Phase 3 N=220 Randomized Quadruple-blind Treatment

Efficacy of Shinabro in Hand Osteoarthritis

Hand Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT01910116 ↗

Enrolled (actual)

220

Serious AEs

2.3%

Results posted

Dec 2015

Primary outcome: Primary: AUSCAN Pain Change at 4 Weeks From Baseline — -9.0; -2.2 units on a scale — p=0.014

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Shinbaro (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Seoul National University Hospital
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY AUSCAN Pain Change at 4 Weeks From Baseline	-9.0; -2.2	0.014 sig
SECONDARY AUSCAN Pain Score at 8 Weeks From Baseline	-13.4; -2.2	0.011 sig
SECONDARY AUSCAN Pain Score at 12 Weeks From Baseline	-14.6; -8.0	0.053
SECONDARY AUSCAN Pain Score at 16 Weeks From Baseline	-15.6; -4.4	0.014 sig
SECONDARY AUSCAN Stiffness at 4 Weeks Change From Baseline	-9.0; -6.0	0.728
SECONDARY AUSCAN Stiffness at 8 Weeks Change From Baseline	-12.0; -6	0.229
SECONDARY AUSCAN Stiffness at 12 Weeks Change From Baseline	-14.0; -11.0	0.194
SECONDARY AUSCAN Stiffness at 16 Weeks Change From Baseline	-10.0; -8.0	0.347
SECONDARY AUSCAN Function Change at 4 Weeks From Baseline	-6.8; -3.7	0.122
SECONDARY AUSCAN Function Change at 8 Weeks From Baseline	-9.7; -4.8	0.097
SECONDARY AUSCAN Function Change at 12 Weeks From Baseline	-11; -2.9	—
SECONDARY AUSCAN Function Change at 16 Weeks From Baseline	-9.9; -4.8	0.050
SECONDARY Patient Global Assessment, Change From Baseline	-10.0; -8.5	0.221
SECONDARY Patient Global Assessment, Change From Baseline	-10.0; -8.5	0.221
SECONDARY Patient Global Assessment, Change From Baseline	-10.0; -8.5	0.221
SECONDARY Patient Global Assessment, Change From Baseline	-10.0; -8.5	0.221
SECONDARY Physician Global Assessment, Change From Baseline	-12; -6.5	0.126
SECONDARY Physician Global Assessment, Change From Baseline	-12; -6.5	0.126
SECONDARY Physician Global Assessment, Change From Baseline	-12; -6.5	0.126
SECONDARY Physician Global Assessment, Change From Baseline	-12; -6.5	0.126
SECONDARY Tender Joint Count, Change From Baseline	-2.0; -1.0	0.186
SECONDARY Tender Joint Count, Change From Baseline	-2.0; -1.0	0.186
SECONDARY Tender Joint Count, Change From Baseline	-2.0; -1.0	0.186
SECONDARY Tender Joint Count, Change From Baseline	-2.0; -1.0	0.186
SECONDARY Swollen Joint Count, Change From Baseline	0; 0	0.252
SECONDARY Swollen Joint Count, Change From Baseline	0; 0	0.252
SECONDARY Swollen Joint Count, Change From Baseline	0; 0	0.252
SECONDARY Swollen Joint Count, Change From Baseline	0; 0	0.252
SECONDARY Acetaminophen Rescue	4; 2; 105; 104	0.683
SECONDARY Acetaminophen Rescue	4; 2; 105; 104	0.683
SECONDARY Acetaminophen Rescue	4; 2; 105; 104	0.683
SECONDARY Acetaminophen Rescue	4; 2; 105; 104	0.683
SECONDARY Number of OMERACT-OARSI Responder	55; 40	0.060
SECONDARY Number of OMERACT-OARSI Responder	55; 40	0.060
SECONDARY Number of OMERACT-OARSI Responder	55; 40	0.060
SECONDARY Number of OMERACT-OARSI Responder	55; 40	0.060

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01910116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.