A comparative clinical study to evaluate the role of individualised homoeopathic remedy with and without Chelidonium Q in the management of Osteoarthritis
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- WOMAC score
Study Overview
Brief Summary
Background: Osteoarthritis (OA) is a long-term joint condition thatcauses pain, stiffness, and reduced mobility, often affecting a person’s dailylife. Homoeopathy offers a gentle, holistic approach to managing such chronicconditions. Chelidonium Majus Q, a well-known homoeopathic mother tincture, hastraditionally been used to address hepatic disorders, this study explores howeffective Chelidonium Majus Q when given along with individualized Homoeopathicmedicine in review with Homoeopathic Materia medica is in relieving thesymptoms of Osteoarthritis of the knee.
Objective: This study is intended to determine and evaluate theeffectiveness of Chelidonium Majus in mother tincture form in reduction of painand stiffness in patients with Osteoarthritis, and to compare the WOMAC scores and Visual Analogue Scale of both groups to determine statistical significance.
Methodology: This Randomized clinical study of 60 cases involving twogroups, 30 cases each. GROUP 1 cases managed with individualized homoeopathicmedicine and Chelidonium majus Q, GROUP 2 cases managed with individualizedhomoeopathic medicine only. The results obtained will be statisticallyanalyzed and evaluated by using Paired ‘T’ test in order to determine theeffectiveness of Chelidonium majus Q in symptomatic relief of Osteoarthritis ofthe knee. This study provides evidence to say that, Chelidonium majus in theform of mother tincture have significant results in lowering the pain and jointstiffness, and improves the mobility of the affected knee in Osteoarthritispatients.
Expected Outcome: This study anticipates demonstrating that Patientsadministered with Chelidonium majus q along with Individualized homoeopathicmedicine will show significant reduction in pain and stiffness of joint, which is assessed through WOMAC scale and Visual Analogue Scale
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 50.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients diagnosed with Osteoarthritis of Knee with Western Ontario McMaster Universities Arthritis Index score of more than
- •Patients with Visual Analogue Scale of more than 4.
Exclusion Criteria
- •Rheumatoid arthritis, psoriatic arthritis, Gout.
- •patients with any other disease affecting mobility, patients with severe systemic illness such as liver and kidney dysfunction, diabetes, cardio vascular disease, patients on long term NSAIDS or steroids,.
Outcomes
Primary Outcomes
WOMAC score
Time Frame: Baseline and after 12 weeks
Secondary Outcomes
- Visual Analogue Score, joint stiffness and physical functions of the patient(baseline ,2weeks, 4 weeks, 6 weeks,8weeks, 10 weeks, 12 weeks)