| CTRI Number |
CTRI/2025/12/098629 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in the treatment of pain in outside region of elbow |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine selected using synthesis repertory for the treatment of tennis elbow - An open label interventional prospective clinical 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 Rajashree Swain |
| Designation |
PGT Trainee |
| Affiliation |
National Institute of Homoeopathy, Kolkata kata |
| Address |
OPD Room No 10, Department of Repertory, National Institute of Homoeopathy, Block GE Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9439784173 |
| Fax |
|
| Email |
rajashree6248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokanath Behera |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy, Kolkata |
| Address |
OPD Room No 10, Department of Repertory, National Institute of Homoeopathy, Block GE Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9477747610 |
| Fax |
|
| Email |
lokanath.nih@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lokanath Behera |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy, Kolkata |
| Address |
OPD Room No 10, Department of Repertory, National Institute of Homoeopathy, Block GE Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9477747610 |
| Fax |
|
| Email |
lokanath.nih@gov.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal, 700106, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, 700106,West Bengal, India |
| 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 Rajashree Swain |
National Institute of Homoeopathy |
OPD Room No 10, Department of Repertory, Block GE Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL |
09439784173
rajashree6248@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M658||Other synovitis and tenosynovitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
Indicated individualized homoeopathic medicine will be prescribed after the repertorisation of the case using rubrics with in synthesis repertory. Dose and frequency of the selected medicine will be as per the susceptibility of the case. Follow up will be done monthly till 6 months from the baseline. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed patients suffering with Tennis Elbow between 18 to 60 years of age and of any sex and religion.
2. Patients who are willing to fill the questionnaire and informed consent form.
3. Patient who can able to read and understand either Bengali or Hindi or English.
4. Patients willing to take part in the study and for regular follow ups.
|
|
| ExclusionCriteria |
| Details |
1. Patients having any surgery, trauma or fracture in the elbow region within the previous 3 months.
2. Patients having systemic inflammatory medical condition.
3. Patient is under local corticosteroid injection within the previous 3 months or oral glucocorticoids or any other medicine for the tennis elbow.
4. Pregnant and lactating women.
5. Patients having any terminal disease condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient rated tennis elbow evaluation score |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient rated tennis elbow evaluation score |
Baseline and 6 month |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/12/2025 |
| 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 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
|
1.Tennis Elbow is characterized by pain, inflammation or
degeneration of tendons of common extensor origin especially Extensor Carpi
Radialis Brevis (ECRB) and Extensor Communis Digitorum (ECD) at Lateral
Epicondyle of Humerus. 2. Samples will be selected following preliminary and detailed screening using specified selection criteria. 3. Inclusion and exclusion criteria are strictly followed. 4. After consideration of dropout cases, a minimum 40 patients will be enrolled for the study. 5. Case-taking will be done as per the strict homoeopathic principle. 6. Baseline scoring will be taken using PRTEE 7. Analysis and evaluation of each case will be done. 8. Miasmatic analysis will be done. 9. Repertorization will be done in Synthesis Repertory. 10. Final selection of the remedy will be done after consultation with Materia Medica. 11. Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles. 12. General (non-medicinal) management including appropriate diet and regimen will be advised. 13. Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. 14. Baseline data will be compared with the data obtained in 6th month. 15. The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter. |