Efficacy study of Faulding's sea cucumer extracts in osteoarthritis.

Randomised, double-blind, three armed, placebo controlled trial comparing the safety and efficacy of sea cucumber extract, sea cucumber extract with Boswellia extract and placebo in adults with osteoarthritis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000484640

Enrollment

129

Registered

2005-09-23

Start date

2000-06-05

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

Cucumaria frondosa extract 1000mg or Cucumaria frondosa extract 1000mg plus 400mg Boswellia serrata extract over 11 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 85 Years

Healthy volunteers

Inclusion criteria

1) Diagnosis of OA of the hip or knee. 2) Willing to discontinue all current OA treatment for the study duration commencing 4 weeks prior to baseline.

Exclusion criteria

1) Severe false alignment of the knee or hip2) Surgery or arthroscopy of the knee or hip within 2 months of baseline3) Infectious or inflammatory rheumatic disease4) Reliance on the use of lipolytic, fibrinolytic, anti-coagulant or anti-inflammatory agents5) A history of trauma associated with the affected joints6) Any condition that in the opinion of the investigator might interfere with the evaluation of the study objective.

Outcome results