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.
ConditionOsteoarthritis
InterventionDrug: Shinbaro Capsule
Drug: Celebrex
PhasePhase 3
SponsorGreen Cross Corporation
Responsible PartyGreen Cross Corporation
ClinicalTrials.gov IdentifierNCT01535417
First ReceivedFebruary 12, 2012
Last UpdatedFebruary 14, 2012
Last verifiedFebruary 2012

Tracking Information[ + expand ][ + ]

First Received DateFebruary 12, 2012
Last Updated DateFebruary 14, 2012
Start DateMay 2009
Estimated Primary Completion DateDecember 2009
Current Primary Outcome MeasuresWOMAC change [Time Frame: Baseline, 12 weeks] [Designated as safety issue: No]WOMAC change
Current Secondary Outcome Measures
  • 100mm Pain VAS on walking [Time Frame: Baseline, 12 weeks] [Designated as safety issue: No]change, percent change
  • PGART [Time Frame: 12 weeks] [Designated as safety issue: No]
  • Adverse Events [Time Frame: 12 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety of Shinbaro Capsule
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionOsteoarthritis
InterventionDrug: Shinbaro Capsule
Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)
Drug: Celebrex
Study Arm (s)
  • Experimental: GCSB
  • Active Comparator: Celebrex

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment198
Estimated Completion DateDecember 2009
Estimated Primary Completion DateDecember 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
GenderBoth
Ages35 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01535417
Other Study ID NumbersGCSB_P3
Has Data Monitoring CommitteeNo
Information Provided ByGreen Cross Corporation
Study SponsorGreen Cross Corporation
CollaboratorsNot Provided
Investigators Not Provided
Verification DateFebruary 2012