| CTRI Number |
CTRI/2025/12/099488 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic Management For Tennis Elbow Pain |
|
Scientific Title of Study
|
UTILITY OF INDIVIDUALISED HOMOEOPATHIC
MEDICINES IN MANAGING PAIN OF TENNIS ELBOW BY
USING PRTEE SCALE DOUBLE ARM RANDOMISED
CONTROL TRIAL |
| 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 Shivang Pandya |
| Designation |
PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoepathic medical college and Hospital , Parul University |
| Address |
OPD room number 110 , Jawaharlal Nehru Homoeopathic medical college and Hospital , Parul University , Waghodiya , Vadodara , Gujarat , India , 391760
Vadodara GUJARAT 391760 India |
| Phone |
7359774419 |
| Fax |
|
| Email |
drshivangpandya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kirtida Desai |
| Designation |
BHMS , MD Homoeopathy , Head of Department of Practice of medicine |
| Affiliation |
Jawaharlal Nehru Homoepathic medical college and Hospital , Parul University |
| Address |
PG Department of Practice of medicine Jawaharlal Nehru Homoeopathic medical college and Hospital , Parul University , Waghodiya , Vadodara , Gujarat , India , 391760
Vadodara GUJARAT 391760 India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivang Pandya |
| Designation |
PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoepathic medical college and Hospital , Parul University |
| Address |
OPD room number 110 , Jawaharlal Nehru Homoeopathic medical college and Hospital , Parul University , Waghodiya , Vadodara , Gujarat , India , 391760
Vadodara GUJARAT 391760 India |
| Phone |
7359774419 |
| Fax |
|
| Email |
drshivangpandya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College and Hospital , Parul University , Waghodiya , Vadodara , Gujarat , India , 391760 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical College and Hospital , Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital , Parul University , Waghodiya , Vadodara , Gujarat , India , 391760 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shivang Pandya |
Jawaharlal Nehru Homoeopathic Medical College and Hospital , Parul University , Waghodiya , Vadodara , Gujarat , India , 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivang Pandya |
Jawaharlal nehru homoeopathic medical college and Hospital |
OPD Room number 102 , Jawaharlal Nehru Homoeopathic medical college and hospital Parul university , Limda , Waghodiya , Vadodara , Gujarat 391760 , India Vadodara GUJARAT |
7359774419
drshivangpandya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlala Nehru Homoeopathic medical college Institutional ethic committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M771||Lateral epicondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
On The Basis of Totality Of Symptoms of Patient Selection of potency and Repetition as per Susceptibility and According to Homoeopathic principles and Follow up will be conducted every 7 days for 3 months minimum 6 follow ups |
| Comparator Agent |
Placebo |
Non medicated Globules as Placebo is given to one group by Simple Randomisation using computer allocation software |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of Tennis elbow done with Cozen’s test / mill’s test.
Age group between 20 to 60 years.
Patients who are willing to participate & give written informed consent |
|
| ExclusionCriteria |
| Details |
Patients having fractures,trauma or surgery of affected limb.
Patients with comorbidities Rheumatoid arthritis , gout , DM , Thyroid illness.
Other major illness such as renal , hepatic or cardiac diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study utility of individualised homoeopathic medicines in managing pain of Tennis Elbow in comparison with placebo. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor improvement in pain by using NRS score in Tennis Elbow treated by
individualised homoeopathic medicines and placebo.
Physiotherapy will be done in both arms.
To compare the efficacy of individualized homoeopathic medicine versus placebo over 3 months.
To assess the severity and outcome of patients before and after individualised
homoepathic medicines in cases of Tennis Elbow by Using PRTEE scale. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/01/2026 |
| 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="9" 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
|
Tennis elbow also termed as Lateral Epicondylitis, is a common musculoskeletal disorder characterised by pain and tenderness over the lateral aspect of the elbow , primarily due to overuse or repetitive strain of the extensor carpi radials brevis tendon.Tennis elbow is a common musculoskeletal disorder affecting about 1 to 3 percentage of the general population worldwide, with peak incidence between 35 and 50 years of age. It results primarily from repetitive overuse of the wrist extensors, leading to pain and tenderness over the lateral epicondyle. The condition is frequently observed not only in athletes but also among individuals involved in repetitive occupational tasks such as typing, carpentry, or housekeeping. In India, the reported prevalence is around 4.5 per 1,000 persons per year, with localized studies showing rates of 5 to 7 percentage among young adults and active workers. Though data specific to Gujarat are limited, recent local surveys have indicated a prevalence of about 6 percentage among college students, highlighting the growing occupational and lifestyle-related burden of this condition.A recent article titled Tennis Elbow and its Homoeopathic Management Valavan & Sharma, 2022 discusses the theoretical basis, materia medica, and anecdotal or case-based reports of using homeopathic remedies for tennis elbow.While it points out potential benefits of homeopathy in reducing pain and aiding recovery, the article does not provide data from rigorous clinical trials, such as randomized, placebo-controlled designs, nor does it quantify treatment effects using strongly validated pain assessment tools over time.Thus, the gap is that no published randomized, double-arm, placebo-controlled clinical trial assessing individualised homoeopathic medicines exists for lateral epicondylitis using outcome measures such as the Numeric Rating Scale NRS and Patient-Rated Tennis Elbow Evaluation PRTEE. Your proposed study aims to fill this by providing high-quality empirical evidence of individualised homeopathy in managing pain and functional impairment in tennis elbow.The PRTEE, formerly known as the Patient-Rated Forearm Evaluation Questionnaire PRFEQ, is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis . The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales , pain subscale and function subscale
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