The Effect of Panax Notoginseng Powders on Rheumatic Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from Baseline in McGill Pain Questionnaire (MPQ) score at 24 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic Pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had a diagnosis of classic or definite RA
- •without conflict to the written, informed consent signed prior to the enrollment.
排除标准
- •uncontrolled medical problems
- •organic brain syndrome
- •major psychiatric disturbances
- •major communicative disorders
- •a history of severe noncompliance
- •less than 7 years of formal education, or illiteracy
- •being included in other clinical trial within the last 4 weeks
- •with abnormal liver or kidney function (more than 1 time above the high normal)
- •with serious cardiovascular disease
- •with hematologic disease
- •being in pregnancy, lactation period or under a pregnancy plan
- •with severe gastrointestinal disease
- •with contraindication or being allergic to the test drugs
- •being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs
- •being not compatible for the trial medication, or other circumstances at the discretion of investigators
- •without legal capacity or only with limited legal capacity
研究组 & 干预措施
Panax Notoginseng Powder 1g
Panax Notoginseng Powder 1g, daily
干预措施: Panax Notoginseng Powder 1g (Dietary Supplement)
Panax Notoginseng Powder 5g
Panax Notoginseng Powder 5g,daily
干预措施: Panax Notoginseng Powder 5g (Dietary Supplement)
Panax Notoginseng Powder 10g
Panax Notoginseng Powder 10g,daily
干预措施: Panax Notoginseng Powder 10g (Dietary Supplement)
Panax Notoginseng Powder 15g
Panax Notoginseng Powder 15g,daily
干预措施: Panax Notoginseng Powder 15g (Dietary Supplement)
Celecoxib Capsule 400 mg daily
Celecoxib Capsule 400 mg daily
干预措施: Celecoxib Capsule 400 mg daily (Drug)
结局指标
主要结局
Change from Baseline in McGill Pain Questionnaire (MPQ) score at 24 weeks
时间窗: at 0 week, 6 weeks, 12 weeks, 24 weeks
This well validated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
Change from Baseline in Visual Analog Scale(VAS) score at 24 weeks
时间窗: at 0 week, 6 weeks, 12 weeks, 24 weeks
This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no pain at all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain
次要结局
未报告次要终点
研究者
Yang Min
Ph.D
Chengdu PLA General Hospital