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CTRI Number  CTRI/2026/01/100824 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of pain in elbow joint through heat therapy. 
Scientific Title of Study   AN OPEN LABELLED RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF VIDDHA AGNIKARMA IN THE MANAGEMENT OF SNAYUGATHA VATA VIS-À-VIS 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 Aiyanna P P 
Designation  Associate professor 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Room no.10 Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical college and Hospital, #41/E, Lalithadripura road, Mysuru-570028

Mysore
KARNATAKA
570028
India 
Phone  9738460501  
Fax  08212548360  
Email  draiyanna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aiyanna P P 
Designation  associate professor 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Room no.10 Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical college and Hospital, #41/E, Lalithadripura road, Mysuru-570028

Mysore
KARNATAKA
570028
India 
Phone  9738460501  
Fax  08212548360  
Email  draiyanna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aiyanna P P 
Designation  associate professor 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Room no.10 Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical college and Hospital, #41/E, Lalithadripura road, Mysuru-570028

Mysore
KARNATAKA
570028
India 
Phone  9738460501  
Fax  08212548360  
Email  draiyanna@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital, Lalithadripura road, Mysuru, Karnataka, India, 570028 
 
Primary Sponsor  
Name  JSS MAHAVIDYAPEETHA MYSURU 
Address  Dr Shivarathri Rajendra circle, Agrahara, Fort Mohalla, Mysuru, Karnataka 570004 
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 Aiyanna P P  JSS Ayurveda Medical College and Hospital  Department of Shalya Tantra, OPD No.10, JSS Ayurveda Medical College and Hospital, Lalithadripura Road, Mysuru, 570028
Mysore
KARNATAKA 
9738460501

draiyanna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M659||Synovitis and tenosynovitis, unspecified. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susruta Samitha, Sutra sthana, 12th Chapter, Procedure details: The sterile acupuncture needles will be pricked at the depth of 5mm-10mm at previously marked tender points. Electrode will be placed below the subject. The active electrode will be gently touched to needles. Total 3 rounds of Agnikarma will be done with in 5 to 10 seconds gap. After that the needles are removed. )
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susruta samhita, Sutra sthana, 12th chapter, Procedure details: The Panchaloha Shalaka will be heated to red hot. Bindu Roopi Agnikarma was done over the marked sites. The sites were observed for Samyak Dagdha Lakshana. )
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects with Pratyatma Lakshanas of like Ruk (pain),Stambha (stiffness)) and ascertained by Mill’s Test and cozens test. Age group- 30 to 60 years irrespective of gender. Controlled diabetes mellitus and Hypertension.

 
 
ExclusionCriteria 
Details  Elbow fracture, Rheumatoid arthritis. Pregnancy and Lactation. Patients with systemic diseases like Uncontrolled diabetes mellitus, septic bursitis.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Pain  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Maintaining the result of primary outcome  15th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   17/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Introduction:
Acharya Sushrutha   has   explained the importance of Agnikarma in cases of highly painful conditions precipitated by Vata affecting  Sira, Snayu, Sandhi and Asthi . Pain in the lateral aspect of the elbow is commonly known as Tennis elbow or Lateral epicondylitis. It is estimated to affect 1–3% of the adult population each year and is more common in the dominant arm. Although it can occur as an acute injury (trauma to the lateral elbow), it’s also seen in labourers who utilise heavy tools or engage in repetitive gripping or lifting task, who carryout repetitive, one sided movements in their jobs like electricians, carpenters, needle work, knitting, gardening.
Tennis elbow is difficult to cure with conventional medicines  and  we can consider  the role of Agnikarma in reducing the pain of tennis elbow. On the basis of signs and symptoms, tennis elbow can be correlated with Snayugata Vata described in Ayurveda Samhitha.  
Snayugata Vata is developed when the vata dosha aggravates due to atichesta, ativyayam, etc and gets localized in snayu of kurpara sandhi
The vayu responsible for this function is, vyanavayu.  Ultimately unable to carry out the function of kurpara sandhi (elbow joint) and hasta pradesha (forearm) smoothly. The features such as pain, stiffness and restricted movements develop  in this region  These symptoms may also develop due to kaphavritta vyana vayu. Hence, it is also considered an important causative factor for manifestation of Snayugatha Vata. The disease which are situated over Twak, Mamsa, Snayu, Asthi are treated with Agnikarma using different Dahanopakaranas. Acharya Chakradattahas added Suchi also one among the Dahanopakaranas. Bindu  Roopi  Agnikarma with Panchaloha Shalaka is being extensively done and it has proved its efficacy.
   But as it involves burning of the skin & superficial tissues there may be discomfort to the   patient and also skin scarring. The uniformity of heat is not maintained throughout the procedure. Viddha Agnikarma is selected because it goes deep into the fascia and spreads the heat uniformly and cosmetically good as there will be no scarring of tissues. A Pilot study was done using  acupuncture needles and diathermic cautery which showed encouraging results and may overcome the lacunas of conventional method of Agnikarma. Hence here an attempt is made to develop and evaluate the efficacy of modified method of Agnikarma.
Aims and objectives:
To evaluate the efficacy of Suchividdha Agnikarma in the management of Snayugatha Vata Vis-À-Vis Tennis Elbow
To compare the efficacies of Suchividdha Agnikarma and Panchaloha Shalaka in the management of Snayugatha Vata Vis-À-Vis Tennis Elbow.

 Materials and methods:

  SOURCE OF DATA:

Literary source: Classical Ayurvedic literature, contemporary texts, journals and websites related to the disease, drugs and procedure will be reviewed and documented for the present study

.

Drug source:  Accupuncture needles used for the study trials will be purchased from the Pharmacy of JSS Ayurveda Medical College hospital, Mysuru

     Panchaloha Shalaka will be procured from the department of PG studies in Shalyatantra, JSS Ayurveda medical college and hospital, Mysuru, Karnatka.

 

Sample source: 40 patients diagnosed with Tennis elbow fulfilling the inclusion criteria will be selected from OPD and camp conducted at JSS Ayurveda Hospital, Mysuru.

 

METHOD OF COLLECTION OF DATA


 Study design: An open-labelled controlled randomized clinical trial.
 
 40 subjects diagnosed with after proper examinations and investigations, fulfilling the inclusion

 criteria will be selected & categorized into 2 groups of 20 each for the study. 

 
 Group A: 20 subjects, Suchividdha Agnikarma will be  done.
 
 Group B:  20 subjects, Agnikarma with Panchaloha Shalaka will be done.

 
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