| CTRI Number |
CTRI/2025/02/081068 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Shoulder pain in Homoeopathy |
|
Scientific Title of Study
|
UTILITY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN TREATMENT OF FROZEN SHOULDER: AN OPEN LABEL PROSPECTIVE SINGLE ARM CLINICAL 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 |
Priyamvada |
| Designation |
Postgraduate trainee |
| Affiliation |
State national Homoeopathic medical college and hospital |
| Address |
Department of homoeopathic Materia Medica, State National Homoeopathic Medical College And Hospital ,Viraj khand-1 Gomati Nagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7905518362 |
| Fax |
|
| Email |
priyamvaday1994@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Dilip Kumar Sonkar |
| Designation |
Professor |
| Affiliation |
State National Homoeopathic Medical College And Hospital, Viraj khand-1 Gomati Nagar ,Lucknow |
| Address |
Department of Physiology and Biochemistry, State National Homoeopathic Medical College And Hospital, Viraj khand-1 Gomati Nagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7398204457 |
| Fax |
|
| Email |
drdksonkar86992@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Priyamvada |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital,Viraj khand-1 Gomati Nagar, |
| Address |
Department of homoeopathic Materia Medica, State National Homoeopathic Medical College And Hospital ,Viraj khand-1 Gomati Nagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7905518362 |
| Fax |
|
| Email |
priyamvaday1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College And Hospital ,Viraj khand-1 Gomati Nagar Lucknow (UP) (226010) |
|
|
Primary Sponsor
|
| Name |
Dr. Priyamvada |
| Address |
State National Homoeopathic Medical College And Hospital,Viraj Khand-1 Gomati Nagar Lucknow (UP)(226010) India |
| Type of Sponsor |
Other [Self] |
|
|
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 Priyamvada |
State National Homoeopathic Medical College And Hospital Viraj khand-1 Gomati Nagar Lucknow (226010) |
OPD-08, Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College And Hospital, Viraj khand-1 Gomati Nagar Lucknow (226010) Lucknow UTTAR PRADESH |
7905518362
priyamvaday1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee State National 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 |
Individualize Homoeopathic Medicine |
Intervention- The individualized homoeopathic medicine
will be selected according to the totality of symptoms.
Dosage- Medicine will be given in varying potencies of
decimal/ centesimal/ millesimal scales as identified from
detailed case taking.Each dose shall consist of cane
sugar medicated with single medicine. Route-Medicine
will be administered via oral route. Dosage and
repetition will depend upon the individual requirement of
the cases as per the guidelines from organon of
medicine. The patient will be called for follow up after
every 15 days and final assessment will be done after 6
months. At every follow up after reexamining the case it
will be decided whether the patient will receive a dose of
individualized homoeopathic medicine or placebo. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female patients of frozen shoulder.
2.Age group 18 to 70 years.
3.Patient fulfilling the diagnostic criteria of frozen shoulder.
4.Patient giving written consent to participate in the study.
5.Patient scoring 13 to 130 in SPADI score will be include in this study.
|
|
| ExclusionCriteria |
| Details |
1.Case below the age of 18 and above the age of 70 years.
2.Patient not willing to participate in the study.
3.Case suffering from uncontrolled systemic illness or life-threatening disease.
4.Substance abuse and /or dependence.
5.Pregnant women, lactating mothers, and women who are planning for pregnancy.
6.Patient opting for other approaches for managing shoulder pain such as surgical intervention and use of pain-relieving medication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the SPADI score at baseline and after 6 month of treatment to know the utility of individualized homoeopathic medicines. |
12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To short list medicines commonly found to be useful in management of frozen shoulder. |
12 weeks, 24 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This is an open-label, single-arm, prospective, international study designed to assess the effectiveness of individualized homeopathic medicine in managing frozen shoulder. Homeopathic remedies will be prescribed in decimal, centesimal, or millesimal potencies, based on detailed case-taking and repertorization. The SPADI (Shoulder Pain and Disability Index) score will be calculated both pre- and post-treatment, and the differences will be compared and analyzed. Frozen shoulder is a clinical condition characterized by the spontaneous onset of shoulder pain and a gradual loss of both active and passive shoulder movement. The etiology of the condition remains unclear. Studies suggest that up to 40% of patients experience persistent, though generally mild, symptoms beyond three years, and 15% face long-term disability. Given the incidence and prevalence of this condition, frozen shoulder has become a significant burden, affecting patients’ daily activities. While treatments such as NSAIDs, physical therapy, and steroids are commonly used, the most effective approach remains uncertain. Homeopathy, being a non-invasive and gentle healing science, aims to offer lasting relief and could prove highly beneficial in managing this challenging condition. This study is therefore being undertaken to investigate how individualized homeopathic treatment, based on the totality of the patient’s symptoms, can offer a valuable solution for managing frozen shoulder. |