CTRI Number	CTRI/2021/02/031453 [Registered on: 22/02/2021] Trial Registered Prospectively
Last Modified On:	08/03/2023
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Homeopathy
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Modification(s)	Homeopathy in knee pain
Scientific Title of Study	Individualized homeopathic medicines in treatment of knee osteoarthritis: Evaluation by double-blind, randomized, placebo-controlled, feasibility trial
Secondary IDs if Any	Secondary ID  Registry  U1111-1264-6487  UTN
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Soumya Bhattacharyya  Address  Research OPD, Room no 12, 12, Gobinda Khatick Road, Tangra, Kolkata Kolkata WEST BENGAL 700046 India  Phone  9836998171   Fax     Email  soumya.bh@gmail.com
Details Contact Person Scientific Query	Name  Prof Dr Shyamal Kumar Mukherjee  Address  Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata Kolkata WEST BENGAL 700046 India  Phone  9831113383   Fax     Email  shyamalmukhergee@gmail.com
Details Contact Person Public Query	Name  Prof Dr Shyamal Kumar Mukherjee  Address  Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata Kolkata WEST BENGAL 700046 India  Phone  9831113383   Fax     Email  shyamalmukhergee@gmail.com
Source of Monetary or Material Support	D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046
Primary Sponsor	Name  D N De Homoeopathic Medical College and Hospital  Address  12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046  Type of Sponsor  Government medical college
Details of Secondary Sponsor	Name  Address  None  NA
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Soumya Bhattacharyya  D. N. De Homoeopathic Medical College and Hospital  Research OPD, Room no 12, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 Kolkata   9836998171 soumya.bh@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethical Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Osteoarthritis of knee, unspecified
Intervention / Comparator Agent	Type  Name  Details  Intervention  Individualized homeopathic medicines  It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition. Each dose shall consist of 4 globules (no. 30) 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. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Route of administration: Oral. All patients will be given general advices on using knee caps, ice cube massage over the affected joint(s), static quadriceps or isometric knee exercises, avoid bending knees and sitting on floor, lifting heavy weights, etc. Duration of therapy: 2 months.  Comparator Agent  Placebo  Placebo, identical in appearance with and indistinguishable from the medicine. Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm. Route of administration: Oral. All patients will be given general advices on using knee caps, ice cube massage over the affected joint(s), static quadriceps or isometric knee exercises, avoid bending knees and sitting on floor, lifting heavy weights, etc. Duration of therapy: 2 months.
Inclusion Criteria	Age From  50.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  1. Age 50-70 years 2. Patients of either sex 3. Diagnosed knee osteoarthritis as per American College of Rheumatology (ACR) clinical or radiographic classification criteria a) Knee pain b) At least 1 of 3: age more than 50 years, 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. Patients who are literate and capable of filling the questionnaire and providing written informed consent.
ExclusionCriteria	Details  1. Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee (>12°), evidenced by imaging or other evidences and requiring surgical intervention 2. Non-ambulant patients 3. 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) 4. Intra-articular injections within 2 weeks before study entry 5. Transplanted knees 6. Recent significant knee surgery within last 6 months 7. Patients who are too sick for consultation 8. Unwilling to take part and not giving consent to join the study 9. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life 10. Pregnancy, puerperium and lactation 11. Substance abuse and/or dependence 12. Self-reported immune-compromised state, and 13. Undergoing homoeopathic treatment for any chronic disease within last 6 months.
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 and after 2 months
Secondary Outcome	Outcome  TimePoints  EQ-5D-5L questionnaire and VAS score  At baseline and after 2 months
Target Sample Size	Total Sample Size="40" Sample Size from India="40"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India)	24/02/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	None yet, to be published
Brief Summary Modification(s)	Degenerative joint disease is one of the common forms of arthritis worldwide, found mostly in elderly people, and can worsen over time if not treated properly. This study was undertaken to evaluate the effects of individualized homeopathic medicines (IHMs) against placebos in the treatment of knee osteoarthritis (OA). This double-blind, randomized (1:1), placebo-controlled, feasibility trial was conducted on 40 patients suffering from knee OA in the outpatient departments of a Government Homoeopathic Medical College and Hospital in West Bengal. Participants were randomized to receive either IHMs (n=20) or identical-looking placebos (n=20), along with concomitant care advice given mutually to all the participants. Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure; and derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS, EQ-5D-5L questionnaire and visual analog scale (VAS) were the secondary outcomes; all measured at baseline, and after 2 months of treatment. Group differences and effect sizes (Cohen’s d) were measured with unpaired t-tests using an intention-to-treat approach. P values less than 0.05 were set as statistically significant. Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the COVID-19 pandemic and lockdown. All the group differences were statistically significant favoring IHMs against placebos in all the KOOS subscales and EQ-5D-5L components – symptoms (P < 0.001), pain (P = 0.002), activities of daily living (P < 0.001), sports or recreation (P = 0.016), quality of life (P = 0.002), WOMAC stiffness (P < 0.001), WOMAC pain (P < 0.001), EQ-5D-5L questionnaire score (P < 0.001) and EQ-5D-5L VAS scores (P < 0.001), with medium to large effect sizes. Sulphur, Arnica montana, Natrium muriaticum, Medorrhinum, and Rhus toxicodendron were the most frequently prescribed medicines. No harm or serious adverse events were reported from either of the groups. IHMs showed significantly better results than placebos in the treatment of knee OA. Larger and more definitive trials are warranted with independent replications to confirm the findings.