodhpur
RAJASTHAN 		 9461846271

nprshrimali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, DSRRAU,jodhpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DURVADI TAILA   local application for 30 days  
Comparator Agent  Nil  Nil 
Intervention  PANCHVALKAL OINTMENT   local application for 30 days  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  •Patient willing to sign the consent form.

•Patient not taking any other medicine.
•Patient with classical symptoms of wound healing.
•Patient is fit for the procedure.
•Tidy wounds
•Those wound in which healing with primary intention.
 
 
ExclusionCriteria 
Details  •Patient with Leprosy, Tuberculosis, and Paralysis.
•Patient with uncontrolled Hypertension/ Cardiac problem/ Diabetes Mellitus and any systematic disorder.
•Open wound at or proximity of the lesion infected lesion
•Specific as well as non- specific infections.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
improvement in subjective and objective parameters.  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in subjective and objective parameters  after 30 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   15/12/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   this trail will be conducted to evaluate the efficacy of durvadi taila and panchvalkal ointment in the management of post operative wound healing. in group-1 local application of durvadi taila will be done for 1 month. in another group local application of panchvalkal ointment for 30 days will be done.   
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