| CTRI Number |
CTRI/2024/07/071468 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Treatment of elbow pain in fiftymillesimal potency |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine in fiftymillesimal potency in the treatment of tennis elbow:pre-post interventional 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 Rituparna Roy |
| Designation |
Post graduate trainee |
| Affiliation |
Mahesh Bhattacharyya homoeopathic medical college and hospital |
| Address |
Mahesh Bhattacharyya homoeopathic medical college and hospital. Dr.B.N Chakraborty sarani, doomurjola, Howrah.
Haora
WEST BENGAL
711104
India |
| Phone |
9593031914 |
| Fax |
|
| Email |
drrituparnabesai300@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mihir Kanti Biswas |
| Designation |
H.O.D, Department of Homoeopathic Materia Medica, |
| Affiliation |
Mahesh Bhattacharyya homoeopathic medical college and hospital |
| Address |
Mahesh Bhattacharyya homoeopathic medical college and hospital. Dr.B.N Chakraborty sarani, doomurjola Howrah.
Haora
WEST BENGAL
711104
India |
| Phone |
9051236301 |
| Fax |
|
| Email |
drmkb33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mihir Kanti Biswas |
| Designation |
H.O.D, Department of Homoeopathic Materia Medica, |
| Affiliation |
Mahesh Bhattacharyya homoeopathic medical college and hospital |
| Address |
Mahesh Bhattacharyya homoeopathic medical college and hospital. Dr.B.N Chakraborty sarani, doomurjola Howrah.
Haora
WEST BENGAL
711104
India |
| Phone |
9051236301 |
| Fax |
|
| Email |
drmkb33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya homoeopathic medical college and hospital |
|
|
Primary Sponsor
|
| Name |
DrRituparna Roy |
| Address |
Mahesh Bhattacharyya homoeopathic medical college and hospital. Dr.B.N Chakraborty sarani, doomurjola, Howrah-711104. |
| 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 Rituparna Roy |
Mahesh Bhattacharyya homoeopathic medical college and hospital |
Dr.B.N chakraborty sarani, Doomurjola, Howrah - 711104
Department of homoeopathic Materia Medica.
OPD Room no-11.
Haora
WEST BENGAL |
9593031914
drrituparnabesai300@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE of Mahesh Bhattacharyya 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 |
| Intervention |
Individualized homoeopathic medicine in FiftyMillesimal potency. |
All patients enrolled in the study will be receiving homoeopathic medicine on the basis of individualization. Mainly FiftyMillesimal potencies will be used. Selection of indicated Homoeopathic medicine on the basis of symptoms similarity in each case. Selection of proper dose and potency of fiftymillesimal scale according to the case will be given. Follow up of the case at 15th or 30th day. All medicine procured will be GMP certified. Along with medicines, the patients will receive dietary management according to individual patient’s requirements.Total study duration will be 18 months; each patient will get 3 consecutives follow up after 1 months each ,as per required. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from elbow pain associated with tenderness which diagnosed clinically
and necessary investigation if required .
Patients not taking any other medication for other complaints or same complaints. |
|
| ExclusionCriteria |
| Details |
Mental or psychiatric illness or other terminally ill patient.
Self-reported immune compromised state.
Patient requiring surgical intervention or orthopaedic correction.
patient undergoing treatment with NSAIDS.
Patients unwilling to participate in the study work. |
|
|
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
Questionnaire (PRTEEQ) |
Each patient will get follow-up
for at least 3 months at the interval of 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/07/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Tennis elbow is a inflammatory condition is also known as lateral epicondylitis (mainly lateral area involve in elbow). It is a common problem of extensor muscle of forearm, mainly affect extensor carpi radialis bravis tendon, it’s also known as tendinitis. Tennis elbow as estimated to affect 1-3% of the adult population each year, but there was no correlation with gender. High Prevalence seen in 40-50 yrs old population. Predominant symptom is intermittent pain and tenderness in the region of lateral epicondyle of humerus. Homoeopathy treating the patient on the idea of individualization. Many researches already done upon tennis elbow in specific homoeopathic medicine. My intension is to study effect of individualization homoeopathic medicine on fiftymillesimal scale in case of tennis elbow including pain associated with tenderness. Numerous patients visit with complaints of pain and tenderness in elbow due to various causes in the OPDs of Mahesh Bhattacharyya Homoeopathic College and Hospital including those discontinued with the modern medications. I took interest to show the response of individualized Homoeopathic medicines in improvement of symptoms in case of tennis elbow using fiftymillesimal potency. primary outcome measure is patient rated tennis elbow evaluation (PTREE) questionnaire. Total study duration will be 18 months; each patient will get 3 consecutives follow up after 1 months each ,as per required. |