Efficacy of anti-coagultion, lipolytic and anti-inflammatory phytotherapeutic agents for the treatment of osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12605000630617
• Lead Sponsor: Blackmores Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Subjects with a diagnosis of painful OA of the hip or knee, with or without other joint involvment, as defined by:i) hip or knee pain while standing, walking and/or in motion of at least 3 months duration, and ii) evidence of one or more of the following features in an X-ray picture taken in the past 6 months: osteophytes, cysts or joint space narrowingSubjects with profiles defined by (Triglycerides > 1mmol/L and (ECLT (euglobulin clot lysis time) >190min or Cholesterol >5.9mmol/L)) or (Diastolic blood pressure >85mmHg and <110mmHg).Subjects willing to discontinue their current OA treatment for the study duration, commencing 2 weeks pripor to their first visit (29 weeks).

Exclusion Criteria

History of joint replacementSurgery on the knee or hip within the past 12 months or arthroscopy within the past 6 months.Adminstration of any long-acting osteoarthritis therapy in the previous 3 months.Subjects will contra-indications to the study medication or to paracetamol (inlcuding allergies)Subjects with a Diastolic blood pressure of >=100mmHg or systolic blood pressure >= 180mmHg at any stage of the studySubjects on any medication known to interact with anti-hypertensive or lipid lowering drugs or to influence platelet function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in WOMAC score from baseline to 12 weeks of treatment.[At baseline and after 12 weeks of treatment.]

Secondary Outcome Measures

Name	Time	Method
The change in laboratory lipid status.[From baseline to endpoint (12 weeks of treatment).];The change in laboratory coagulation status.[From baseline to endpoint (12 weeks of treatment).]