The effects of a Marinova seaweed extract on osteoarthritis

Phase 2

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12607000229471
• Lead Sponsor: Marinova Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

X-ray and clinical evidence of osteoarthritis of the kneesIn good general healthAdequate venous accessParticipants willing to discontinue their current OA (osteoarthritis) treatment for the duration of the study. This includes treatment with intra-articular injections, corticosteroids, NSAIDs (non steroidal anti inflammatory drug), non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measuresParticipants of childbearing age who agree to continue using birth control measures for the duration of the study.

Exclusion Criteria

A history of trauma associated with the affected jointRheumatoid or other inflammatory joint conditionsGoutUse of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the studyUse of anti-inflammatory agents or anti-arthritic complementary medicines 3 weeks prior to baseline and for the duration of the studyLiver function tests greater than 3 times the upper limit of normal at baselineHistory of alcohol or substance abuseFemale participants who are lactating, pregnant or planning to become pregnantParticipants who have participated in another clinical trial in the last 30 daysParticipants unwilling to comply with the study protocolAny other condition, which in the opinion of the investigators could compromise the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COAT (Comprehensive Osteoarthritis Test) - This instrument consists of four items measured on 100mm visual analogue scale (VAS) response scales: <br> - joint pain<br> - stiffness<br> - difficulties with physical activities<br> - overall symptoms[Measured daily for 12 weeks.]

Secondary Outcome Measures

Name	Time	Method
Paracetamol usage[Participants will record paracetamol usage on a daily basis in a study diary, logged daily for 12 weeks]