To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01604239
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Shinbaro Capsule Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 761 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis
Study Start Date : May 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Shinbaro Drug: Shinbaro Capsule
600mg twice a day (b.i.d) oral herbal medicine

Primary Outcome Measures :
  1. Percentage of subjects with gastrointestinal adverse events [ Time Frame: Baseline through 24 weeks ]

Secondary Outcome Measures :
  1. percentage of subjects with perforation, ulcer, bleeding [ Time Frame: baseline throgh week 24 ]
  2. percentage of subjects who withdrew due to GI AEs [ Time Frame: baseline through week 24 ]
  3. Frequency of AEs [ Time Frame: baseline throgh week 24 ]
  4. WOMAC change from baseline [ Time Frame: 24 weeks ]
  5. KKS (Korean Knee Score) change from baseline [ Time Frame: 24 weeks ]
  6. 100mm pain VAS on walking [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Minimum 19 years old
  • Kellgren stage I ~ III by ACR criteria
  • Stable osteoarthritis during 3 months
  • Be able to perform WOMAC and KKS
  • Written consent form voluntarily

Exclusion Criteria:

  • Disease of orthopaedic surgical that could affect to evaluate the efficacy
  • Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
  • Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
  • Medical history of hypersensitivity reaction against Herbal drug
  • Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
  • Occurrence of OA caused by the injury
  • Diagnosed with psychical disorder, and taking medication
  • Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
  • Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
  • Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
  • Positive in fecal occult blood test
  • Gastrointestinal tract surgery except appendectomy
  • Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
  • Participation in another clinical trials within 4 weeks
  • Not consent about using effectual contraception method during trial
  • Pregnant or lactating woman
  • Medical history of malignant tumor within 5 years
  • Investigator's judgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01604239

Korea, Republic of
Kyungpook national university hospital
Daegu, Kyungpook, Korea, Republic of
BundangCha Hospital
Bundang, Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of
Chonbul National University Hospital
Chonju, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Yeungnam University Hospital
Deagu, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Korea, Republic of
Dongguk University Medical Center
Ilsan, Korea, Republic of
Inha University Hospital
Inchun, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 130-710
Asan medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Inje University Seoul Paik Hospital
Seoul, Korea, Republic of
KyungHee University Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Study Chair: BG Lee Green Cross Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Green Cross Corporation Identifier: NCT01604239     History of Changes
Other Study ID Numbers: GCSB_P4
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Green Cross Corporation:
Herbal drug

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases