Efficacy and Safety of Shinbaro Capsule

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Shinbaro Capsule; Drug: Celebrex

• Registration Number: NCT01535417
• Lead Sponsor: Green Cross Corporation

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-02
• Study First Submitted: 2012-02-12
• Study First Submitted QC: 2012-02-14
• Last Update Submitted: 2012-02-14
• Study First Posted: 2012-02-17
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• age between 35 and 80
• diagnosed with Knee OA based on criteria of ACR and showed ont through I ~ III of Kellgren Stage on radiography
• wuffered constantly with Knee OA for more than 6 months prior to begining the study
• scored more than 30 on total WOMAC scale

Exclusion Criteria

• had other comorbid orthopedic disease
• had OA of index knee from significant trauma or surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GCSB	Shinbaro Capsule	-
Celebrex	Celebrex	-

Primary Outcome Measures

Name	Time	Method
WOMAC change	Baseline, 12 weeks	WOMAC change

Secondary Outcome Measures

Name	Time	Method
100mm Pain VAS on walking	Baseline, 12 weeks	change, percent change
PGART	12 weeks
Adverse Events	12 weeks