| CTRI Number |
CTRI/2025/08/093946 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Homeopathic medicine for knee pain and swellings in adult |
|
Scientific Title of Study
|
Comparing the effects of two succussion against ten of pre-defined
homoeopathic medicines in managing pain of knee osteoarthritis in adult:
A double-blind, randomized, controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1326-5415 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAGANNATH DAS |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, 12, Gobinda Khatick Road, TANGRA,
Kolkata
WEST BENGAL
700046
India |
| Phone |
7427908775 |
| Fax |
|
| Email |
jdas6461@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JAGANNATH DAS |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, 12, Gobinda Khatick Road, TANGRA,
WEST BENGAL
700046
India |
| Phone |
7427908775 |
| Fax |
|
| Email |
jdas6461@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PULAKENDU BHATTACHARYA |
| Designation |
Reader |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, 12, Gobinda Khatick Road, TANGRA, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
8442992147 |
| Fax |
|
| Email |
drpulakendu@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12 Gabinda khatick Road, Kolkata |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gabinda khatick Road, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
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 |
| JAGANNATH DAS |
D N De Homoeopathic Medical College and Hospital |
PG-1 and Medicine OPD, 12, Gabinda Khatick Road, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL |
7427908775
jdas6461@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of D N De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized homeopathic medicines (within Arnica Montana, Bryonia Alba, Calcarea Carbonica, Rhus Toxicodendron, Thuja Occidentalis, Natrium Muriaticum, Pulsatilla, Sulphur) of centesimal potencies (CH) with ten succussions. Along with Concomitant care |
B. Comparator arm: This arm will receive homoeopathic medicine of centesimal potencies which prepare with ten succussions. Each dose will consist of 4 globules (no. 40) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorisation using HOMPATH and RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm.
Concomitant care: Distribution of the post-intervention variable will be checked between groups. All the enrolled patients will receive advices on general management which includes ice cube massage over the painful knee(s), static quadriceps exercise (isometric knee extension, isometric knee flexion, straight leg raise, heel raise) use of knee cap or braces (if required), avoid bending knees and sitting on floor, avoid lifting heavy weights, weight loss if obese etc.. Duration of therapy: 3 months |
| Intervention |
Individualized homeopathic medicines (within Arnica Montana, Bryonia Alba, Calcarea Carbonica, Rhus Toxicodendron, Thuja Occidentalis, Natrium Muriaticum, Pulsatilla, Sulphur) of centesimal potencies (CH) with two succussions. Along with Concomitant care |
Experimental arm: Intervention is planned as administering indicated homoeopathic medicines of centesimal potencies which prepare with two succussions. Each dose will consist of 4 globules (no. 40) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorisation using HOMPATH and RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm.
Concomitant care: Distribution of the post-intervention variable will be checked between groups. All the enrolled patients will receive advices on general management which includes ice cube massage over the painful knee(s), static quadriceps exercise (isometric knee extension, isometric knee flexion, straight leg raise, heel raise) use of knee cap or braces (if required), avoid bending knees and sitting on floor, avoid lifting heavy weights, weight loss if obese etc.. Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 50-70 years
2.Participants of either sex or transgender.
3.Diagnosed knee OA as per American College of Rheumatology clinical or radiographic classification criteria
a.Knee pain
b.Age above 50
c.Stiffness lasting less than 30 minutes
d.Crepitus during knee motion
4.Participants who are familiar with the treatment or have past experience with it. For example being prepared for "homoeopathic aggravation" and being informed of the available treatment choices for the illness conditions through the Patient Information Sheet
5.Physicians of d.n.de.homoeopatic medical college and hospital outpatient (OPD) they will prescribe individualised homoeopathic medicine in cases of osteoarthritis knee pain considering the totality of symptom and miasmatic analysis. If the selected medicine is in the pre-defined project medicine list then only patient will be enrolled
|
|
| ExclusionCriteria |
| Details |
1.Not providing with written informed consent of participation.
2.severe knee joint deterioration.
3.Non-ambulant patients.
4.Intra-articular injections within 2 weeks before study entry.
5.Transplanted knees.
6.Other than osteoarthritis, self-reported joint conditions include inflammatory joint illness, particular arthropathy, gout and or hyperuricaemia significant axis deviations or instabilities joint or skin infections and lower limb joint prosthesis.
7.Recent significant knee surgery within last 6 months.
8.Benign tumours and malignant tumours.
9.Patient suffering from active or chronic, systemic or local infection or disease.
10.Patients who are too sick for consultation.
11.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
12.Pregnancy, puerperal women and lactating mother.
13.Self-reported immune-compromised state, AIDS, hepatitis etc.
14.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
15.Alcoholism, tobacco chewing, smoking, and or substance abuse and or dependence in any form (TAPS tool)
16.Simultaneous participation in any other clinical trial.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
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 Osteoarthritis outcome score- 12 (KOOS-12) Questionnaire |
Knee injury Osteoarthritis outcome score- 12 (KOOS-12) Questionnaire |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measure Yourself Medical Outcome Profile Version 2 (MYMOP-2) |
At Baseline, monthly, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
17/09/2025 |
| 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 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jdas6461@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Osteoarthritis affected about 528 million people
globally in 2019, an
increase of 113% from 1990. About 73% of people with
osteoarthritis are
over 55, and 60% of them are female[1]. With a
frequency of 365 million,
the knee is the most often impacted joint, followed
by the hip and the
hand[1] . Being primarily related to ageing, the
prevalence of OA will
steadily increase and is expected to be the single
greatest cause of
disability in the general population by 2030[2]. .
Under such
circumstances, we intend to undertake this research
project. . A double
blind, randomized (1:1), trial will be conducted on
100 adults with Knee
OA at the OPD of D. N. De Homoepathic medical
College and hospital.
To find the difference between two succussion and ten succussion of
homoeopathic medicine of centesimal potency. It has
a evidence that
centesimal potency of homoeopathic medicine produce
better result in
some previous study[3]. Assessment will be done by
evaluating the, Knee
injury and osteoarthritis outcome score-12 (KOOS-12)
[primary
outcome], Measure Yourself Medical Outcome Profile
version2.0
(MYMOP-2) [secondary outcome] every month upto 3
months.
Comparative analysis will be carried out to detect
group differences.
Introduction 595 million people around the world
suffer from degenerative arthritis in
their knees, which accounts for 7.6 % of the global
population. This
degenerative disease is caused by a breakdown of the
cartilage in knee
joint, resulting in pain, stiffness and decreased
mobility. Conventional
treatments for this condition include pain
medication, physical therapy
and, in extreme cases, surgery, but these do not
always provide lasting
relief and may carry potential side effects. While
there is demand for
homeopathy in the management of knee pain of knee
osteoarthritis but
the available evidences suggested no definitive
results. |