RecruitingACTRN12610000877088

A randomised controlled trial of 'arthritis relief plus' for osteoarthritis of the knee

A randomised placebo controlled trial of 4jointz for the symptoms of osteoarthritis of the knee

Sponsor

Arthritis Relief Plus Pty. Ltd.

Enrollment

140 participants

Start Date

Sep 9, 2010

Study Type

Interventional

Conditions

Osteoarthritis of the knee

Summary

This study aims to determine the efficacy of arthritis relief plus for knee osteoarthritis pain. THis is a mix of 20 natural therapies. The design is randomised and double blind for 3 months followed by a one month wash out in 140 patients with significant knee pain due to arthritis.

Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Inclusion Criteria10

American Collegeof Rheumatology (ACR) criteria for knee osteoarthritis*
Knee pain and at least 3 of 6
Age > 50 years
Stiffness < 30 minutes
Crepitus
Bony Tenderness
Bony enlargement
No palpable warmth
Pain visual analogue scale >40mm
Age >50

Exclusion Criteria4

Other forms of arthritis
Xray showing Osteoarthritis Research Society International (OARSI) grade 3 joint space narrowing (JSN)
Significant knee injury within last 6 months
Inability to sign provide informed consent

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Interventions

4JOINTZ is a novel combination of synergistic blend of standardised botanical extracts. It is topically applied and massaged directly into the joint(s). Approximately 3 grams or less than half a tea

4JOINTZ is a novel combination of synergistic blend of standardised botanical extracts. It is topically applied and massaged directly into the joint(s). Approximately 3 grams or less than half a teaspoon is massaged into the knee joint 3 times a day for a period of 12 weeks.