Hand Osteoarthritis
Conditions
Keywords
osteoarthritis, hand, Shinbaro, GCSB-5
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.
Interventions
DRUGShinbaro
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
DRUGPlacebo
The study medication and placebo were identical in appearance.
Sponsors
Green Cross Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUSCAN Pain Change at 4 Weeks From Baseline | Baseline and 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUSCAN Pain Score at 12 Weeks From Baseline | Baseline, 12 weeks | 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 |
| AUSCAN Pain Score at 16 Weeks From Baseline | Baseline and 16 weeks | 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 |
| AUSCAN Stiffness at 4 Weeks Change From Baseline | Baseline and 4 weeks | 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 |
| AUSCAN Stiffness at 8 Weeks Change From Baseline | baseline and 8 weeks | 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 |
| AUSCAN Stiffness at 12 Weeks Change From Baseline | Basline and 12 weeks | 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 |
| AUSCAN Stiffness at 16 Weeks Change From Baseline | Baseline, 16 weeks | 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 |
| AUSCAN Function Change at 4 Weeks From Baseline | Basline and 4 weeks | 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 |
| AUSCAN Function Change at 8 Weeks From Baseline | Baseline and 8 weeks | 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 |
| AUSCAN Pain Score at 8 Weeks From Baseline | Baseline, 8 weeks | 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 |
| AUSCAN Function Change at 16 Weeks From Baseline | Baseline and 16 weeks | 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 |
| Patient Global Assessment, Change From Baseline | Baseline and 4 weeks | 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 |
| Physician Global Assessment, Change From Baseline | baseline and 4 weeks | 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 |
| Tender Joint Count, Change From Baseline | Baseline and 4 weeks | 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 |
| Swollen Joint Count, Change From Baseline | Baseline and 4 weeks | 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 |
| Acetaminophen Rescue | Baseline 4 weeks | yes = AAP rescue use, no = no AAP rescue use |
| Number of OMERACT-OARSI Responder | Baseline and 4 weeks | 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 |
| AUSCAN Function Change at 12 Weeks From Baseline | Baseline and 12 weeks | 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shinbaro Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks | 109 |
| Placebo Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks | 106 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | incomplete data | 0 | 1 |
| Overall Study | Lack of Efficacy | 3 | 4 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | uncertain allocation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | Shinbaro | Placebo | Total |
|---|---|---|---|
| Acetaminophen no | 100 participants | 96 participants | 196 participants |
| Acetaminophen yes | 9 participants | 10 participants | 19 participants |
| Age, Continuous | 60.7 years STANDARD_DEVIATION 7.2 | 59.4 years STANDARD_DEVIATION 8 | 60.1 years STANDARD_DEVIATION 7.6 |
| AUSCAN function score (0-100) | 47.2 units on a scale STANDARD_DEVIATION 21.8 | 46.2 units on a scale STANDARD_DEVIATION 23.9 | 46.6 units on a scale STANDARD_DEVIATION 22.9 |
| AUSCAN pain (0-100) | 49.7 units on a scale STANDARD_DEVIATION 16.7 | 48.2 units on a scale STANDARD_DEVIATION 19.9 | 48.9 units on a scale STANDARD_DEVIATION 18.3 |
| AUSCAN stiffness score (0-100) | 55.2 units on a scale STANDARD_DEVIATION 23.8 | 60.4 units on a scale STANDARD_DEVIATION 22.8 | 57.8 units on a scale STANDARD_DEVIATION 23.4 |
| Body mass index | 23.9 kg/m2 STANDARD_DEVIATION 2.5 | 23.9 kg/m2 STANDARD_DEVIATION 2.8 | 23.9 kg/m2 STANDARD_DEVIATION 2.6 |
| C-reactive protein (CRP) | 0.09 mg/dL STANDARD_DEVIATION 0.11 | 0.12 mg/dL STANDARD_DEVIATION 0.26 | 0.10 mg/dL STANDARD_DEVIATION 0.2 |
