Efficacy and Safety of Shinbaro Capsule
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Osteoarthritis |
Intervention | Drug: Shinbaro Capsule Drug: Celebrex |
Phase | Phase 3 |
Sponsor | Green Cross Corporation |
Responsible Party | Green Cross Corporation |
ClinicalTrials.gov Identifier | NCT01535417 |
First Received | February 12, 2012 |
Last Updated | February 14, 2012 |
Last verified | February 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | February 12, 2012 |
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Last Updated Date | February 14, 2012 |
Start Date | May 2009 |
Estimated Primary Completion Date | December 2009 |
Current Primary Outcome Measures | WOMAC change [Time Frame: Baseline, 12 weeks] [Designated as safety issue: No]WOMAC change |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Shinbaro Capsule |
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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 |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Osteoarthritis |
Intervention | Drug: Shinbaro Capsule Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex) Drug: Celebrex |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 198 |
Estimated Completion Date | December 2009 |
Estimated Primary Completion Date | December 2009 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 35 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01535417 |
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Other Study ID Numbers | GCSB_P3 |
Has Data Monitoring Committee | No |
Information Provided By | Green Cross Corporation |
Study Sponsor | Green Cross Corporation |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | February 2012 |