Efficacy of Shinabro in Hand Osteoarthritis

Seoul National University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Hand Osteoarthritis

Treatments

Drug: Shinbaro

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01910116

GC6102F

Details and patient eligibility

About

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.

Full description

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.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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