Efficacy of individualized homoeopathic medicines selected using polarity analysis in reducing the pain of knee osteoarthritis in adults: A double-blind, randomized, placebo-controlled trial
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
U1111-1304-0918
UTN
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Tuhina Parveen
Designation
Postgraduate Trainee
Affiliation
D.N. De Homoeopathic Medical College and Hospital
Address
Dept. of Repertory, OPD room no. PG3 and Medicine (room 1), 12, Gobinda Khatick Road, Tangra
Kolkata WEST BENGAL 700046 India
Phone
7890837153
Fax
Email
imtuhinaparveen@gmail.com
Details of Contact Person Scientific Query
Name
Dr Subhranil Saha
Designation
Lecturer
Affiliation
D. N. De Homoeopathic Medical College and Hospital
12,Gobinda Khatick Road, Tangra, Kolkata, West Bengal, India
Kolkata WEST BENGAL 700046 India
Phone
8777382128
Fax
Email
drsubhranilsaha@hotmail.com
Source of Monetary or Material Support
D.N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Primary Sponsor
Name
D. N. De Homoeopathic Medical College and Hospital
Address
12, Gobinda Khatick Road, Tangra, Kolkata 700046
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 Tuhina Parveen
D. N. De Homoeopathic Medical College and Hospital
Dept of Repertory, room no. PG3, OPD no. 1 (Dept. of Medicine), 12, Gobinda Khatick Road, Tangra, Kolkata 700046 Kolkata WEST BENGAL
7890837153
imtuhinaparveen@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Instituitional Ethics Committee of D. N. De Homoeopathic Medical College & Hospital
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
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
Identical-looking placebos and concomitant care
This arm will receive a placebo, identical in appearance to the verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on a clean tongue with an empty stomach; dosage and repetition will depend upon the individual requirements of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm. All the enrolled patients of both groups will receive concomitant care in the form of general management, which will include 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 caps or braces (if required), avoiding bending knees and sitting on the floor, avoiding lifting heavy weights, weight loss if obese, etc., as recommended by the consultant yoga therapist. Both groups will be advised to take foods rich in vitamin C (Indian gooseberry, citrus fruit, such as limes and oranges) & vitamin E (sunflower, safflower, and soybean oil, sunflower seeds, peanuts, and red bell pepper), carotenes (such as carrots, spinach, lettuce, tomatoes, sweet potatoes, and broccoli), seasonal fruits and vegetables, whole-meal cereals, legumes, nuts, and fish, which can be effective in decreasing the disease progression. All the dietary recommendations will be customized according to the socio-economic and cultural backgrounds of the participants and as instructed by the dietician. Duration of treatment: 3 months.
Intervention
Individualized homoeopathic medicines in centesimal potencies plus concomitant care
Intervention is planned as administering the indicated homoeopathic remedy in centesimal potencies, as decided appropriate to the case or condition. On a centesimal scale, each dose shall 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 a clean tongue with an empty stomach; dosage and repetition will depend upon the individual requirements 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 them. All the medicines and other items will be procured. All the enrolled patients of both groups will receive concomitant care in the form of general management, which will include 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 caps or braces (if required), avoiding bending knees and sitting on the floor, avoiding lifting heavy weights, weight loss if obese, etc., as recommended by the consultant yoga therapist. Both groups will be advised to take foods rich in vitamin C (Indian gooseberry, citrus fruit, such as limes and oranges) & vitamin E (sunflower, safflower, and soybean oil, sunflower seeds, peanuts, and red bell pepper), carotenes (such as carrots, spinach, lettuce, tomatoes, sweet potatoes, and broccoli), seasonal fruits and vegetables, whole-meal cereals, legumes, nuts, and fish, which can be effective in decreasing the disease progression. All the dietary recommendations will be customized according to the socio-economic and cultural backgrounds of the participants and as instructed by the dietician. Duration of treatment: 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 (ICD 11- FA01) as per American College of Rheumatology (ACR) clinical/radiographic classification criteria
a. Knee pain
b. At least 1 of 3: age more than 50 yrs., stiffness less than 30 min, and crepitus on knee motion.
c. Osteophytes on knee x-ray
4. Patients already undergoing regular oral or topical analgesics or NSAID therapy for painful episodes of OA, provided the medications are stopped completely at least 2 weeks prior study entry.
5. At least 5 polar symptoms and 10 indicated remedies under a rubric.
6. Participants having prior experience or knowledge of the treatment. e.g.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
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 (more than 12°), evidenced by imaging or other evidences and requiring surgical intervention.
3. Non-ambulant patients.
4. Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, hyperuricaemia 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 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. Unwilling to take part and not giving consent to join the study
12. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
13. Pregnancy, puerperal women and lactating mother.
14. Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
15. Self-reported immune-compromised state, AIDS, hepatitis etc.
16. Undergoing homoeopathic treatment for any chronic disease within last 6 months.
17. 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
Modified Pain Detection (mPDQ) questionnaire
Every month up to 3 months
Secondary Outcome
Outcome
TimePoints
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Every month up to 3 months
Measure Yourself Medical Outcome Profile (MYMOP-2)
Every month up to 3 months
Time to resolution of pain of knee
Every week up to 3 months
Target Sample Size
Total Sample Size="90" Sample Size from India="90" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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-identification.
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan
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.
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 [imtuhinaparveen@gmail.com].
For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030? Response - Beginning 3 months and ending 5 years following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NA
Brief Summary
Osteoarthritis is a heterogeneous group of degenerative joint disease of multifactorial origin characterized by Joint space narrowing, bone spur formation, subchondral bone remodeling, deteriorating integrity and gradual loss of articular cartilage, and synovial inflammation. Knee OA is most common site for osteoarthritis accounting of approximately 20.4% of cases. Though the use of Homeopathic medicine is extensive globally and homeopathic practitioners frequently deal with this condition but efficiency of individualized homoeopathic medicines had shown conflicting results. So we intend to undertake the research to evaluate the efficacy and safety of individualized homeopathic medicines selecting upon using Polarity analysis by Heiner Frei. Thus this double-blind, randomized (2:1), placebo-controlled trial using IHMs based upon Polarity analysis along with concomitant care will be conducted upon 90 patients suffering from Knee OA in both out-patient department and in-patient departments of D. N. De Homoeopathic Medical College & Hospital. Primary outcome measure will be mPDQ , and KOOS, MYMOP-2, frequency of add-on paracetamol and/or NSAIDs (oral/topical), time to resolution of pain of knee will be used as secondary outcome measures. All outcomes will be measured up to 3 months. Group differences will be analyzed statistically. Results will be published in scientific journal.