Efficacy of Shinabro in Hand Osteoarthritis

Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.

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.

Osteoarthritis (OA) as a common musculoskeletal disease affects more than 30% of the elderly population. It frequently involves knees, hips, spines and hands. In hands, the distal and proximal interphalangeal and the first carpometacarpal joints are affected, leading often to significant disability and limitation in the daily activity. The chronic progressive nature of the disease requires a life-long treatment. The mainstay treatment of hand OA targets pain control. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used. However, they are frequently associated with significant gastrointestinal side effects including gastritis, peptic ulcer diseases, and bleeding, especially with long term use. Further, they do not ameliorate pain completely, requiring additional medications such as acetaminophen or opioid-based analgesics.

Shibaro is a mixture of purified oriental herbs consisting of Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, and Eucommiae Cortex. These herbs have been used for the treatment of diverse inflammatory conditions in Chines traditional medicine. All 6 herbs show an excellent safety profile and their anti-inflammatory and analgesic effects have been studied in both animals and humans. As such, given the excellent safety profile, anti-inflammatory and analgesic effects, Shinbaro might be ideal in the treatment of OA.

This study will investigate the efficacy and safety of Shinbaro in the treatment of hand OA in a placebo-controlled, randomized, double-blind, multi-center trial.

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