| 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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M659||Synovitis and tenosynovitis, unspecified. Ayurveda Condition: SNAYUGATAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.
)
| | 2 | Comparator Arm | Procedure | - | 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.
)
|
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|
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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.
|
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| ExclusionCriteria |
| Details |
Elbow fracture, Rheumatoid arthritis. Pregnancy and Lactation. Patients with systemic diseases like Uncontrolled diabetes mellitus, septic bursitis.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maintaining the result of primary outcome |
15th day |
|
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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. |