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CTRI Number  CTRI/2022/06/042995 [Registered on: 03/06/2022] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homoeopathic Treatment for Osteoarthritis 
Scientific Title of Study   A synopsis on Assessment of Likelihood Ratio of four symptoms of Medorrhinum in Patients of Osteoarthritis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sneha Basak 
Designation  Post Graduate Trainee 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block GE Sector III Salt Lake Kolkata 700106
Block GE Sector III Salt Lake Kolkata 700106
Kolkata
WEST BENGAL
700106
India 
Phone  9434952775  
Fax    
Email  snehabasak15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swapan Paul 
Designation  Assistant Professor 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block GE Sector III Salt Lake Kolkata 700106
Block GE Sector III Salt Lake Kolkata 700106
Kolkata
WEST BENGAL
700106
India 
Phone  9830148968  
Fax    
Email  drspaul.2007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swapan Paul 
Designation  Assistant Professor 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block GE Sector III Salt Lake Kolkata 700106
Block GE Sector III Salt Lake Kolkata 700106
Kolkata
WEST BENGAL
700106
India 
Phone  9830148968  
Fax    
Email  drspaul.2007@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy 
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  Block GE Sector III Salt Lake Kolkata 700106 
Type of Sponsor  Government medical college 
 
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 Sneha Basak  National Institute of Homoeopathy  Block GE Sector III Salt Lake Kolkata 700106 Department of Materia Medica Room number 18
Kolkata
WEST BENGAL 		 9434952775

snehabasak15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Homoeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M199||Osteoarthritis, unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Medorrhinum  Dose: As required for the patient Frequency: As per the need of patient Route of administration: Oral Total duration: 6 months 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients suffering from osteoarthritis of any joint verified by clinical examination and X-Ray.
2. Patient aged 35-75 year, both male and female.
3. Subjects of all socio-economic status, all religions.
4. Ability to read Bengali, Hindi and/or English.
5. Patients giving written consent to participate in this study.
6. Subjects who agree to comply with the protocol.
7. Subjects who agree to undergo laboratory investigation whenever required.
 
 
ExclusionCriteria 
Details  1. Patients below the age of 35 years.
2. Patients with increased serum uric acid level, or positive rheumatoid factors or any clinical evidence of psoriatic arthritis.
3. Patients with unstable psychiatric disorder.
4. Pregnant or lactating women.
5. Immune compromised state.
6. Substance abuse and/or dependence.
7. Uncontrolled hypertension, diabetes or any other systemic illness or life-threatening diseases.
8. Cases already undergoing homoeopathic treatment for any chronic illness.
9. Unwilling to participate or to comply with the study requirements, too unwell to take part, or declined to provide consent.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Numeric rating scale measuring intensity of pain. ‘0’ being ‘no pain’ and ‘10’ being ‘worst pain imaginable’. The patient picks or draws a circle around the number that best describes the pain intensity.   Baseline 3 months 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
EQ-5D-5L questionnaire is a quality of life questionnaire. It is used for evaluating the health status and stability of the patient. Consists of 2 pages- the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system comprises 5 dimensions- mobility, self care, usual activities, pain/discomfort, anxiety/depression.  Baseline, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/06/2022 
Date of Study Completion (India) 31/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [snehabasak15@gmail.com].

  6. For how long will this data be available start date provided 02-05-2022 and end date provided 01-05-2023?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The patient’s information shall be recorded in a standardized case taking proforma used in NIH, Kolkata (Appendix). Following preliminary screening for osteoarthritis and detailed screening using specified selection (inclusion and exclusion) criteria of the screening proforma (Appendix), eligible patients will be included in the study, followed by recording of baseline scoring data.  All eligible patients suffering from osteoarthritis, symptoms will be first matched prospectively with any of the four osteoarthritic symptoms of Medorrhinum. If similarities are detected, they will be prescribed with Medorrhinum. Otherwise, the patients were prescribed with other homoeopathic medicines as per indications. Though final selection of the medicine will be based on case taking in adherence with the standard homoeopathic guidelines, analysis and evaluation of symptoms, miasmatic diagnosis, framing symptom totality, and final conclusion with Homoeopathic Materia Medica (Appendix). Individualized dose will be selected on the basis of susceptibility of the patients. Subsequent prescriptions will be generated according to Kent’s observations, second prescription and relevant homoeopathic principles and will be recorded in follow-up sheets (Appendix). Again the scoring data will be recorded 3 months and 6months after treatment.
 
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