Efficacy and Safety of Shinbaro Capsule

• Sponsor: Green Cross Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01535417
• Collaborator: (none)
• Enrollment: 198
• Arms: 2
• Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Shinbaro Capsule; Drug: Celebrex	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GCSB	Drug: Shinbaro Capsule; Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)
Active Comparator: Celebrex	Drug: Celebrex

Outcome Measures

Primary Outcome Measures

1. WOMAC change [Baseline, 12 weeks]

   WOMAC change

Secondary Outcome Measures

1. 100mm Pain VAS on walking [Baseline, 12 weeks]

   change, percent change

2. PGART [12 weeks]

3. Adverse Events [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Green Cross Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Green Cross Corporation
• ClinicalTrials.gov Identifier: NCT01535417
• Other Study ID Numbers: GCSB_P3
• First Posted: Feb 17, 2012
• Last Update Posted: Feb 17, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Green Cross Corporation: Osteoarthritis
• Additional relevant MeSH terms: Osteoarthritis; Celecoxib

Study Results

No Results Posted as of Feb 17, 2012