Trial Outcomes & Findings for Efficacy of Shinabro in Hand Osteoarthritis (NCT NCT01910116)

NCT ID: NCT01910116

Last Updated: 2015-12-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 220 participants
• Primary outcome timeframe: Baseline and 4 weeks
• Results posted on: 2015-12-17

Participant Flow

Participant milestones

Measure	Shinbaro Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks Shinbaro	Placebo Placebo 2 capsules, twice daily, for 12 weeks. Placebo
Overall Study STARTED	110	110
Overall Study Week 4	106	102
Overall Study Week 8	98	99
Overall Study Week 12	97	96
Overall Study Week 16	96	94
Overall Study COMPLETED	96	94
Overall Study NOT COMPLETED	14	16

Reasons for withdrawal

Measure	Shinbaro Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks Shinbaro	Placebo Placebo 2 capsules, twice daily, for 12 weeks. Placebo
Overall Study Adverse Event	0	3
Overall Study Lack of Efficacy	3	4
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	2
Overall Study Withdrawal by Subject	8	3
Overall Study uncertain allocation	1	3
Overall Study incomplete data	0	1

Baseline Characteristics

Efficacy of Shinabro in Hand Osteoarthritis

Baseline characteristics by cohort

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks	Total n=215 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 7.2 • n=93 Participants	59.4 years STANDARD_DEVIATION 8.0 • n=4 Participants	60.1 years STANDARD_DEVIATION 7.6 • n=27 Participants
Sex: Female, Male Female	100 Participants n=93 Participants	98 Participants n=4 Participants	198 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Weight	58.9 kg STANDARD_DEVIATION 7.4 • n=93 Participants	59.0 kg STANDARD_DEVIATION 8.1 • n=4 Participants	58.9 kg STANDARD_DEVIATION 7.7 • n=27 Participants
Height	156.7 cm STANDARD_DEVIATION 6.7 • n=93 Participants	157.0 cm STANDARD_DEVIATION 6.0 • n=4 Participants	156.8 cm STANDARD_DEVIATION 6.3 • n=27 Participants
Body mass index	23.9 kg/m2 STANDARD_DEVIATION 2.5 • n=93 Participants	23.9 kg/m2 STANDARD_DEVIATION 2.8 • n=4 Participants	23.9 kg/m2 STANDARD_DEVIATION 2.6 • n=27 Participants
Duration of OA	28.6 months STANDARD_DEVIATION 46.8 • n=93 Participants	31.7 months STANDARD_DEVIATION 47.2 • n=4 Participants	30.1 months STANDARD_DEVIATION 46.9 • n=27 Participants
Family history of OA Yes	30 participants n=93 Participants	25 participants n=4 Participants	55 participants n=27 Participants
Family history of OA No	79 participants n=93 Participants	81 participants n=4 Participants	160 participants n=27 Participants
AUSCAN pain (0-100)	49.7 units on a scale STANDARD_DEVIATION 16.7 • n=93 Participants	48.2 units on a scale STANDARD_DEVIATION 19.9 • n=4 Participants	48.9 units on a scale STANDARD_DEVIATION 18.3 • n=27 Participants
AUSCAN stiffness score (0-100)	55.2 units on a scale STANDARD_DEVIATION 23.8 • n=93 Participants	60.4 units on a scale STANDARD_DEVIATION 22.8 • n=4 Participants	57.8 units on a scale STANDARD_DEVIATION 23.4 • n=27 Participants
AUSCAN function score (0-100)	47.2 units on a scale STANDARD_DEVIATION 21.8 • n=93 Participants	46.2 units on a scale STANDARD_DEVIATION 23.9 • n=4 Participants	46.6 units on a scale STANDARD_DEVIATION 22.9 • n=27 Participants
Tender joint count	7.7 Joint STANDARD_DEVIATION 5.2 • n=93 Participants	6.5 Joint STANDARD_DEVIATION 5.2 • n=4 Participants	7.1 Joint STANDARD_DEVIATION 5.1 • n=27 Participants
Swollen joint count	0.6 Joint STANDARD_DEVIATION 1.8 • n=93 Participants	0.9 Joint STANDARD_DEVIATION 2.4 • n=4 Participants	0.8 Joint STANDARD_DEVIATION 2.1 • n=27 Participants
Patient global assessment (1-100)	49.6 units on a scale STANDARD_DEVIATION 16.5 • n=93 Participants	50.1 units on a scale STANDARD_DEVIATION 16.3 • n=4 Participants	49.9 units on a scale STANDARD_DEVIATION 16.3 • n=27 Participants
Physician global assessment (1-100)	43.1 units on a scale STANDARD_DEVIATION 11.1 • n=93 Participants	41.5 units on a scale STANDARD_DEVIATION 13.0 • n=4 Participants	42.3 units on a scale STANDARD_DEVIATION 12.1 • n=27 Participants
Erythrocyte sedimentation rate (ESR)	14.2 mm/hr STANDARD_DEVIATION 14.6 • n=93 Participants	13.3 mm/hr STANDARD_DEVIATION 10.0 • n=4 Participants	13.8 mm/hr STANDARD_DEVIATION 12.5 • n=27 Participants
C-reactive protein (CRP)	0.09 mg/dL STANDARD_DEVIATION 0.11 • n=93 Participants	0.12 mg/dL STANDARD_DEVIATION 0.26 • n=4 Participants	0.10 mg/dL STANDARD_DEVIATION 0.20 • n=27 Participants
Acetaminophen yes	9 participants n=93 Participants	10 participants n=4 Participants	19 participants n=27 Participants
Acetaminophen no	100 participants n=93 Participants	96 participants n=4 Participants	196 participants n=27 Participants
Tramadol Yes	8 participants n=93 Participants	11 participants n=4 Participants	19 participants n=27 Participants
Tramadol no	101 participants n=93 Participants	95 participants n=4 Participants	196 participants n=27 Participants
NSAIDs yes	36 participants n=93 Participants	36 participants n=4 Participants	72 participants n=27 Participants
NSAIDs no	73 participants n=93 Participants	70 participants n=4 Participants	143 participants n=27 Participants
Glucosamine yes	14 participants n=93 Participants	13 participants n=4 Participants	27 participants n=27 Participants
Glucosamine no	95 participants n=93 Participants	93 participants n=4 Participants	188 participants n=27 Participants
