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CTRI Number  CTRI/2022/08/045050 [Registered on: 30/08/2022] Trial Registered Prospectively
Last Modified On: 29/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Agnikarma and Jalaukavacharana]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Clinical Study to Evaluate The Efficacy of Agnikarma And Jalaukavacharana In Snayugata Vata W.S.R. To Tennis Elbow 
Scientific Title of Study   Comparative Clinical Evaluation of Agnikarma And Jalaukacharana In Snayugata Vata W.S.R. To Tennis Elbow 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devesh Shukla 
Designation  Associate professor 
Affiliation  Gurukul Campus, Haridwar, Uttarakhand Ayurveda University, Dehradun 
Address  OPD No. 7, Shalya Tantra Department, Gurukul Campus, Haridwar, Uttarakhand Ayurveda University, Dehradun

Hardwar
UTTARANCHAL
249404
India 
Phone  7015501865  
Fax    
Email  drdeveshshukla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devesh Shukla 
Designation  Associate professor 
Affiliation  Gurukul Campus, Haridwar, Uttarakhand Ayurveda University, Dehradun 
Address  OPD No. 7, Shalya Tantra Department, Gurukul Campus, Haridwar, Uttarakhand Ayurveda University, Dehradun

Hardwar
UTTARANCHAL
249404
India 
Phone  7015501865  
Fax    
Email  drdeveshshukla@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devesh Shukla 
Designation  Associate professor 
Affiliation  Gurukul Campus, Haridwar, Uttarakhand Ayurveda University, Dehradun 
Address  OPD No. 7, Shalya Tantra Department, Gurukul Campus, Haridwar, Uttarakhand Ayurveda University, Dehradun

Hardwar
UTTARANCHAL
249404
India 
Phone  7015501865  
Fax    
Email  drdeveshshukla@gmail.com  
 
Source of Monetary or Material Support  
OPD NO. 7, Gurukul Campus, Haridwar. Uttrakhand ayurveda University, Dehradun, Uttarakhand, India, 249404 
 
Primary Sponsor  
Name  Gurukul campus Haridwar UAU DEHRADUN 
Address  OPD No. 7, Shalya Tantra Department, Gurukul Campus, Haridwar, Uttarakhand Ayurveda University, Dehradun 
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 Sonia Shekhawat  UAU Gurukul Campus  PG Department of Shalya Tantra, UAU gurukul campus haridwar
Hardwar
UTTARANCHAL 		 7015501865

soniashekhawat079@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Gurukul Campus UAU Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M771||Lateral epicondylitis. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Jalaukacharana (Procedure Reference: Sushruta samhita, sutra sthana, Procedure details: Jalaukacharana is the easiest method of bloodletting. In this procedure, medicinal Leeches are applied to the affected area of patient body. Leech sucks the impure blood and leech saliva have anti-inflammatory, anaesthetics, anticoagulant, vasodilator, antibacterial etc. Total 6 sittings at 7 days interval. Total duration of therapy is 42 days)
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta samhita, chikitsa sthana, chapter 4, Procedure details: Agnikarma is a ayurvedic procedure in which burn/dahana with red hot shalaka due to this immediately pain relief. 3 sittings at 15 days interval. Total duration of therapy is 45 days.)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed patient with tennis elbow.
2.Patients age between 16 to 70 years irrespective of sex, socioeconomic status, religious and occupation. 
 
ExclusionCriteria 
Details  1. Patient associated with Golfer elbow,proximal radio ulnar joint synovitis, olecranon bursitis, previous train, previous surgery, tumor and senile osteoporosis in or around elbow region.
2. Any type of soft tissue injury in or around elbow region. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcomes assessed on basis of 1. subjective parameters like tenderness, swelling, inability to do daily routine activities
2. Objective parameters like pain, wrist extension and palmer flexion by goniometer 		 Both subjective and objective parameters are assessed at 1,7, 14, 21, 35, 42 and 60 dayss 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement will be assessed on the basis of subjective and objective parameters.  60th days 
 
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   N/A 
Date of First Enrollment (India)   01/09/2022 
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="1"
Months="4"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [soniashekhawat079@gmail.com].

  6. For how long will this data be available start date provided 01-09-2022 and end date provided 01-12-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Tennis elbow cause pain, stiffness around elbow region and inability to do daily routine activities because forearm and wrist movements are limited owing to pain. In ayurveda, it is correlated with snayugata vata.
Total 30 patients of tennis elbow will be selected from OPD/IPD of gurukul campus, Haridwar.
15 patients will be treated with agnikarma with 3 sittings at the interval of 10 days.
15 patients will be treated with jalaukavacharana with 5 sittings at 7 days interval.
 
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