| Diacerin no | 104 participants | 103 participants | 207 participants |
| Diacerin yes | 5 participants | 3 participants | 8 participants |
| Duration of OA | 28.6 months STANDARD_DEVIATION 46.8 | 31.7 months STANDARD_DEVIATION 47.2 | 30.1 months STANDARD_DEVIATION 46.9 |
| Erythrocyte sedimentation rate (ESR) | 14.2 mm/hr STANDARD_DEVIATION 14.6 | 13.3 mm/hr STANDARD_DEVIATION 10 | 13.8 mm/hr STANDARD_DEVIATION 12.5 |
| Family history of OA No | 79 participants | 81 participants | 160 participants |
| Family history of OA Yes | 30 participants | 25 participants | 55 participants |
| Glucosamine no | 95 participants | 93 participants | 188 participants |
| Glucosamine yes | 14 participants | 13 participants | 27 participants |
| Height | 156.7 cm STANDARD_DEVIATION 6.7 | 157.0 cm STANDARD_DEVIATION 6 | 156.8 cm STANDARD_DEVIATION 6.3 |
| NSAIDs no | 73 participants | 70 participants | 143 participants |
| NSAIDs yes | 36 participants | 36 participants | 72 participants |
| Others no | 108 participants | 103 participants | 211 participants |
| Others yes | 1 participants | 3 participants | 4 participants |
| Patient global assessment (1-100) | 49.6 units on a scale STANDARD_DEVIATION 16.5 | 50.1 units on a scale STANDARD_DEVIATION 16.3 | 49.9 units on a scale STANDARD_DEVIATION 16.3 |
| Physician global assessment (1-100) | 43.1 units on a scale STANDARD_DEVIATION 11.1 | 41.5 units on a scale STANDARD_DEVIATION 13 | 42.3 units on a scale STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 100 Participants | 98 Participants | 198 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
| Swollen joint count | 0.6 Joint STANDARD_DEVIATION 1.8 | 0.9 Joint STANDARD_DEVIATION 2.4 | 0.8 Joint STANDARD_DEVIATION 2.1 |
| Tender joint count | 7.7 Joint STANDARD_DEVIATION 5.2 | 6.5 Joint STANDARD_DEVIATION 5.2 | 7.1 Joint STANDARD_DEVIATION 5.1 |
| Tramadol no | 101 participants | 95 participants | 196 participants |
| Tramadol Yes | 8 participants | 11 participants | 19 participants |
| Weight | 58.9 kg STANDARD_DEVIATION 7.4 | 59.0 kg STANDARD_DEVIATION 8.1 | 58.9 kg STANDARD_DEVIATION 7.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 55 / 109 | 45 / 106 |
| serious Total, serious adverse events | 1 / 109 | 4 / 106 |
Outcome results
Primary
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
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Pain Change at 4 Weeks From Baseline | -9.0 units on a scale |
| Placebo | AUSCAN Pain Change at 4 Weeks From Baseline | -2.2 units on a scale |
Comparison: Assuming that an improvement in AUSCAN pain score of \>10 is clinically meaningful, and assuming an alpha level of 0.05 (two-tailed), a power of 0.80, and a dropout rate of 20%, the sample size calculation revealed that 220 patients should be enrolled.p-value: 0.014Wilcoxon (Mann-Whitney)
Secondary
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: Baseline 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shinbaro | Acetaminophen Rescue | yes | 7 participants |
| Shinbaro | Acetaminophen Rescue | no | 102 participants |
| Placebo | Acetaminophen Rescue | yes | 4 participants |
| Placebo | Acetaminophen Rescue | no | 102 participants |
p-value: 0.378Chi-squared
Secondary
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: 12 weeks and 16 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shinbaro | Acetaminophen Rescue | yes | 4 participants |
| Shinbaro | Acetaminophen Rescue | no | 105 participants |
| Placebo | Acetaminophen Rescue | yes | 2 participants |
| Placebo | Acetaminophen Rescue | no | 104 participants |
p-value: 0.683Fisher Exact
Secondary
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: 8 weeks and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shinbaro | Acetaminophen Rescue | yes | 4 participants |
| Shinbaro | Acetaminophen Rescue | no | 105 participants |
| Placebo | Acetaminophen Rescue | no | 102 participants |
| Placebo | Acetaminophen Rescue | yes | 4 participants |
p-value: 1Fisher Exact
Secondary
