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CTRI Number  CTRI/2024/05/067403 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing wet cupping against Agnikarma using Panchaloha salaka in the management of Tennis Elbow to know which is better.  
Scientific Title of Study   Randomized comparative clinical trial to evaluate the effectiveness of wet cupping against Agnikarma using Panchaloha salaka in the management of Tennis elbow 
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. SINI GEORGE 
Designation  PG SCHOLAR 
Affiliation  VPSV Ayurveda College Kottakkal 
Address  Department of Shalyathantra, VPSV Ayurveda College Kottakkal, Edarikkode p o, Malappuram Kerala.

Malappuram
KERALA
676501
India 
Phone  9400353171  
Fax    
Email  sinisijo100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. REJANI H 
Designation  Professor and HOD 
Affiliation  VPSV AYURVEDA COLLEGE KOTTAKKAL 
Address  Department of Shalyathantra, VPSV Ayurveda College Kottakkal, Edarikkode p o, Malappuram Kerala.

Malappuram
KERALA
676501
India 
Phone  9447270227  
Fax    
Email  drrejaniharidas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. REJANI H 
Designation  Professor and HOD 
Affiliation  VPSV AYURVEDA COLLEGE KOTTAKKAL 
Address  Department of Shalyathantra, VPSV Ayurveda College Kottakkal, Edarikkode p o, Malappuram Kerala.

Malappuram
KERALA
676501
India 
Phone  9447270227  
Fax    
Email  drrejaniharidas@gmail.com  
 
Source of Monetary or Material Support  
VPSV Ayurveda College Kottakkal. Malappuram dist. Kerala. India. 
 
Primary Sponsor  
Name  VPSV Ayurveda College Kottakkal 
Address  Department of Shalyathantra, VPSV Ayurveda College Kottakkal,Edarikkode p o, Malappuram Kerala. India. 
Type of Sponsor  Other [Aided 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 SINI GEORGE  VPSV AYURVEDA COLLEGE KOTTAKKAL  OPD of Department of Shalyathantra,Room number A101, VPSV Ayurveda College Kottakkal, Edarikkode P O. Malappuram, Kerala, India ,676501
Malappuram
KERALA 		 09400353171

sinisijo100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe VAIDYARATNAM P.S.VARIER AYURVEDA COLILEGE Kottakkal, Edarikode 676 501 V  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: VRANASOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma अिfकम (Procedure Reference: Susrutha samhitha, Procedure details: Pradhāna karma The patient will be blind folded and seated on a chair with 90 o abducted shoulder. The elbow will be bent to 90˚. Agnikarma will be done over the tender point within 2.5 cm radius on lateral epicondyle with heated Pańcalōha śalāka in 3 bindhu pramana in one tender point. Paścātkarma A mixture of equal quantity of Madhu and Ghrita will be applied immediately after agnikarma. )
2Intervention ArmProcedure-SrRu~ggAvacaraNam nृंगावचरणम using Hijama cup (Procedure Reference: previous case report, Procedure details: Pradhāna karma Hijama cup number 6 will be kept on lateral epicondyle and extensor origin. suction will be given for 10 minutes initially. The cups will be removed, and 2 pricks will be given with 18- gauge needle on the site where the cups were initially placed. suction will be given for 10 minutes. Paścātkarma The suction will be removed, and the site will be cleaned with Povidone iodine solution and bandaged. Vitals will be monitored. )
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Participants diagnosed with Tennis Elbow
•Participants with informed consent.

 
 
ExclusionCriteria 
Details  Participants in whom rakthamokshana and Agnikarma are contraindicated.
Participants with fractures of affected limb.
Known case of bleeding disorders like HIV, Hepatitis B. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cozen’s test using numerical rating scale.
Mill’s manoeuvre using numerical rating scale.
Tenderness on lateral epicondyle
Active flexion and extension of wrist using goniometer.

 		 0th,1st,8th and 24th days.

 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing prakriti of the participants having Tennis elbow.  At base line 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/06/2024 
Date of Study Completion (India) 03/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

A Randomized comparative clinical trial is planned to evaluate the effectiveness of wet cupping against Agnikarma using PaÅ„calōha Å›alāka in the management of Tennis elbow. Tennis elbow or lateral epicondylitis is a type of repetitive strain injury due to over exertion of common extensor tendon, its micro trauma or its failed healing. An injury due to repetitive micro traumas to tendon is the main cause for tennis elbow and it is considered as Vrana. Agnikarma and Raktamōká¹£ana are proved to have effect in Tennis elbow. This trial is planned to find out a treatment procedure      which will be more effective and patient friendly for the management of Tennis elbow.Raktamōká¹£ana with hijama cup which is a modified ṡṛiá¹…ga procedure is found to have less tissue damage and less pain during procedure. It is also patient friendly and increases blood flow to the area which helps in better healing of tendon. Assessment will be done before and after treatments using required assessment tools like pain assessment using VAS scale, Cozen’s test using numerical rating scale, Mill’s manoeuvre using numerical rating scale and Tenderness on lateral epicondyle.



 

 
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