Efficacy of Shinabro in Hand Osteoarthritis

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

GCSB-5 ("Shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. This study is aimed at investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled, double-blind randomized trial.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Green Cross Corporation

Criteria

Inclusion Criteria:

• Age of 40 years or older

• Osteoarthritis according to ACR 1990 criteria

• Mean joint visual analog pain score (VAS) > 30mm in the preceding 48 hours

• Patients who are will to participate

Exclusion Criteria:

• Any prior surgery of hand joints

• prior history of Shinbaro use

• Intra-articular injection of glucocorticosteroid or hyaluronic acid in the preceding 3 months

• Pregnancy or active breast feeding

• Prior hypersensitivity reaction to herbal medications

• AST or ALT elevation > 3 of upper normal limit

• GRF (MDRD) < 30 mg/min/1.73m2

• Nephrotic syndrome, other signficant kidney disease

• Patients who seem not to tolerate the study at investigator's discretion

• Patients who refuse to participate