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CTRI Number  CTRI/2024/11/076799 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 01/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   STUDY ON SAFETY AND EFFICACY OF NEW AGNIKARMA DEVICE AND OLD AGNIKARMA METHOD IN REDUCING PAIN OVER ELBOW JOINT  
Scientific Title of Study   Safety and efficacy of a novel Agnikarma device and conventional Agnikarma method in the management of Tennis elbow pain - A pilot study. 
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 Sheela Karalam B 
Designation  Physician  
Affiliation  Vaidyaratnam Ayurveda Research Institute  
Address  R and D Department Room No 3 Vaidyaratnam Ayurveda Research Institute

Thrissur
KERALA
680306
India 
Phone  9446533770  
Fax    
Email  sheelakaralam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lekshmipriya 
Designation  Physician  
Affiliation  Vaidyaratnam Ayurveda Foundation Hospital 
Address  Shalyatantra Speciality Clinic Room No 7 Vaidyaratnam Ayurveda Foundation Hospital

Thrissur
KERALA
680306
India 
Phone  8921432417  
Fax    
Email  lekshmipriya071@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dileep K S 
Designation  Physician  
Affiliation  Vaidyaratnam Ayurveda Hospital 
Address  Speciality Clinical Department Room No 2 Vaidyaratnam Ayurveda Foundation Hosptal

Thrissur
KERALA
680306
India 
Phone  09961045901  
Fax    
Email  dileepkshankar@gmail.com  
 
Source of Monetary or Material Support  
Vaidyaratnam Ayurveda Foundation Hospital Ollur, Thaikkattussery , Thrissur - 680306, Kerala, India 
 
Primary Sponsor  
Name  Dr Sheela Karalam B 
Address  Vaidyaratna Ayurveda Research Institute Ollur, Thaikkattussery, Thrissur - 680306, Kerala, India 
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 
DrLekshmipriya  vaidyaratnam ayurveda foundation hospital  room no . 10 dept. of shalya thantra vaidyaratnam ayurveda foundation hospital thaikkattusseri ollur thrissur
Alappuzha
KERALA 
8921432417

lekshmipriya071@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH  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-agnikarma, अग्निकर्म (Procedure Reference: su.sa - su 12 th chapter , Procedure details: Agnikarma is performed with the help of probe of Agnikarma device ( Temperature is set at 300 to 3500C in the device ) in Bindhu (dot) pattern. Heat is applied to 10 to 15 points, according to tender sites involved. Immediately fresh ghrithakumari gel is applied over the burnt spots. )
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: su . sa su - 12 th chapter, Procedure details: Agnikarma is performed with the help of red hot panchaloha shalaka in Bindhu (dot) pattern. Heat is applied to 10 to 15 points, according to tender sites involved. Immediately fresh ghrithakumari gel is applied over the burnt spots. )
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Subjects satisfying diagnostic criteria of tennis elbow, i.e. pain and tendernes on the lateral epicondyle of humerus bone and a positive response to Cozen’s test.
•Age group – 25 to 60 years, irrespective of gender.
•Subjects ready to give written informed consent and willing to comply the study protocol

 
 
ExclusionCriteria 
Details  1.Subjects with uncontrolled Diabetes mellitus.
2.Subjects with the history of Malignant tumors, senile osteoporosis in and around the elbow region, compound fracture/ pathological fracture, non-united fracture of lateral epicondyle.
3.Subjects suffering from infectious diseases like HIV or Hepatitis B.
4.Subjects on any Analgesics or NASIDS or corticosteroids.
5.Pregnant or lactating females.
6.Presence of any severe medical or psychological condition or chronic condition/ inflammation/ infection
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale
Tenderness over lateral epicondyle

response to cozens test  
( o th day – before and after procedure , 7 th day 
 
Secondary Outcome  
Outcome  TimePoints 
post operative assessment - burn, allergic reactions, surgical site infections , other adverse events   after procedure and 7 th day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   18/11/2024 
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="0"
Months="0"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Tennis elbow or lateral epicondylitis is a common condition of young and middle aged people, where the patient complains of pain in the elbow particularly in certain movements like pouring the tea, turning of stiff door handle, lifting the mug etc. Due to unaccustomed use there will be damage to the common extensor origin which is attached to the lateral epicondyle. Damage is followed by subsequent adhesions with untorn fibers and joint capsule. It is clinically diagnosed by sensation of pain and tenderness at the lateral epicondyle of humerus, which aggravates during the resisted dorsiflexion of the wrist and fingers.  Tennis elbow may be correlated with the condition of Snayugata vata, described in Ayurveda. Ayurveda has advocated various treatment modalities such as Snehana, Upanaha, Agnikarma and Bandhana for snayugatavata. Among these Agnikarma seems to be more effective in providing instant symptomatic relief. Agnikarma is a therapeutic heat burn therapy performed with the help of hot Shalaka (Probe) and it is an effective procedure for management of pain in Ayurveda. This  pilot trial aims to evaluate the comparative safety and efficacy of a Novel Agnikarma device and conventional agnikarma method in reducing pain of Tennis elbow.  20 subjects satisfying the inclusion criteria will be screened and selected for the study.  The criteria of assessment is pain, tenderness,  response to Cozen’s test  and post operative assessment – Burn, Allergic reactions, surgical site infections, other adverse events. The subjects will be  assessed before treatment, immediately after treatment  and on 7th day of treatment using required assessment scales

 
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