Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- AUSCAN Pain Change at 4 Weeks From Baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo 2 capsules, twice daily, for 12 weeks.
干预措施: Placebo (Drug)
Shinbaro
Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
干预措施: Shinbaro (Drug)
结局指标
主要结局
AUSCAN Pain Change at 4 Weeks From Baseline
时间窗: 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
次要结局
- AUSCAN Pain Score at 8 Weeks From Baseline(Baseline, 8 weeks)
- AUSCAN Function Change at 12 Weeks From Baseline(Baseline and 12 weeks)
- Acetaminophen Rescue(12 weeks and 16 weeks)
- AUSCAN Pain Score at 12 Weeks From Baseline(Baseline, 12 weeks)
- AUSCAN Stiffness at 4 Weeks Change From Baseline(Baseline and 4 weeks)
- AUSCAN Stiffness at 8 Weeks Change From Baseline(baseline and 8 weeks)
- AUSCAN Stiffness at 12 Weeks Change From Baseline(Basline and 12 weeks)
- AUSCAN Function Change at 4 Weeks From Baseline(Basline and 4 weeks)
- AUSCAN Function Change at 16 Weeks From Baseline(Baseline and 16 weeks)
- Number of OMERACT-OARSI Responder(Baselie and 16 weeks)
- AUSCAN Pain Score at 16 Weeks From Baseline(Baseline and 16 weeks)
- AUSCAN Stiffness at 16 Weeks Change From Baseline(Baseline, 16 weeks)
- AUSCAN Function Change at 8 Weeks From Baseline(Baseline and 8 weeks)
- Patient Global Assessment, Change From Baseline(Baseline and 16 weeks)
- Physician Global Assessment, Change From Baseline(Baseline and 16 weeks)
- Tender Joint Count, Change From Baseline(Baseline and 16 weeks)
- Swollen Joint Count, Change From Baseline(Baseline and 16 weeks)
研究者
Eun Bong Lee
Professor
Seoul National University Hospital