| CTRI Number |
CTRI/2018/10/016017 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic Treatment of difficulty in moving shoulder joint |
|
Scientific Title of Study
|
A Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Frozen Shoulder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1221-8323 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debika Biswas |
| Designation |
Postgraduate Trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
8017828168 |
| Fax |
|
| Email |
biswasdrdebika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head, Department of Pathology and Microbiology |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104
Haora
WEST BENGAL
Shubhamoy Ghosh
India |
| Phone |
8240773920 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head, Department of Pathology and Microbiology |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104
WEST BENGAL
Shubhamoy Ghosh
India |
| Phone |
8240773920 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital; Drainage Canal Road, Doomurjola, Howrah - 711104; West Bengal; India |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, 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 |
| Debika Biswas |
Mahesh Bhattacharyya Homoeopathic Medical College & Hospital |
OPD room no 4, Dept of Surgery, Drainage Canal Road, Doomurjola, Howrah 711104
Haora
WEST BENGAL |
8017828168
biswasdrdebika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homeopathic remedies in centesimal potencies. Each dose consists of 4-6 cane sugar globules 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. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Along with medicines, the intervention arm will receive joint mobility exercise and reassurance. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo |
This group will receive indistinguishable placebo. Each dose consists of 4-6 cane sugar globules moistened with 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. Along with placebo, this arm will receive joint mobility exercise and reassurance. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Cases suffering from frozen shoulder (ICD M75.02) for at least 3 months
b) Age 18-65 yrs
c) Both sexes
d) Patient having on ongoing standard or other alternative therapy for frozen shoulder, discontinued for at least 1 month
e) Literate patients; ability to read English and/or Bengali and capability and willingness to give informed consent and to comply with the study procedure |
|
| ExclusionCriteria |
| Details |
a) Cases too sick for consultation
b) Cases unwilling to stay after the doctor’s visit
c) Patients unable to read patient information sheet
d) Patients unwilling to take part or not giving consent to join the study
e) Cases willing for or requiring immediate surgical intervention or undergoing major shoulder surgery in last 6 months
f) Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
g) Patient with psychiatric disorders
h) Undergoing homoeopathic treatment for chronic disease within last 6 months
i) Self-reported immune-compromised state
j) Substance abuse and/or dependence
k) Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxford Shoulder Score (OSS) measuring intensity of pain and related quality of life |
At baseline, every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder Pain and Disability Index (SPADI) measures pain and disability |
At baseline, every month up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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 3 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| 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) |
Other (Terminated) |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Frozen shoulder is a painful, often prolonged
condition that is commonly managed in the primary care setting and requires
careful clinical diagnosis and management. Despite over a hundred years of treating frozen shoulder, the definition, diagnosis, pathology and most efficacious
treatments are still unclear. Systemic reviews of current treatments for
frozen shoulder examine the evidence base behind physiotherapy, both oral and
intra-articular steroid, hydro-dilatation, manipulation under anaesthesia
and arthroscopic capsular release. Frozen shoulder is a self-limiting condition,
lasting on average 2-3 years, and some study shows 20-50% of sufferers continue
to have pain and restricted movement beyond 3 years. The precise prevalence is unknown, thus 2-5% found
in general population. Homeopathy treatment for the said condition is claimed to be beneficial, still systematic research evidences remain compromised. In this prospective, double blind, randomised, placebo controlled, parallel arm trial aimed to evaluate the efficacy of individualised homeopathic treatment against placebo in treatment of frozen shoulder at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, 128 patients will be randomised in 1:1 ratio into either individualised homeopathic medicines or identical placebo. Oxford Shoulder Score (OSS) and Shoulder Pain and Disability Index (SPADI) will be used as the primary and secondary outcome measures respectively, measured at baseline, and every month up to 3 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals. |