| CTRI Number |
CTRI/2026/03/105166 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO FIND OUT WHETHER INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN LM POTENCY ARE EFFECTIVE IN TREATING KNEE JOINT PAIN (PRIMARY OSTEOARTHRITIS) IN WOMEN AGED 45-60 YEARS AFTER MENOPAUSE |
|
Scientific Title of Study
|
TO ASSESS THE EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN LM POTENCY IN THE TREATMENT OF PRIMARY OSTEOARTHRITIS OF KNEE IN POSTMENOPAUSAL WOMEN IN THE AGE GROUP 45-60 YEARS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya D Inchal |
| Designation |
PG scholar |
| Affiliation |
Bhartesh Homoeopathic Medical College and Hospital Belagavi |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Opd No 1 Bharatesh Homoeopathic Medical College and Hospital sy no 16 Basavan Kudachi Extension shindoli road Belagavi 591124
Department Organon of Medicine and Homoeopathic Philosophy Opd no 1 Bharatesh Homoeopathic Medical College and Hospital sy no 16 Basavan Kudachi Extension shindoli road Belagavi 591124
Belgaum
KARNATAKA
591124
India |
| Phone |
8123896797 |
| Fax |
|
| Email |
divyainchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar R Patil |
| Designation |
Associate Professor and PG guide |
| Affiliation |
Bhartesh Homoeopathic Medical College and Hospital Belagavi |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Opd no 1 Bharatesh Homoeopathic Medical College and Hospital sy no 16 Basavan Kudachi Extension shindoli road Belagavi 591124
Belgaum
KARNATAKA
591124
India |
| Phone |
8050424354 |
| Fax |
|
| Email |
sagar.patil1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya D Inchal |
| Designation |
Pg Scholar |
| Affiliation |
Bhartesh Homoeopathic Medical College and Hospital Belagavi |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Opd no 1 Bharatesh Homoeopathic Medical College and Hospital sy no 16 Basavan Kudachi Extension shindoli road Belagavi
Bharatesh Homoeopathic Medical College and Hospital sy no 16 Basavan Kudachi Extension shindoli road Belagavi 591124
Belgaum
KARNATAKA
591124
India |
| Phone |
8123896797 |
| Fax |
|
| Email |
divyainchal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhartesh Homoeopathic Medical College and Hospital Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Divya D inchal |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy division OPD 1 Bharatesh Homoeopathic Medical College and Hospitalsy no 16 Basavan Kudachi extension Shindoli road Belagavin591124 |
| 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 Divya D Inchal |
Bharatesh Homoeopathic Medical College and Hospital Belagavi |
OPD No 1 Department of Organon of Medicine and Homoeopathic Philosophy Bharatesh Homoeopathic Medical College and Hospital sy no 16 Basavan Kudachi extension Shindoli road Belagavi 591124
Belgaum
KARNATAKA |
08123896797
divyainchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharatesh Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effectiveness of Individualized Homoeopathic medicines |
Follow up of the subjects done twice in a month for the first two months then once in a every month for fortnightly as per the requirement. Every case will be followed for next 6 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Subjects who are diagnosed on the bases of criteria established by American college
of rheumatology (ACR) criteria are included.
Subjects willing to participate in study and signed consent.
Postmenopausal women of age group 45-60 years.
|
|
| ExclusionCriteria |
| Details |
Autoimmune disorders.
Cases of complicated Osteoarthritis of Knee.
Osteoarthritis developed secondary to knee trauma or other conditions.
Subjects with metabolic disorders.
Subjects who have undergone one or both knee replacement are excluded from the
study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved Improvement of the subject with disappearance of the symptoms and
WOMAC score less than 60 with no recurrence of the complaints
Not improved No relief of the complaints or improvement in the subject with WOMAC
score more than 60 even after completion of the study |
Follow up the subjects done twice in a month for the first 2 months then once in every
month for fortnightly as per requirement
Every case will be followed for next 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
31/03/2026 |
| 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 - NO
|
|
Brief Summary
|
Title TO ASSESS THE EFFICACY OF INDIVIDUALISED HOMOEOPATHIC MEDICINE IN LM POTENCY IN THE TREATMENT OF PRIMARY OSTEOARTHRITIS OF KNEE IN POSTMENOPAUSAL WOMEN IN THE AGE GROUP 45 to 60 YEARS Subjects are selected based on inclusion and exclusion criterias Need for the study Prevalence of knee osteoarthritis is 28.3 percentage in India Sample size is 35 Type of research is interventional study Follow up of the subjects done twice in a month for the first 2 months then once in every month for fortnightly as per requirement. Every case will be followed for next 6months RESEARCH HYPOTHESIS Individualized Homoeopathic medicine in LM potency is effective in the treatment of OSTEOARTHRITIS OF KNEE IN POST MENOPAUSAL WOMEN. NULL HYPOTHESIS Individualized Homoeopathic medicine in LM potency is not effective in the treatment of OSTEOARTHRITIS OF KNEE
|