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Time frame: 4 weeks and 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shinbaro | Acetaminophen Rescue | yes | 10 participants |
| Shinbaro | Acetaminophen Rescue | no | 99 participants |
| Placebo | Acetaminophen Rescue | yes | 7 participants |
| Placebo | Acetaminophen Rescue | no | 99 participants |
p-value: 0.485Chi-squared
Secondary
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
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Function Change at 12 Weeks From Baseline | -11 units on a scale |
| Placebo | AUSCAN Function Change at 12 Weeks From Baseline | -2.9 units on a scale |
Secondary
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
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Function Change at 16 Weeks From Baseline | -9.9 units on a scale |
| Placebo | AUSCAN Function Change at 16 Weeks From Baseline | -4.8 units on a scale |
p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Basline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Function Change at 4 Weeks From Baseline | -6.8 units on a scale |
| Placebo | AUSCAN Function Change at 4 Weeks From Baseline | -3.7 units on a scale |
p-value: 0.122Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Function Change at 8 Weeks From Baseline | -9.7 units on a scale |
| Placebo | AUSCAN Function Change at 8 Weeks From Baseline | -4.8 units on a scale |
p-value: 0.097Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Pain Score at 12 Weeks From Baseline | -14.6 units on a scale |
| Placebo | AUSCAN Pain Score at 12 Weeks From Baseline | -8.0 units on a scale |
p-value: 0.053Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Pain Score at 16 Weeks From Baseline | -15.6 units on a scale |
| Placebo | AUSCAN Pain Score at 16 Weeks From Baseline | -4.4 units on a scale |
p-value: 0.014Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Pain Score at 8 Weeks From Baseline | -13.4 units on a scale |
| Placebo | AUSCAN Pain Score at 8 Weeks From Baseline | -2.2 units on a scale |
p-value: 0.011Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Basline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Stiffness at 12 Weeks Change From Baseline | -14.0 units on a scale |
| Placebo | AUSCAN Stiffness at 12 Weeks Change From Baseline | -11.0 units on a scale |
p-value: 0.194Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline, 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Stiffness at 16 Weeks Change From Baseline | -10.0 units on a scale |
| Placebo | AUSCAN Stiffness at 16 Weeks Change From Baseline | -8.0 units on a scale |
p-value: 0.347Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Stiffness at 4 Weeks Change From Baseline | -9.0 units on a scale |
| Placebo | AUSCAN Stiffness at 4 Weeks Change From Baseline | -6.0 units on a scale |
p-value: 0.728Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | AUSCAN Stiffness at 8 Weeks Change From Baseline | -12.0 units on a scale |
| Placebo | AUSCAN Stiffness at 8 Weeks Change From Baseline | -6 units on a scale |
p-value: 0.229Wilcoxon (Mann-Whitney)
Secondary
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Time frame: Baselie and 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shinbaro | Number of OMERACT-OARSI Responder | 55 participants |
| Placebo | Number of OMERACT-OARSI Responder | 40 participants |
p-value: 0.06Chi-squared
Secondary
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
Time frame: Baseline and 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shinbaro | Number of OMERACT-OARSI Responder | Responder | 48 participants |
| Shinbaro | Number of OMERACT-OARSI Responder | Nonresponder | 61 participants |
| Placebo | Number of OMERACT-OARSI Responder | Responder | 32 participants |
| Placebo | Number of OMERACT-OARSI Responder | Nonresponder | 74 participants |
p-value: 0.036Chi-squared
Secondary
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shinbaro | Number of OMERACT-OARSI Responder | responder | 56 participants |
| Shinbaro | Number of OMERACT-OARSI Responder | nonresponder | 53 participants |
