Hand Osteoarthritis Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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