CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 220 enrolled
Drug / intervention
Shinbaro +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01910116
NCT01910116Phase 3Completed
CompareCT.gov

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

Seoul National University Hospital·interventional·Posted Jul 29, 2013·Updated Dec 17, 2015

In Brief

A Phase 3 clinical trial evaluating Shinbaro and Placebo for Hand Osteoarthritis. Completed, enrolled 220 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHand Osteoarthritis
CountriesSouth Korea
CollaboratorsGreen Cross Corporation

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 29, 2013
Enrollment StartSep 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.9 years ago

Interventions

Shinbarodrug

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

Placebodrug

The study medication and placebo were identical in appearance.