Status:
COMPLETED
Efficacy of Shinabro in Hand Osteoarthritis
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Green Cross Corporation
Conditions:
Hand Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
GCSB-5 ("Shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. This study is aimed at investigating efficacy of...
Detailed Description
Osteoarthritis (OA) as a common musculoskeletal disease affects more than 30% of the elderly population. It frequently involves knees, hips, spines and hands. In hands, the distal and proximal interph...
Eligibility Criteria
Inclusion
- Age of 40 years or older
- Osteoarthritis according to ACR 1990 criteria
- Mean joint visual analog pain score (VAS) \> 30mm in the preceding 48 hours
- Patients who are will to participate
Exclusion
- Any prior surgery of hand joints
- prior history of Shinbaro use
- Intra-articular injection of glucocorticosteroid or hyaluronic acid in the preceding 3 months
- Pregnancy or active breast feeding
- Prior hypersensitivity reaction to herbal medications
- AST or ALT elevation \> 3 of upper normal limit
- GRF (MDRD) \< 30 mg/min/1.73m2
- Nephrotic syndrome, other signficant kidney disease
- Patients who seem not to tolerate the study at investigator's discretion
- Patients who refuse to participate
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01910116
Start Date
September 1 2013
End Date
November 1 2014
Last Update
December 17 2015
Active Locations (3)
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1
Seoul National Univ. Bundang Hospital
Bundang, Gyeonggi-do, South Korea, 463-870
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 110-744
3
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea, 156-707