To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
- Conditions
- Osteoarthritis
- Interventions
- Drug: Shinbaro Capsule
- Registration Number
- NCT01604239
- Lead Sponsor
- Green Cross Corporation
- Brief Summary
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 761
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Shinbaro Shinbaro Capsule -
- Primary Outcome Measures
Name Time Method Percentage of subjects with gastrointestinal adverse events Baseline through 24 weeks
- Secondary Outcome Measures
Name Time Method Frequency of AEs baseline throgh week 24 WOMAC change from baseline 24 weeks percentage of subjects with perforation, ulcer, bleeding baseline throgh week 24 percentage of subjects who withdrew due to GI AEs baseline through week 24 KKS (Korean Knee Score) change from baseline 24 weeks 100mm pain VAS on walking 24 weeks
Trial Locations
- Locations (18)
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
Scroll for more (8 remaining)Kyungpook national university hospital🇰🇷Daegu, Kyungpook, Korea, Republic of