| Placebo | Number of OMERACT-OARSI Responder | responder | 38 participants |
| Placebo | Number of OMERACT-OARSI Responder | nonresponder | 68 participants |
p-value: 0.022Chi-squared
Secondary
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shinbaro | Number of OMERACT-OARSI Responder | responder | 62 participants |
| Shinbaro | Number of OMERACT-OARSI Responder | nonresponder | 47 participants |
| Placebo | Number of OMERACT-OARSI Responder | responder | 43 participants |
| Placebo | Number of OMERACT-OARSI Responder | nonresponder | 63 participants |
p-value: 0.017Chi-squared
Secondary
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
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Patient Global Assessment, Change From Baseline | -10.0 units on a scale |
| Placebo | Patient Global Assessment, Change From Baseline | -8.5 units on a scale |
p-value: 0.221Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Patient Global Assessment, Change From Baseline | -9.0 units on a scale |
| Placebo | Patient Global Assessment, Change From Baseline | -3.0 units on a scale |
p-value: 0.031Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Patient Global Assessment, Change From Baseline | -10.0 units on a scale |
| Placebo | Patient Global Assessment, Change From Baseline | -6.0 units on a scale |
p-value: 0.021Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Patient Global Assessment, Change From Baseline | -11.0 units on a scale |
| Placebo | Patient Global Assessment, Change From Baseline | -6.0 units on a scale |
p-value: 0.049Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Physician Global Assessment, Change From Baseline | -12 units on a scale |
| Placebo | Physician Global Assessment, Change From Baseline | -6.5 units on a scale |
p-value: 0.126Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Physician Global Assessment, Change From Baseline | -12 units on a scale |
| Placebo | Physician Global Assessment, Change From Baseline | -7.0 units on a scale |
p-value: 0.174Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Physician Global Assessment, Change From Baseline | -16.0 units on a scale |
| Placebo | Physician Global Assessment, Change From Baseline | -11.5 units on a scale |
p-value: 0.124Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Physician Global Assessment, Change From Baseline | -19.0 units on a scale |
| Placebo | Physician Global Assessment, Change From Baseline | -13 units on a scale |
p-value: 0.128Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Swollen Joint Count, Change From Baseline | 0 Joints |
| Placebo | Swollen Joint Count, Change From Baseline | 0 Joints |
p-value: 0.493Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Swollen Joint Count, Change From Baseline | 0 Joints |
| Placebo | Swollen Joint Count, Change From Baseline | 0 Joints |
p-value: 0.062Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Swollen Joint Count, Change From Baseline | 0 Joints |
| Placebo | Swollen Joint Count, Change From Baseline | 0 Joints |
p-value: 0.604Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Swollen Joint Count, Change From Baseline | 0 Joints |
| Placebo | Swollen Joint Count, Change From Baseline | 0 Joints |
p-value: 0.252Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Tender Joint Count, Change From Baseline | -1.0 Joints |
| Placebo | Tender Joint Count, Change From Baseline | -1.0 Joints |
p-value: 0.66Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Tender Joint Count, Change From Baseline | -2.0 joints |
| Placebo | Tender Joint Count, Change From Baseline | -1.0 joints |
p-value: 0.186Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Tender Joint Count, Change From Baseline | -2.0 joints |
| Placebo | Tender Joint Count, Change From Baseline | -1.0 joints |
p-value: 0.006Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Shinbaro | Tender Joint Count, Change From Baseline | -1 joints |
| Placebo | Tender Joint Count, Change From Baseline | 0 joints |
p-value: 0.042Wilcoxon (Mann-Whitney)