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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
GCSB-5 (Shinbaro) is a mixture of six purified oriental herb extracts in a fixed ratio, namely, Saposhnikovia divaricata Schischk, Glycine max Merrill, Cibotium barometz J. Smith, Eucommia ulmoides Oliver, Achyranthes japonica Nakai, and Acanthopanax sessiliflorus Seem
The study medication and placebo were identical in appearance.
Seoul National Univ. Bundang Hospital
Bundang, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea
AUSCAN Pain Change at 4 Weeks From Baseline
Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 4 weeks
AUSCAN Pain Score at 8 Weeks From Baseline
Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline, 8 weeks
AUSCAN Pain Score at 12 Weeks From Baseline
Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline, 12 weeks
AUSCAN Pain Score at 16 Weeks From Baseline
Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 16 weeks
AUSCAN Stiffness at 4 Weeks Change From Baseline
Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline
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Time frame: Baseline and 4 weeks
AUSCAN Stiffness at 8 Weeks Change From Baseline
Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: baseline and 8 weeks
AUSCAN Stiffness at 12 Weeks Change From Baseline
Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Basline and 12 weeks
AUSCAN Stiffness at 16 Weeks Change From Baseline
Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline, 16 weeks
AUSCAN Function Change at 4 Weeks From Baseline
Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Basline and 4 weeks
AUSCAN Function Change at 8 Weeks From Baseline
Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 8 weeks
AUSCAN Function Change at 12 Weeks From Baseline
Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 12 weeks
AUSCAN Function Change at 16 Weeks From Baseline
Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 16 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 4 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 8 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 12 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 16 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: baseline and 4 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 8 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 12 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 16 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 4 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 8 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 12 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 16 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 4 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 8 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 12 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline
Time frame: Baseline and 16 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: Baseline 4 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: 4 weeks and 8 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: 8 weeks and 12 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: 12 weeks and 16 weeks
Number of OMERACT-OARSI Responder
Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Time frame: Baseline and 4 weeks
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Time frame: Baseline and 8 weeks
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Time frame: Baseline and 12 weeks
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Time frame: Baselie and 16 weeks