| CTRI Number |
CTRI/2025/01/079790 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of Frozen shoulder |
|
Scientific Title of Study
|
Efficacy of nosodes group of medicines in cases of frozen shoulder |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Subhajit Dey |
| Designation |
PGT, Department of homoeopathic pharmacy |
| Affiliation |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Room number 06 department of Homoeopathic pharmacy academic block RBTS Government Homoeopathic Medical College and hospital Ramdayalu Muzaffarpur Bihar
Muzaffarpur BIHAR 842002 India |
| Phone |
8787684564 |
| Fax |
|
| Email |
imsubha101@gmail.com |
|
Details of Contact Person Scientific Query
Modification(s)
|
| Name |
Dr Subhajit Dey |
| Designation |
PGT, Department of homoeopathic pharmacy |
| Affiliation |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Room number 06 department of Homoeopathic pharmacy academic block RBTS Government Homoeopathic Medical College and hospital Ramdayalu Muzaffarpur Bihar
Muzaffarpur BIHAR 842002 India |
| Phone |
8787684564 |
| Fax |
|
| Email |
imsubha101@gmail.com |
|
Details of Contact Person Public Query
Modification(s)
|
| Name |
Dr Kumar Ravindra Singh |
| Designation |
Professor Department of Homoeopathic Pharmacy |
| Affiliation |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Room number 06 department of Homoeopathic pharmacy academic block RBTS Government Homoeopathic Medical College and hospital Ramdayalu Muzaffarpur Bihar
Muzaffarpur BIHAR 842002 India |
| Phone |
9334112830 |
| Fax |
|
| Email |
drkrravindra1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Muzaffarpur Bihar India 842002 |
| 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 Subhajit Dey |
RBTS Govt Homoeopathic Medical College and Hospital |
OPD 4 Surgery Dept OPD 6 Materia medica dept OPD 7 Repertory Dept RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur BIHAR |
8787684564
imsubha101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RBTS Govt 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 |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Nosodes group of Homoeopathic medicine |
Selected medicine will be given on the basis of Homoeopathic posology and follow up should be done at 15 days interval for about 1 to 3 month |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to take Homoeopathic medicines.
Patients confirming with FB53.0 criteria of ICD11.
Patients who have already had other method of treatment but now intend to undergo Homoeopathic treatment after providing a gap of 6 weeks as a washout period.
Patients having age group 35-60 years.
Patients of both Sexes.
Patients of all religions & socioeconomic status.
Patients agree to undergo some investigation if required.
|
|
| ExclusionCriteria |
| Details |
Patients with co-morbidity.
Patients taking long term treatment for any other chronic disorder.
Patients who are not willing to give consent to participate in the study.
Pregnant & lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study, it is expected that there is a constant amelioration of the complaints after administration of nosodes group of homoeopathic medicine when administered according to the homoeopathic principles. |
10 weeks to 14 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will encourage the patient for promoting homoeopathic treatment in the cases of Frozen shoulder. This study will further open various areas of research in treating patients of frozen shoulder with nosodes. |
10 weeks to 14 weeks |
|
|
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 4 |
|
Date of First Enrollment (India)
|
11/02/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Frozen Shoulder, often referred to as Adhesive capsulitis (AC), is characterized by initially painful and later progressively restricted active and passive glenohumeral (GH) joint range of motion with spontaneous complete or nearly-complete recovery over a varied period of time. It is defined as a condition of uncertain aetilogy, characterized by significant restriction of both active and passive shoulder motion that occurs in the absence of a known intrinsic shoulder disorder. The gleno-humeral joint becomes painful and stiff because of the loss of resilience of the joint capsule, possibly with adhesions between its folds. Often, there is a history of preceding trauma.
Homoeopathy has a great role in treating frozen shoulder. Homoeopathy views diseases in holistic way and evolves a therapeutic plan for its treatment in the same point. Homoeopathy treats the person as a whole. (2) It means the homoeopathic treatment focuses on the person, as well as his pathological condition.
Among other sources of homoeopathic drugs, Nosodes are medicines produced from diseased tissues or disease organs or excretions of living organisms (i.e. plants and animals) and bacterial and viral products which is prepared on the basis of homoeopathic principles. Like other homoeopathic medicines, nosodes are prescribed on the basis of symptom similarity. It is used as a constitutional medicine as well as an intercurrent remedy in chronic diseases. Nosodes have a great role in treating cases of frozen shoulder on the basis of symptoms similarity. They have great affinity for pain and stiffness in shoulder joints.
At R.B.T.S. Govt. Homoeopathic Medical College and Hospital, there are significant foot falls of patients suffering from frozen shoulder and the Nosodes group of medicines is frequently indicated for their treatment. Although various studies have been conducted on the treatment of frozen shoulder with homoeopathic medicines, there has been a lack of research specifically focusing on the Nosodes group. The homoeopathic materia medica is rich with symptoms of frozen shoulder related to Nosodes, which has inspired me to pursue research on this topic.
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