NCT01794260Unknown2 期
Efficacy and Safety of Topical Preparation of Essential Oil Extracted From Zingiber Cassumunar Rokb in Patients With Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index
研究概览
简要总结
The objectives of this study are to assess short term efficacy and safety of of topical preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering from osteoarthritic pain
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (Kellgren-Lawrence radiographic grading scale at least 1)
- •Pain visual analog scale at rest at least 40 mm
- •No previous analgesic treatment or receiving stable dose of analgesic drugs at least 2 weeks. If previously treated with antidepressants, glucosamine, chondroitin or diacerein, dosage should be stable for at least 3 months.
- •Agree to attain non-pharmacologic treatment as prior to participate the study
排除标准
- •having an open wound or abnormal skin at site of application
- •having diagnose with other chronic arthritis such as rheumatoid arthritis
- •history of allergy to the extraction of Zingiber cassumunar Roxb
- •pregnancy or breastfeeding
研究组 & 干预措施
Plai cream
Experimental
Cream from Zingiber cassumunar Roxb. extract
干预措施: Cream from Zingiber cassumunar Roxb. extract (Drug)
Placebo cream
Placebo Comparator
Placebo cream
干预措施: Placebo cream (Drug)
结局指标
主要结局
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index
时间窗: week 8
次要结局
- Change from baseline of Pain visual analog scale (PVAS)(week 8)
- Change from baseline of Global assessment of disease status (GADS)(week 8)
- Clinical global impression of change (CGIC)(Week 8)
- Patient global impression of change (PGIC)(Week 8)
- Adverse events(Week 8)
研究者
研究点 (1)
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