| CTRI Number |
CTRI/2025/08/093760 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| 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 medicines for pain in elbow in adults. |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in the pain management of tennis elbow in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-3594 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abha Kumari |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, 12, Gobinda Khatick Road, Kolkata, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
9905501123 |
| Fax |
|
| Email |
abhabansal09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abha Kumari |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, 12, Gobinda Khatick Road, Kolkata, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
9905501123 |
| Fax |
|
| Email |
abhabansal09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangita Saha |
| Designation |
Professsor |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine,
OPD no. 11 (PG1)
12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433989717 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.N.De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
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 Abha Kumari |
D.N.De Homoeopathic Medical College and Hospital |
Dept. of Organon of Medicine, OPD no. 11(PG 1), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL |
09905501123
abhabansal09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
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 |
| Comparator Agent |
Identical-looking placebo plus concomitant care |
A placebo that looks identical to the verum will be administered to this arm. Each dose of placebo will consist of 4 cane sugar globules (no. 40), moistened with rectified spirit, to be consumed orally on clean tongue and in empty stomach, dosage and repetition will be given depending upon the individual case requirement. Similar to the experimental arm, management directions will be provided. The medicines as well as placebos will be re-packed in matching glass bottles, labelled with the medications name, potency, and code. Then, the medications will be dispensed in accordance with the random number list. Duration of therapy of each case: 3 months |
| Intervention |
Individualized homeopathic medicines plus concomitant care |
The enrolled patients of TE will be treated with IHMs. The indicated homeopathic medication will be administered in centesimal potencies as part of the proposed intervention, as decided appropriate to the case or condition. Each dose, measured in centesimal scale, must contain 4 cane sugar globules (no. 40) medicated with the indicated drug (kept in 90% v/v ethanol) to be consumed orally on clean tongue and in empty stomach; dosage and repetition will be given depending upon the individual case requirement. It will be advised to patients not to handle the globules and not to consume any food, liquids, smoke or brush their teeth within 30 minutes of taking the globules and will be asked to suck the globules instead of simply swallowing them. Every time, a single, individualized medication will be prescribed taking into account presenting totality of symptom, clinical history details, constitutional features, miasmatic expressions, repertorization with the aid of HOMPATH software in each case with due consultation of Materia Medica and due consensus among three homoeopaths. A firm accredited by Good Manufacturing Practices (GMP) will supply all medications and other items. Based on the principles of classical homoeopathy, provisions will be made for changing the medications or potencies and alter the dosage in subsequent visits as needed and such instances will be compared between groups. Duration of therapy of each case: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18 to 65 years
2. Either sex or transgender
3. Patients having lateral elbow pain for more than or equal to 12 weeks, tenderness over the lateral epicondyle, and pain on resisted wrist extension
4. Clinical diagnosis of TE confirmed by positive Cozens test and Mills test
5. Patients with ability to understand English or Hindi or Bengali
|
|
| ExclusionCriteria |
| Details |
1. Denying informed consent
2. Severe pain (NRS more than 7)
3. Patients with previous trauma and or undergone surgery of the elbow region
4. Patients who are undergoing treatment with NSAIDS during 4 weeks prior to enrolment in the study
5. Elbow pain due to peripheral nerve entrapment, cervical radiculopathy
6. Corticosteroid injection within 6 months
7. Vulnerable population unconscious, non ambulatory, too sick for, differently abled or mentally incompetent, unstable mental or psychiatric illness or other systemic diseases (e.g. uncontrolled hypertension, diabetes, thyroid diseases etc.)
8. Pregnancy, nursing mothers, and puerperal women
9. Chewing tobacco, smoking, alcoholism, substance misuse in any form, and or dependence (TAPS tool)
10. Receiving homoeopathic treatment for a chronic illness all through the previous three months
11. Simultaneously taking part in any other clinical trial
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Numeric Rating Scale (NRS) |
At baseline, monthly, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient-Rated Tennis Elbow Evaluation (PRTEE) scores |
At baseline, monthly, up to 3 months |
| Susceptibility assessment tool |
At baseline |
| Miasm checklist |
At baseline |
| Patient Response Assessment Tool after Homeopathic therapeutic (PRATHoT v 2.2) |
Monthly, up to 3 months |
| Time to clinical recovery |
Every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abhabansal09@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Tennis elbow (TE), commonly known as lateral epicondylitis, is the leading cause of musculoskeletal elbow pain, that severely impairs upper limb function. It results from repetitive forearm prono-supination and elbow extension, with risk factors including tendon deterioration and blood supply disruption. Homeopathy is one of the most frequently used complementary and alternative medicine (CAM) therapies in children as well as in adults. Limited research in tennis elbow includes a study on a complex remedy for tendinitis, one comparing Ruta graveolens to IHMs, and an underpowered trial, missing its target sample size where IHMs outperformed placebo. This study replicates a prior homoeopathic trial to validate the efficacy of individualized homoeopathic medicines in tennis elbow using a double-blind, randomized (2:1), placebo-controlled design on 96 adults with tennis elbow. Assessment will be done by evaluating the Numeric rating scale (NRS) (Primary outcome), Patient rated tennis elbow evaluation (PRTEE) (secondary outcome) every month upto 3 months. Assessment of susceptibility, miasmatic analysis and treatment outcome using PRATHoT v 2.2 tool. Comparative analysis will be carried out to detect group differences |