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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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