Diacerin yes	5 participants n=93 Participants	3 participants n=4 Participants	8 participants n=27 Participants
Diacerin no	104 participants n=93 Participants	103 participants n=4 Participants	207 participants n=27 Participants
Others yes	1 participants n=93 Participants	3 participants n=4 Participants	4 participants n=27 Participants
Others no	108 participants n=93 Participants	103 participants n=4 Participants	211 participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Pain Change at 4 Weeks From Baseline	-9.0 units on a scale Interval -23.6 to -0.4	-2.2 units on a scale Interval -16.6 to 6.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Pain Score at 8 Weeks From Baseline	-13.4 units on a scale Interval -26.2 to 0.0	-2.2 units on a scale Interval -17.4 to 4.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Pain Score at 12 Weeks From Baseline	-14.6 units on a scale Interval -30.4 to 0.0	-8.0 units on a scale Interval -25.0 to 7.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Pain Score at 16 Weeks From Baseline	-15.6 units on a scale Interval -28.2 to 0.0	-4.4 units on a scale Interval -24.8 to 7.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Stiffness at 4 Weeks Change From Baseline	-9.0 units on a scale Interval -22.0 to 3.0	-6.0 units on a scale Interval -23.0 to 6.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Stiffness at 8 Weeks Change From Baseline	-12.0 units on a scale Interval -28.0 to 2.0	-6 units on a scale Interval -27.0 to 4.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Stiffness at 12 Weeks Change From Baseline	-14.0 units on a scale Interval -36.0 to 0.0	-11.0 units on a scale Interval -29.8 to 5.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Stiffness at 16 Weeks Change From Baseline	-10.0 units on a scale Interval -27.0 to 2.0	-8.0 units on a scale Interval -27.0 to 5.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Function Change at 4 Weeks From Baseline	-6.8 units on a scale Interval -18.9 to 3.6	-3.7 units on a scale Interval -13.7 to 6.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Function Change at 8 Weeks From Baseline	-9.7 units on a scale Interval -26.9 to 2.6	-4.8 units on a scale Interval -18.6 to 7.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Function Change at 12 Weeks From Baseline	-11 units on a scale Interval -27.8 to 0.8	-2.9 units on a scale Interval -18.7 to 9.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
AUSCAN Function Change at 16 Weeks From Baseline	-9.9 units on a scale Interval -28.7 to 1.8	-4.8 units on a scale Interval -18.7 to 9.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Patient Global Assessment, Change From Baseline	-9.0 units on a scale Interval -24.0 to 2.0	-3.0 units on a scale Interval -15.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Patient Global Assessment, Change From Baseline	-10.0 units on a scale Interval -24.5 to 0.0	-6.0 units on a scale Interval -18.0 to 12.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Patient Global Assessment, Change From Baseline	-11.0 units on a scale Interval -30.0 to 1.0	-6.0 units on a scale Interval -24.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and 16 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Patient Global Assessment, Change From Baseline	-10.0 units on a scale Interval -29.0 to 3.0	-8.5 units on a scale Interval -21.0 to 9.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Physician Global Assessment, Change From Baseline	-12 units on a scale Interval -21.0 to 0.0	-7.0 units on a scale Interval -19.0 to 1.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Physician Global Assessment, Change From Baseline	-16.0 units on a scale Interval -26.0 to -4.0	-11.5 units on a scale Interval -25.3 to 0.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Physician Global Assessment, Change From Baseline	-19.0 units on a scale Interval -29.0 to -5.0	-13 units on a scale Interval -27.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 16 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Physician Global Assessment, Change From Baseline	-12 units on a scale Interval -23.5 to 0.0	-6.5 units on a scale Interval -20.0 to 1.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Tender Joint Count, Change From Baseline	-1 joints Interval -4.0 to 0.0	0 joints Interval -3.0 to 1.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Tender Joint Count, Change From Baseline	-1.0 Joints Interval -4.0 to 0.0	-1.0 Joints Interval -5.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Tender Joint Count, Change From Baseline	-2.0 joints Interval -5.0 to 0.0	-1.0 joints Interval -4.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 16 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Tender Joint Count, Change From Baseline	-2.0 joints Interval -5.0 to 1.0	-1.0 joints Interval -5.0 to 1.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Swollen Joint Count, Change From Baseline	0 Joints Interval 0.0 to 0.0	0 Joints Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Swollen Joint Count, Change From Baseline	0 Joints Interval 0.0 to 0.0	0 Joints Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Swollen Joint Count, Change From Baseline	0 Joints Interval 0.0 to 0.0	0 Joints Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 16 weeks

