Clinical trial NCT01910116: Efficacy of Shinabro in Hand Osteoarthritis
Official title: Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hand Osteoarthritis
Keywords: osteoarthritis
hand
Shinbaro
GCSB-5
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
First posted: 2013-07-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled, double-blind randomized trial.

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 interphalangeal and the first carpometacarpal joints are affected, leading often to significant disability and limitation in the daily activity. The chronic progressive nature of the disease requires a life-long treatment. The mainstay treatment of hand OA targets pain control. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used. However, they are frequently associated with significant gastrointestinal side effects including gastritis, peptic ulcer diseases, and bleeding, especially with long term use. Further, they do not ameliorate pain completely, requiring additional medications such as acetaminophen or opioid-based analgesics.

Shibaro is a mixture of purified oriental herbs consisting of Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, and Eucommiae Cortex. These herbs have been used for the treatment of diverse inflammatory conditions in Chines traditional medicine. All 6 herbs show an excellent safety profile and their anti-inflammatory and analgesic effects have been studied in both animals and humans. As such, given the excellent safety profile, anti-inflammatory and analgesic effects, Shinbaro might be ideal in the treatment of OA.

This study will investigate the efficacy and safety of Shinbaro in the treatment of hand OA in a placebo-controlled, randomized, double-blind, multi-center trial.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: AUSCAN Pain Change at 4 Weeks From Baseline
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: AUSCAN Pain Score at 8 Weeks From Baseline
timeFrame: Baseline, 8 weeks
measure: AUSCAN Pain Score at 12 Weeks From Baseline
timeFrame: Baseline, 12 weeks
measure: AUSCAN Pain Score at 16 Weeks From Baseline
timeFrame: Baseline and 16 weeks
measure: AUSCAN Stiffness at 4 Weeks Change From Baseline
timeFrame: Baseline and 4 weeks
measure: AUSCAN Stiffness at 8 Weeks Change From Baseline
timeFrame: baseline and 8 weeks
measure: AUSCAN Stiffness at 12 Weeks Change From Baseline
timeFrame: Basline and 12 weeks
measure: AUSCAN Stiffness at 16 Weeks Change From Baseline
timeFrame: Baseline, 16 weeks
measure: AUSCAN Function Change at 4 Weeks From Baseline
timeFrame: Basline and 4 weeks
measure: AUSCAN Function Change at 8 Weeks From Baseline
timeFrame: Baseline and 8 weeks
measure: AUSCAN Function Change at 12 Weeks From Baseline
timeFrame: Baseline and 12 weeks
measure: AUSCAN Function Change at 16 Weeks From Baseline
timeFrame: Baseline and 16 weeks
measure: Patient Global Assessment, Change From Baseline
timeFrame: Baseline and 4 weeks
measure: Patient Global Assessment, Change From Baseline
timeFrame: Baseline and 8 weeks
measure: Patient Global Assessment, Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Patient Global Assessment, Change From Baseline
timeFrame: Baseline and 16 weeks
measure: Physician Global Assessment, Change From Baseline
timeFrame: baseline and 4 weeks
measure: Physician Global Assessment, Change From Baseline
timeFrame: Baseline and 8 weeks
measure: Physician Global Assessment, Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Physician Global Assessment, Change From Baseline
timeFrame: Baseline and 16 weeks
measure: Tender Joint Count, Change From Baseline
timeFrame: Baseline and 4 weeks
measure: Tender Joint Count, Change From Baseline
timeFrame: Baseline and 8 weeks
measure: Tender Joint Count, Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Tender Joint Count, Change From Baseline
timeFrame: Baseline and 16 weeks
measure: Swollen Joint Count, Change From Baseline
timeFrame: Baseline and 4 weeks
measure: Swollen Joint Count, Change From Baseline
timeFrame: Baseline and 8 weeks
measure: Swollen Joint Count, Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Swollen Joint Count, Change From Baseline
timeFrame: Baseline and 16 weeks
measure: Acetaminophen Rescue
timeFrame: Baseline 4 weeks
measure: Acetaminophen Rescue
timeFrame: 4 weeks and 8 weeks
measure: Acetaminophen Rescue
timeFrame: 8 weeks and 12 weeks
measure: Acetaminophen Rescue
timeFrame: 12 weeks and 16 weeks
measure: Number of OMERACT-OARSI Responder
timeFrame: Baseline and 4 weeks
measure: Number of OMERACT-OARSI Responder
timeFrame: Baseline and 8 weeks
measure: Number of OMERACT-OARSI Responder
timeFrame: Baseline and 12 weeks
measure: Number of OMERACT-OARSI Responder
timeFrame: Baselie and 16 weeks
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul National University College of Medicine
name: Eun Bong Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Jin Kyun Park, MD
role: STUDY_DIRECTOR
affiliation: Seoul National Universty Bundang Hospital
name: Yun Jong Lee, MD PhD
role: STUDY_DIRECTOR
affiliation: SMG-SNU Boramae Medical Center
name: Kichul Shin, MD PhD
role: STUDY_DIRECTOR
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citation: Park JK, Shin K, Kang EH, Ha YJ, Lee YJ, Lee KH, Lee EY, Song YW, Choi Y, Lee EB. Efficacy and Tolerability of GCSB-5 for Hand Osteoarthritis: A Randomized, Controlled Trial. Clin Ther. 2016 Aug;38(8):1858-1868.e2. doi: 10.1016/j.clinthera.2016.06.016. Epub 2016 Jul 21.