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Efficacy and Safety of Shinbaro Capsule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01535417
First received: February 12, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  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.


Condition Intervention Phase
Osteoarthritis
 Drug: Shinbaro Capsule
Drug: Celebrex
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • WOMAC change [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    WOMAC change


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 ]

Enrollment: 198
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GCSB Drug: Shinbaro Capsule
Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)
Active Comparator: Celebrex Drug: Celebrex

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01535417     History of Changes
Other Study ID Numbers: GCSB_P3
Study First Received: February 12, 2012
Last Updated: February 14, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Green Cross Corporation:
Osteoarthritis

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

ClinicalTrials.gov processed this record on May 23, 2013