The Effects of Individualised and Complex Homeopathic Treatment in Osteoarthritis using a Novel Research desig

Phase 3

Completed

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12605000256673
• Lead Sponsor: Australian Centre for Complementary Medicine Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Subjects with a diagnosis of osteoarthritis (OA) of the hip or knee, with or without other joint involvement, as defined by:-hip/knee pain while standing, walking and/or in motion of at least 3 months duration, and-evidence of one or more of the following features in an X-ray picture: osteophytes, osteosclerosis, cysts, or joint space narrowing, and-a total WOMAC score of 30 or more at study commencement.Subjects willing to discontinue their current OA treatment for the duration of the study, commencing at least 4 weeks prior to their first visit. This includes treatment with intra-articular injections, corticosteroids, NSAIDs, non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measures.Subjects who have given their written informed consent.Female subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.

Exclusion Criteria

Severe false alignment of the axis of the knee or hip.Surgery of the knee or hip within the past 2 months or arthroscopy within the past 2 months.Administration of intra-articular injections (e.g. corticosteroids, chondroprotective agents) or treatment with any long acting osteoarthritic therapy within one month of the study commencement.Subjects who use lipolytic, fibrinolytic, anti-coagulent or anti-inflammatory agents or agents that influence platelet function (especially aspirin, aspirin-containing compounds and other NSAIDs) or complementary natural antiarthrotic agents. Infectious, inflammatory rheumatic diseases (e.g. Ross River Fever, rheumatoid arthritis).Female subjects who are pregnant or lactating.Subjects who are unwilling to comply with the study.Subjects with contra-indications to the study medication.Subjects with any condition that, in the opinion of the investigators, might interfere with the evaluation of the study objective.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Western Ontario and McMasters Universities (WOMAC) OA index for hip and knee OA, a well validated instrument. Validation studies have shown that shifts of around 20% in any of the WOMAC subscales of pain, stiffness and physical function are clinically significant.[Measured at week -4 (screening); week 0 (baseline) and week +4 (post-treatment)]

Secondary Outcome Measures

Name	Time	Method
1. Comprehensive Osteoarthritis Test[Measured daily during washout and treatment phases.];2. Short Form-12 (SF-12)[Measured pre and post-treatment.];3. Paracetamol usage[Measured daily during washout and treatment phases.]