Randomised placebo controlled trial on the safety and efficacy of Biolane in osteoarthritis

Randomised placebo controlled trial on the safety and efficacy of Biolane in osteoarthritis of the knees and/or hips

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000024549

Enrollment

100

Registered

2006-01-19

Start date

2006-01-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biolane for a period of 18 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Total WOMAC score of >30 at baseline-x-ray and clinical evidence of osteoarthritis of the knees and/or hips.

Exclusion criteria

Gout, rheumatoid arthritis or other inflammatory joint condition-Allergy to seafood or gelatine-Use of monoamine oxidase inhibitors-Use of corticosteroids within 4 weeks prior to baseline and throughout the study-Use of aspirin or anti-inflammatory agents 3 weeks prior to baseline and for the duration of the study-Use of complementary anti-arthritic medicines 6 weeks prior to baseline and for the duration of the study-Liver function tests greater then 3 times the upper limit of normal at baseline.

Outcome results