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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Swollen Joint Count, Change From Baseline	0 Joints Interval 0.0 to 0.0	0 Joints Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline 4 weeks

yes = AAP rescue use, no = no AAP rescue use

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Acetaminophen Rescue yes	7 participants	4 participants
Acetaminophen Rescue no	102 participants	102 participants

SECONDARY outcome

Timeframe: 4 weeks and 8 weeks

yes = AAP rescue use, no = no AAP rescue use

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Acetaminophen Rescue yes	10 participants	7 participants
Acetaminophen Rescue no	99 participants	99 participants

SECONDARY outcome

Timeframe: 8 weeks and 12 weeks

yes = AAP rescue use, no = no AAP rescue use

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Acetaminophen Rescue yes	4 participants	4 participants
Acetaminophen Rescue no	105 participants	102 participants

SECONDARY outcome

Timeframe: 12 weeks and 16 weeks

yes = AAP rescue use, no = no AAP rescue use

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Acetaminophen Rescue yes	4 participants	2 participants
Acetaminophen Rescue no	105 participants	104 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Number of OMERACT-OARSI Responder Responder	48 participants	32 participants
Number of OMERACT-OARSI Responder Nonresponder	61 participants	74 participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Number of OMERACT-OARSI Responder responder	56 participants	38 participants
Number of OMERACT-OARSI Responder nonresponder	53 participants	68 participants

