Efficacy of Shinabro in Hand Osteoarthritis

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赞助商

Seoul National University Hospital

合作者

Green Cross Corporation

临床试验: NCT01910116

BioSeek: nct01910116

关键词

抽象

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.

描述

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.

日期

最后验证:	07/31/2015
首次提交:	07/21/2013
提交的预估入学人数:	07/25/2013
首次发布:	07/28/2013
上次提交的更新:	11/15/2015
最近更新发布:	12/16/2015
首次提交结果的日期:	02/27/2015
首次提交质量检查结果的日期:	11/15/2015
首次发布结果的日期:	12/16/2015
实际学习开始日期:	08/31/2013
预计主要完成日期:	10/31/2014
预计完成日期:	10/31/2014

状况或疾病

Hand Osteoarthritis

干预/治疗

Drug: Shinbaro

Drug: Placebo

相

相 2/相 3

手臂组

臂	干预/治疗
Placebo Comparator: Placebo Placebo 2 capsules, twice daily, for 12 weeks.	Drug: Placebo The study medication and placebo were identical in appearance.
Active Comparator: Shinbaro Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks	Drug: Shinbaro 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

资格标准

有资格学习的年龄	18 Years 至 18 Years
有资格学习的性别	All
接受健康志愿者	是
标准	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

结果

主要结果指标

1. 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

次要成果指标

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Patient Global Assessment, Change From Baseline [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

14. Patient Global Assessment, Change From Baseline [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

15. Patient Global Assessment, Change From Baseline [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

16. 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

17. Physician Global Assessment, Change From Baseline [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

18. Physician Global Assessment, Change From Baseline [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

19. Physician Global Assessment, Change From Baseline [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

20. 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

21. Tender Joint Count, Change From Baseline [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

22. Tender Joint Count, Change From Baseline [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

23. Tender Joint Count, Change From Baseline [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

24. 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

25. Swollen Joint Count, Change From Baseline [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

26. Swollen Joint Count, Change From Baseline [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

27. Swollen Joint Count, Change From Baseline [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

28. Acetaminophen Rescue [Baseline 4 weeks]

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

29. Acetaminophen Rescue [4 weeks and 8 weeks]

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

30. Acetaminophen Rescue [8 weeks and 12 weeks]

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

31. Acetaminophen Rescue [12 weeks and 16 weeks]

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

32. 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

33. Number of OMERACT-OARSI Responder [Baseline and 8 weeks]

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

34. Number of OMERACT-OARSI Responder [Baseline and 12 weeks]

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

35. Number of OMERACT-OARSI Responder [Baselie and 16 weeks]

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

Efficacy of Shinabro in Hand Osteoarthritis

关键词

hemorrhage

inflammation

ulcer

gastritis

stomach ulcer

osteoarthritis

消炎（药

止痛药

抽象

描述

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

科学支持的最完整的草药数据库