NCT01910116

Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.

Completed Phase 2/Phase 3 Results posted Last updated 16 November 2015

What this trial tests

Phase 2/Phase 3 trial testing Shinbaro in Hand Osteoarthritis in 220 participants. Completed in 1 November 2014.

Timeline

1 September 2013

Primary endpoint
1 November 2014

1 November 2014

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	220
Start date	1 September 2013
Primary completion	1 November 2014
Estimated completion	1 November 2014
Sites	3 locations across South Korea

Drugs / interventions tested

• Shinbaro
• Placebo

Conditions studied

• Hand Osteoarthritis — all drugs for Hand Osteoarthritis →

Sponsor

Seoul National University Hospital

Who can join

18 and older, any sex, with Hand Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• AUSCAN Pain Change at 4 Weeks From Baseline
  Time frame: Baseline and 4 weeks
  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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and Tolerability of GCSB-5 for Hand Osteoarthritis: A Randomized, Controlled Trial.
   Park JK, Shin K, Kang EH, Ha YJ, et al · · 2016 · cited 13× · PMID 27449412 · DOI 10.1016/j.clinthera.2016.06.016
2. Predictors of a placebo response in patients with hand osteoarthritis: post-hoc analysis of two randomized controlled trials.
   Park JK, Ahn SH, Shin K, Lee YJ, et al · · 2021 · cited 3× · PMID 33663463 · DOI 10.1186/s12891-021-04089-9