| CTRI Number |
CTRI/2026/01/100740 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Agnikarma with Suvranashalaka] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The Effect of Agnikarma Therapy By Using A Gold Probe for the Treatment of Tennis Elbow. |
|
Scientific Title of Study
|
A Single Arm Clinical Trial To Study The Effect Of Agnikarma With Suvarna Shalaka As An Ashukari Chikitsa In The Management Of Snayugata Vata With Special Reference To Lateral Epicondylitis. |
| 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 Saumya Suresh Mishra |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalyatantra SMBT
Ayurved College and Hospital
Nandi Hills Dhamangaon Ghoti
Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
8788181573 |
| Fax |
|
| Email |
saumya19999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Badhe |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalyatantra SMBT
Ayurved College and Hospital
Nandi Hills Dhamangaon Ghoti
Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9689339928 |
| Fax |
|
| Email |
adkpc74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saumya Suresh Mishra |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalyatantra SMBT
Ayurved College and Hospital
Nandi Hills Dhamangaon Ghoti
Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
8788181573 |
| Fax |
|
| Email |
saumya19999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Saumya Suresh Mishra |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumya |
SMBT Ayurved College and Hospital |
OPD NO.4 Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA |
8788181573
saumya19999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M709||Unspecified soft tissue disorder related to use, overuse and pressure. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita, Sutrasthana, Chapter 12, Procedure details: Agnikarma is performed with Suvarna Shalaka over Lateral Epicondylitis.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients in the age group of 20 to 60 years of either sex.
2) Patients will be included if they experience sign and symptoms of snayugatavata at Karpur Sandhi.
3) Patients will be included by confirming positive cozens test and mills maneuver. |
|
| ExclusionCriteria |
| Details |
1) A patient will be excluded if he or she was currently receiving corticosteroid injection during the past months.
2) Patients which are contraindicated for Agnikarma.
3) Patients who have completed participation in any other clinical trial during last 6 months
4) Patient which are known cases of DM, IHD,HTN, Malignancies, Dyslipidemia, Chronic Renal Failure & Endochronological disorders will be excluded
5) Cervical spine or any other upper limb dysfuction.
6) Neurological disease and osteoporosis. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
the role of Agnikarma with Suvarna Shalaka as an Ashukari
Chikitsa in the management of Snayugata Vata with special reference to
lateral epicondylitis based on subjective and objective criteria |
Within 1 Day of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
TITLE - A SINGLE ARM CLINICAL TRIAL TO STUDY THE EFFECT OF AGNIKARMA WITH SUVARNA SHALAKA AS AN ASHUKARI CHIKITSA IN THE MANAGEMENT OF SNAYUGATA VATA WITH SPECIAL REFERENCE TO LATERAL EPICONDILYTIS.
INTRODUCTION - In Ayurveda, Snayugatavata is classified under Vatavyadhi. In this condition, the Vata Dosha becomes vitiated and localizes in the Snayu (ligaments and tendons) of the body. This results in symptoms such as Shoola (pain), Kampa (tremors), and Stambha (stiffness) in the Kurpara Sandhi (elbow joint). A similar condition in modern medicine is Lateral Epicondylitis, commonly known as Tennis Elbow. It occurs due to repetitive strain or excessive workload, leading to microtears or rupture of the tendon at the elbow joint, which causes pain and a reduced grip strength. The prevalence of Lateral Epicondylitis is 3%. According to the Lakshanas we can correlate it to Snayugatavata and lateral epicondylitis. In modern science, there are two line of treatment for Tennis elbow which includes : A) medicinal (steroids) B) surgical Therefore this study is selected for the research purpose, to avoid adverse reaction of long term use of steroids. Gold has one of the highest thermal conductivity among metals. It delivers heat more uniformly and deeply into the affected tissues compared to other . And Suvarna Shalaka has yet not been studied for Agnikarma procedure in Snayugatavata as an Ashukari Chikitsa to fulfill this knowledge gap. there is a need to study Agnikarma as an Ashukari Chikitsa in Snayugat Vata. Vas scale will be applied for clinical study and final conclusion will be drawn.
Null Hypothesis(H0): Agnikarma with Suvarna Shalaka is not effective as an Ashukari Chikitsa in the management of Snayugatavata with special reference to lateral Epicondilytis.
Alternate Hypothesis(H1): Agnikarma with Suvarna Shalaka is effective as an Ashukari Chikitsa in the management of Snayugatavata with special reference to lateral Epicondilytis.
Size Sample: The sample size was calculated by the formula and the prevalence rate of the disease. Hence the calculated sample size is 51, but for more accuracy of study sample size will be taken 60 patients.
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