| CTRI Number |
CTRI/2025/09/094332 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment for Knee Pain in Adults |
|
Scientific Title of Study
|
An exploratory randomized controlled pilot trial comparing the effects of individualized homoeopathic medicines in LM and centesimal potencies in managing the pain of knee osteoarthritis in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-4098 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mobasshir Iqbal |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9883978722 |
| Fax |
|
| Email |
imobasshir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mobasshir Iqbal |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9883978722 |
| Fax |
|
| Email |
imobasshir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Satyajit Naskar |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
8981859153 |
| Fax |
|
| Email |
satya.naskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda 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 |
| Dr Mobasshir Iqbal |
D N De Homoeopathic Medical College and Hospital |
Dept. of Organon of Medicine, OPD no. 11(PG1), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL |
9883978722
imobasshir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized Homoeopathic medicines in centesimal potencies plus concomitant care |
This arm will receive centesimal scale of potencies. 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.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 Homoeopathic medicines in LM potencies plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in 50 millesimal scale of potency. The medicine is administered in 120 ml bottle of aqua dist. with one 10no. globule mixed in it with few drops of rectified spirit. Each dose is administered after giving 10 strokes and mixing in half glass of water(containing 120ml) and taking 1 teaspoon from it in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the bottle or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the medicine. 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.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 to 70 years
2.Participants of either sex or transgender
3.Diagnosed knee oa according to American College of Rheumatology(ACR) clinical or radiographic classification criteria such as knee pain, age more than 50 years, morning stiffness less than 30 minutes, crepitus on active motion, osteophytes on knee xray
|
|
| ExclusionCriteria |
| Details |
1. Not providing with written informed consent of participation.
2. Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee, evidenced by imaging or other evidences and requiring surgical intervention, joint or skin infection, joint prostheses of the lower limbs.
3. Non-ambulant patients.
4. 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)
5. Intra articular injections within 2 weeks before study entry
6. Transplanted knees.
7. Recent significant knee surgery within last 6 months
8. Benign tumors and malignant tumors.
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. Tobacco chewing and or smoking, alcoholism and or any form(s) of substance abuse and or dependence.
14. Self reported immune compromised state, AIDS, hepatitis etc.
15. Undergoing homoeopathic treatment for any chronic disease within last 6 months.
16. Simultaneous participation in any other clinical trial.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To address the feasibility issue of a definitive future trial |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| modified pain detection questionnaire (mPDQ) |
At baseline , every month upto 3 months |
| Intermittent and Constant Osteoarthritis Pain(ICOAP) |
At baseline , every month upto 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 [imobasshir@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 is a cause of disability that is rapidly growing among older adults, with its prevalence rising by 137% since 1990 and affecting almost half of people over 80 years of age. Chronic pain, joint stiffness, reduced mobility, and loss of independence are all symptoms of osteoarthritis. Chronic inflammation, cellular senescence, and muscle loss are aging-related mechanisms that accelerate disease progression, while obesity, menopause, and inactivity accelerate joint degeneration. Care remains fragmented and reactive, often relying on surgery, which is not suitable for many due to frailty, despite available treatments like bisphosphonates and emerging therapies like senolytics and regenerative medicine, thus emphasizing the pressing need for a comprehensive, preventative, and person-centered approach that incorporates early screening, personalized non-surgical management, mental health support, physical rehabilitation, and caregiver participation. Homeopathy may have immense potential to offer in successful treatment of pain of Knee Osteoarthritis but the available data shows contradictory results. Under such circumstances, we intend to undertake this research project to evaluate the efficacy of 50 millesimal scale of potencies and to explore the feasibility of a definitive future trial. Many studies were carried out which suggest that LM potencies offer a safe, gentle, and effective approach for managing chronic diseases. An open label, randomized (1:1), centesimal controlled trial will be conducted on 102 adults who are suffering from pain of Knee Osteoarthritis at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Modified Pain Detect Questionnaire(mPDQ) [secondary outcomes], Intermittent and Constant Osteoarthritis Pain(ICOAP)[secondary outcomes] every month up to 3 months. Comparative analysis will be carried out to detect group differences. |