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Efficacy and Safety of Shinbaro Capsule

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ClinicalTrials.gov Identifier: NCT01535417
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Shinbaro Capsule Drug: Celebrex Phase 3

Study Type : Interventional  (Clinical Trial)
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 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib
U.S. FDA Resources

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



Primary Outcome Measures :
  1. WOMAC change [ Time Frame: Baseline, 12 weeks ]
    WOMAC change


Secondary Outcome Measures :
  1. 100mm Pain VAS on walking [ Time Frame: Baseline, 12 weeks ]
    change, percent change

  2. PGART [ Time Frame: 12 weeks ]
  3. Adverse Events [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01535417     History of Changes
Other Study ID Numbers: GCSB_P3
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by Green Cross Corporation:
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents