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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014