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Efficacy of Shinabro in Hand Osteoarthritis

NCT01910116 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2015-12-17

Study results available
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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.

Conditions

  • Hand Osteoarthritis

Interventions

DRUG

Shinbaro

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

DRUG

Placebo

The study medication and placebo were identical in appearance.

Sponsors & Collaborators

  • Green Cross Corporation

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Eun Bong Lee, MD PhD · Seoul National University College of Medicine

  • Jin Kyun Park, MD · Seoul National University Hospital

  • Yun Jong Lee, MD PhD · Seoul National Universty Bundang Hospital

  • Kichul Shin, MD PhD · SMG-SNU Boramae Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910116 on ClinicalTrials.gov