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CTRI Number  CTRI/2026/02/105019 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   INDIVIDUALIZED HOMOEOPATHIC MEDICINES FOR OA KNEE JOINT. 
Scientific Title of Study   EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN 50-MILLESIMAL POTENCY IN PERI AND POST MENOPAUSAL WOMEN SUFFERING FROM OSTEOARTHRITIS OF KNEE WITH ITS MIASMATIC ANALYSIS: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1335-0936  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ishrat Parween 
Designation  Post Graduate Trainee 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy,Organon OPD(Room No.19),265, 266, Acharya Prafulla Chandra Road

Kolkata
WEST BENGAL
700009
India 
Phone  7998194470  
Fax    
Email  ishratparween799@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayabrata Pal 
Designation  Associate Professor,Department of Organon of Medicine and Homoeopathic Philosophy 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy,Organon OPD(Room No.19),265, 266, Acharya Prafulla Chandra Road

Kolkata
WEST BENGAL
700009
India 
Phone  7679752020  
Fax    
Email  dr.jayabratapal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayabrata Pal 
Designation  Associate Professor,Department of Organon of Medicine and Homoeopathic Philosophy 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy,Organon OPD(Room No.19),265, 266, Acharya Prafulla Chandra Road

Kolkata
WEST BENGAL
700009
India 
Phone  7679752020  
Fax    
Email  dr.jayabratapal@gmail.com  
 
Source of Monetary or Material Support  
The Calcutta Homoeopathic Medical College and Hospital, 265, 266 Acharya Prafulla Chandra Road, Kolkata 700009  
 
Primary Sponsor  
Name  The Calcutta Homoeopathic Medical College and Hospital 
Address  265, 266, Acharya Prafulla Chandra Road, Kolkata 700009 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ishrat Parween  The Calcutta Homoeopathic Medical College and Hospital.  Department of Organon of Medicine,OPD No.19,265, 266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL 		 7998194470

ishratparween799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,The Calcutta 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: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebos plus concomitant care  This group received placebo, identical in appearance with the verum, for a period of 3 months. In placebo, one non-medicated globule of no.10 is to be dissolved in 100 ml of distilled water, and few drops of rectified spirit are added to it and mixed well to make 7 doses or as required. After 10 uniform forceful downward strokes to the vial, each dose of 15 ml is to be added in 35-40 ml normal water in a clean cup and to be stirred well, from the mixture 5ml is to be taken orally on clean tongue in empty stomach. Dosage and repetition will be done depending upon the individual requirement of the case.Duration 3months 
Intervention  Individualized homoeopathic medicines in 50- millesimal potency with concomitant care  The intervention was planned as administering indicated homeopathic medicines in 50-millesimal potencies, as decided appropriate to the case or condition. In 50-millesimal potencies, one medicated globule of no.10 is to be dissolved in 100 ml of distilled water, and few drops of rectified spirit are added to it and mixed well to make 7 doses regularly or a required. After 10 uniform forceful downward strokes to the vial, each dose of 15ml is to be added in 35-40 ml normal water in a clean cup and to be stirred well, from the mixture 5ml is to be taken orally on clean tongue in empty stomach. Dosage and repetition will be done depending upon the individual requirement of the case. Patients were advised to refrain from eating, drinking, smoking, or brushing their teeth within 30 min of taking the medicine. All medicines and sundry items were procured from a Good Manufacturing Practice (GMP) certified from, India. The duration of therapy is 3 months. Both medicines and placebos were re-packed in identical glass bottles and labeled with code, name of medicine, potency, and were dispensed according to a random number list. A single medicine was prescribed on each occasion, considering the presenting symptom totality, clinical history, constitutional features, and repertorization by appropriate repertories, using HOMPATH ZOMEO 3.0®/Radar/other standard software when required. Materia medica was consulted and consensus was arrived at among three homeopaths for the final selection of the medicine and dosage. Provision was made to change the medicines or potencies and adjust the dosage in subsequent visits, in compliance with homeopathic principles.Duration 3 months 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.Female patients of peri and post-menopausal age suffering from osteoarthritis of knee joints (ICD-11 FA01.0 for primary, FA01.1 for post-traumatic, and FA01.2 for other secondary type) since last 3 months.
2.American College of Rheumatology 2019 diagnostic criteria of knee osteoarthritis using history, physical examination and radiographic findings pain in knee and one of the following-(a) age over 50 years, (b) morning stiffness less than 30 min, and (c) crepitus on active motion and osteophytes on x-ray.
 
 
ExclusionCriteria 
Details  1.Severe degeneration of knee joint with mark joint narrowing, varus, or valgus deformity of knee; as evidenced by imaging or other evidences and requiring surgical intervention.
2.Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, hyperuricemia and/or gout, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs).
3.Intra-articular injections within 2 weeks before study entry.
4.Transplanted knees.
5.Non ambulant patient.
6.Obese patient (body mass index 30.0 or more).
7.Recent significant knee surgery within last 6 months.
8.Vulnerable population - unconscious, ambulatory, too seek for consultation, differently abled, terminally or critically ill patients, mentally incompetent people.
9.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
10.Pregnant and puerperal women, lactating mothers.
11.Severe osteoporosis and already diagnosed case of osteoarthritis of knee joint.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Knee injury and osteoarthritis outcome score (KOOS)  At baseline, every month, up to 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
EQ-5D-5L questionnaire   At baseline, every month, up to 3 months  
 
Target Sample Size   Total Sample Size="167"
Sample Size from India="167" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/03/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  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 [ishratparween799@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
    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  

Osteoarthritis (OA) is a prevalent, progressively developing joint disorder that notably affects middle-aged and older individuals, substantially impacting their quality of life and ability to perform daily activities. Postmenopausal women are considered a high-risk group for OA due to physiological changes associated with menopause, including hormonal fluctuations, as well as other factors such as age-related joint degeneration and heightened pain sensitivity. This 3-months, double-blind, randomized (2:1), placebo-controlled trial of individualized homoeopathic medicines against placebos will be carried out at The Calcutta Homoeopathic Medical College & Hospital on 167 participants with Osteoarthritis(OA) of knee joint. Primary outcome is Knee injury and osteoarthritis outcome score (KOOS); secondary outcome is EQ-5D-5L questionnaire ; all to be measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.

 
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