| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M771||Lateral epicondylitis. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (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. )
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (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 |