| CTRI Number |
CTRI/2025/11/098062 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic treatment for reducing pain and improving movement in patients with frozen shoulder |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines in fifty millesimal potency on pain, disability and quality of life in patients of adhesive capsulitis: A 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. Shilpi Bhowmik |
| Designation |
Post Graduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, 1st floor,Room no 3 Mahesh Bhattacharya Homoeopathic Medical College and Hospital, Sailen Manna Sarani, Drainage Canal Road, Dumurjola, Howrah
Haora WEST BENGAL 711104 India |
| Phone |
8348300710 |
| Fax |
|
| Email |
shilpibhowmik07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrTrishita Basu |
| Designation |
BHMS, M.D.(Hom) (Reader) |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, 1st floor, Room No 3, Mahesh Bhattacharya Homoeopathic Medical College and Hospital, Sailen Manna Sarani, Drainage Canal Road, Dumurjola, Howrah, 71104
Haora WEST BENGAL 711104 India |
| Phone |
8334941727 |
| Fax |
|
| Email |
drtrishita85@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrTrishita Basu |
| Designation |
BHMS, M.D.(Hom) (Reader) |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, 1st floor,Room No 3 Mahesh Bhattacharya Homoeopathic Medical College and Hospital, Sailen Manna Sarani, Drainage Canal Road, Dumurjola, Howrah, 711104
Haora WEST BENGAL 711104 India |
| Phone |
8334941727 |
| Fax |
|
| Email |
drtrishita85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical Collegeand Hospital, Sailen Manna Sarani, Drainage Canal Road, Dumurjola, Howrah, 711104, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Sailen Manna Sarani, Drainage Canal Road, Dumurjola, 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 Shilpi Bhowmik |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Department of Homoeopathic Materia Medica,1st floor, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,Sailen Manna Sarani, Drainage Canal Road, Dumurjola, Howrah, 711104 Haora WEST BENGAL |
08348300710
shilpibhowmik07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, 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: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Invidualized Homoeopathic Medicine |
Individualized Homoeopathic Medicines (IHMs) are prescribed to all patients with adhesive capsulitis, and the indicated remedy is administered in 50 millesimal potency according to the patient’s symptoms, modalities, constitution, and general condition;A single No. 10 size–1 globule, medicated with the selected potency, will be placed into 100 mL of distilled water. To this mixture, one-fourth volume of alcohol will be added, and the preparation will be thoroughly mixed to obtain a medicated solution (Mist.).
From this stock solution, sixteen equal doses will be prepared. Each dose is to be administered on an empty stomach in the early morning. Before dispensing each dose, the bottle will be given ten succussions to ensure uniform dynamization. The intervention will be continued for 3months.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from shoulder pain, stiffness, restricted active and passive movement of shoulder joint persists for 6months.
Patients with an age group of 40-70years.
Patient who can give voluntary informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with substance abuse or dependence, those with X-ray findings indicating other shoulder pathologies such as fractures, dislocations or osteoarthritis, patients with psychiatric disorders, individuals with uncontrolled co-morbid conditions like endocrine disorders or other life-threatening illnesses affecting quality of life, and patients already under homoeopathic or concomitant treatment for any other chronic disease were excluded. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of individualized homoeopathic medicines in reduction of pain, disability associated with Adhesive capsulitis by using Shoulder Pain and Disability Index (SPADI). |
Baseline, at every month upto 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study aims to assess the improvement in the range of motion—specifically external rotation, flexion and abduction—using a goniometer scale, and to evaluate the effectiveness of individualized homoeopathic medicines on health-related quality of life in patients with adhesive capsulitis using the EQ-5D-5L questionnaire. |
Baseline, at every month 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
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2025 |
| 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 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
|
Adhesive capsulitis is one of the most prevalent shoulder disorders seen in OPD. It should be prioritized since patients are unable to perform due to stiffness and pain. Her everyday tasks, including clothing and grooming, involved tying up stuff behind her back for months or years. Many female and male patients in their sixth decade of life seek treatment at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital for this symptomatology. Numerous research have evaluated the effectiveness of individualized homoeopathic medicines using self-evaluation questionnaires such as SPADI.On the other hand, it has been seen all the literatures where previous studies had done, the potency selection of homoeopathic medicine is mainly centesimal potency. As well as in our daily practice we don’t utilise fifty millesimal potency fully. We will try to ascertain the effectiveness of individualized homoeopathic medicine in fifty millesimal potency for the assessment of pain and disability in patients suffering from Adhesive capsulitis. |