Efficacy of Shinabro in Hand Osteoarthritis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01910116
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 2013
Completion date	November 2014

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.