To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
NCT ID: NCT01604239
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
761 participants
INTERVENTIONAL
2012-05-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Shinbaro
Shinbaro Capsule
600mg twice a day (b.i.d) oral herbal medicine
Interventions
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Shinbaro Capsule
600mg twice a day (b.i.d) oral herbal medicine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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BG Lee
Role: STUDY_CHAIR
GC Biopharma Corp
Locations
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Kyungpook national university hospital
Daegu, Kyungpook, South Korea
BundangCha Hospital
Bundang, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Hospital
Deagu, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Dongguk University Medical Center
Ilsan, , South Korea
Inha University Hospital
Inchun, , South Korea
Chonbul National University Hospital
Jeonju, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Inje University Seoul Paik Hospital
Seoul, , South Korea
KyungHee University Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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References
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Ha CW, Park YB, Kyung HS, Han CS, Bae KC, Lim HC, Park SE, Lee MC, Won YY, Lee DC, Cho SD, Kim CW, Kim JG, Kang JS, Lee JH, Choi ES, Seon JK, Lee WS, Bin SI. Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study. J Ethnopharmacol. 2016 Aug 2;189:310-8. doi: 10.1016/j.jep.2016.05.031. Epub 2016 May 16.
Other Identifiers
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GCSB_P4
Identifier Type: -
Identifier Source: org_study_id