Efficacy of Shinabro in Hand Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.

Conditions
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Hand Osteoarthritis

Intervention / Treatment
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* Drug: Shinbaro
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo 2 capsules, twice daily, for 12 weeks. | Drug: Placebo<br>* The study medication and placebo were identical in appearance.<br>|
| Active Comparator: Shinbaro<br>Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks | Drug: Shinbaro<br>* GCSB-5 (Shinbaro) is a mixture of six purified oriental herb extracts in a fixed ratio, namely, Saposhnikovia divaricata Schischk, Glycine max Merrill, Cibotium barometz J. Smith, Eucommia ulmoides Oliver, Achyranthes japonica Nakai, and Acanthopanax sessiliflorus Seem<br>* Other names: GCSB-5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUSCAN Pain Change at 4 Weeks From Baseline | Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUSCAN Pain Score at 8 Weeks From Baseline | Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline, 8 weeks | 
| AUSCAN Pain Score at 12 Weeks From Baseline | Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline, 12 weeks | 
| AUSCAN Pain Score at 16 Weeks From Baseline | Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 16 weeks | 
| AUSCAN Stiffness at 4 Weeks Change From Baseline | Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 4 weeks | 
| AUSCAN Stiffness at 8 Weeks Change From Baseline | Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). Negative value means improvement from baseline Positive value means deterioration from baseline | baseline and 8 weeks | 
| AUSCAN Stiffness at 12 Weeks Change From Baseline | Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). Negative value means improvement from baseline Positive value means deterioration from baseline | Basline and 12 weeks | 
| AUSCAN Stiffness at 16 Weeks Change From Baseline | Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline, 16 weeks | 
| AUSCAN Function Change at 4 Weeks From Baseline | Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). Negative value means improvement from baseline Positive value means deterioration from baseline | Basline and 4 weeks | 
| AUSCAN Function Change at 8 Weeks From Baseline | Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 8 weeks | 
| AUSCAN Function Change at 12 Weeks From Baseline | Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 12 weeks | 
| AUSCAN Function Change at 16 Weeks From Baseline | Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 16 weeks | 
| Patient Global Assessment, Change From Baseline | Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 4 weeks | 
| Patient Global Assessment, Change From Baseline | Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 8 weeks | 
| Patient Global Assessment, Change From Baseline | Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 12 weeks | 
| Patient Global Assessment, Change From Baseline | Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 16 weeks | 
| Physician Global Assessment, Change From Baseline | Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | baseline and 4 weeks | 
| Physician Global Assessment, Change From Baseline | Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 8 weeks | 
| Physician Global Assessment, Change From Baseline | Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 12 weeks | 
| Physician Global Assessment, Change From Baseline | Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 16 weeks | 
| Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 4 weeks | 
| Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 8 weeks | 
| Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 12 weeks | 
| Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 16 weeks | 
| Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 4 weeks | 
| Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 8 weeks | 
| Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 12 weeks | 
| Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline.. Negative value means improvement from baseline Positive value means deterioration from baseline | Baseline and 16 weeks | 
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | Baseline 4 weeks | 
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | 4 weeks and 8 weeks | 
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | 8 weeks and 12 weeks | 
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | 12 weeks and 16 weeks | 
| Number of OMERACT-OARSI Responder | Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment | Baseline and 4 weeks | 
| Number of OMERACT-OARSI Responder | Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment | Baseline and 8 weeks | 
| Number of OMERACT-OARSI Responder | Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment | Baseline and 12 weeks | 
| Number of OMERACT-OARSI Responder | Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment | Baselie and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, hand, Shinbaro, GCSB-5