| CTRI Number |
CTRI/2024/03/064363 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| 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 treatment for chronic shoulder pain |
|
Scientific Title of Study
|
Management of chronic shoulder pain in adults with individualized homoeopathic medicines: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-1138 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sikha Kisku |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College & Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
7679320024 |
| Fax |
|
| Email |
sikhakisku1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Sarkar |
| Designation |
Head |
| Affiliation |
D.N.DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dept. of Anatomy, D. N. De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9903701819 |
| Fax |
|
| Email |
sanjibsarkar1102@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Sarkar |
| Designation |
Head |
| Affiliation |
D.N.DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dept. of Anatomy, D. N. De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9903701819 |
| Fax |
|
| Email |
sanjibsarkar1102@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata 700046 |
| 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 Sikha Kisku |
D N De Homoeopahic Medical College and Hospital |
Dept. of Repertoy, OPD no. PG3 and room no 1 (Medicine), 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
7679320024
sikhakisku1989@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 & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus
concomitant care |
Each dose will consist of 4 cane sugar globules no. 40
moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be decided depending upon the individual requirement of the cases. All sundry items will be procured from a Good
Manufacturing Practice (GMP)
certified firm. All the enrolled patients will receive advice on concomitant care, i.e., shoulder mobilizing exercise, standing arm swing, shoulder pass-through, pendulum stretch, finger crawling on the wall, reverse fly, rotation with a dumbbell, cross arm stretch, shoulder raise, shoulder roll, ear to shoulder movement, hot and cold fomentation etc. Duration of therapy: 3 months |
| Intervention |
Individualized homeopathic
medicines in centesimal
potencies plus concomitant care |
Intervention is planned as
administering indicated
homoeopathic medicines in
centesimal potencies (cH). Each dose will consist of 4 cane sugar globules no. 40
moistened with the indicated
medicine (preserved in 90% v/v
ethanol), to be taken orally on clean tongue with empty
stomach; dosage and repetition
depending upon the individual
requirement of the cases.
Patients will be advised to
refrain from handling the
globules or from eating,
drinking, smoking or brushing
teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive advice on concomitant care, i.e., shoulder mobilizing exercise, standing arm swing, shoulder pass-through, pendulum stretch, finger crawling on the wall, reverse fly, rotation with a dumbbell, cross arm stretch, shoulder raise, shoulder roll, ear to shoulder movement, hot and cold fomentation etc. Duration of therapy: 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with chronic shoulder pain for 3 months or more according to ICD 10 (M25.51)
2. Patients already undergoing regular oral or topical analgesics or NSAID therapy for chronic shoulder pain, provided the medications are stopped completely at least 2 weeks prior study entry
3. Age between 18 and 65 years
4. Patients of either both sex and transgender
5. Participants having prior experience or knowledge of the treatment; e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet. |
|
| ExclusionCriteria |
| Details |
1. Not providing informed consent of participation
2. Radiological evidence of shoulder joint fracture or dislocation
3. Non-ambulant patients
4. Intra-articular injections within 2 weeks before study entry
5. Cases willing for or requiring immediate surgical intervention or already underwent any major shoulder joint surgery within last 3 months, 6. When the shoulder pain is due to any invasive malignant disease or neoplasia
7. Patients suffering from active local infection of shoulder joint, 8.Patients who are too sick for consultation
8. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life
9. Pregnancy, puerperal women and lactating mother
10. Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool)
11. Self-reported immune-compromised state, AIDS, hepatitis etc.
12. Undergoing homoeopathic treatment for any chronic disease within last 6 months
13. Simultaneous participation 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 |
| Quick DASH (disabilities of the arm, shoulder, and hand) |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder pain and disability index (SPADI) |
Baseline, every month, up to 3 months |
| Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2) |
Baseline, every month, up to 3 months |
| 10 cm visual analog scale measuring intensity of pain |
Daily, via online survey, upto 3 months |
|
|
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)
|
01/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [sikhakisku1989@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - N/A
|
|
Brief Summary
|
Chronic shoulder pain is a major public health problem in adults of developing countries. Chronic shoulder pain is considered amongst the most common musculoskeletal conditions throughout the world. The use of homoeopathic medicines is prevalent globally to treat the condition , rigorous research evidence in support of homoeopathy in shoulder pain has remained compromised. Under such circumstances , we intend to undertake this research to explore the effects of individualized homoeopathic medicine in comparison with placebo in the management of chronic shoulder pain in adults .This double-blind, randomized(2:1) placebo controlled trial using individualized homoeopathic medicines along with placebo will be conducted on 40 participants suffering from chronic shoulder pain in- patient departments of D. N. De homoeopathic medical college and hospital. Primary outcome will be measured by using Quick Dash scores & secondary outcome will be measured by using SPADI, MYMOP-2 score and VAS pain scale .All the outcomes will be measured every month up to 3 months. Group differences will be calculated on the intention-to-treat and per-protocol samples. Results will be published in scientific journals. |