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Number of OMERACT-OARSI Responder responder	62 participants	43 participants
Number of OMERACT-OARSI Responder nonresponder	47 participants	63 participants

SECONDARY outcome

Timeframe: Baselie and 16 weeks

Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Outcome measures

Measure	Shinbaro n=109 Participants Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 Participants Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Number of OMERACT-OARSI Responder	55 participants	40 participants

Adverse Events

Shinbaro

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	Shinbaro n=109 participants at risk GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 participants at risk Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)
General disorders Surgery	0.92% 1/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)
Musculoskeletal and connective tissue disorders Skin rash	0.00% 0/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)
Hepatobiliary disorders liver function abnormality	0.00% 0/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)

Other adverse events

Measure	Shinbaro n=109 participants at risk GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks	Placebo n=106 participants at risk Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks
Nervous system disorders Headache	3.7% 4/109 • Any event between randomization (week 0) and study end (week 16)	2.8% 3/106 • Any event between randomization (week 0) and study end (week 16)
Nervous system disorders Dizziness	0.92% 1/109 • Any event between randomization (week 0) and study end (week 16)	1.9% 2/106 • Any event between randomization (week 0) and study end (week 16)
Nervous system disorders Paresthesia	1.8% 2/109 • Any event between randomization (week 0) and study end (week 16)	3.8% 4/106 • Any event between randomization (week 0) and study end (week 16)
Skin and subcutaneous tissue disorders Skin rash	9.2% 10/109 • Any event between randomization (week 0) and study end (week 16)	11.3% 12/106 • Any event between randomization (week 0) and study end (week 16)
Gastrointestinal disorders Nausea	8.3% 9/109 • Any event between randomization (week 0) and study end (week 16)	9.4% 10/106 • Any event between randomization (week 0) and study end (week 16)
Gastrointestinal disorders Abdominal discomfort	16.5% 18/109 • Any event between randomization (week 0) and study end (week 16)	12.3% 13/106 • Any event between randomization (week 0) and study end (week 16)
Gastrointestinal disorders Diarrhea	0.92% 1/109 • Any event between randomization (week 0) and study end (week 16)	1.9% 2/106 • Any event between randomization (week 0) and study end (week 16)
Hepatobiliary disorders Liver function change	7.3% 8/109 • Any event between randomization (week 0) and study end (week 16)	7.5% 8/106 • Any event between randomization (week 0) and study end (week 16)
Blood and lymphatic system disorders Leukopenia	10.1% 11/109 • Any event between randomization (week 0) and study end (week 16)	7.5% 8/106 • Any event between randomization (week 0) and study end (week 16)
Blood and lymphatic system disorders Anemia	1.8% 2/109 • Any event between randomization (week 0) and study end (week 16)	3.8% 4/106 • Any event between randomization (week 0) and study end (week 16)
Immune system disorders Upper respiratory infection	14.7% 16/109 • Any event between randomization (week 0) and study end (week 16)	4.7% 5/106 • Any event between randomization (week 0) and study end (week 16)
Immune system disorders Zoster	0.00% 0/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)
Eye disorders Visual floater	0.92% 1/109 • Any event between randomization (week 0) and study end (week 16)	0.00% 0/106 • Any event between randomization (week 0) and study end (week 16)
Psychiatric disorders Depressive mood	0.00% 0/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)
Psychiatric disorders insomnia	0.00% 0/109 • Any event between randomization (week 0) and study end (week 16)	2.8% 3/106 • Any event between randomization (week 0) and study end (week 16)
Surgical and medical procedures Surgery	0.92% 1/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/109 • Any event between randomization (week 0) and study end (week 16)	0.94% 1/106 • Any event between randomization (week 0) and study end (week 16)

Additional Information

Prof. Eun Bong Lee

Seoul National University Hospital

Phone: 822-2072-3944

Email: leb7616@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place