The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The relief of symptoms
研究概览
简要总结
This research is based on spleen trapped by dampness and turbid which is the pathogenesis of gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In this study, the investigators use multi-center randomized parallel controlled clinical trials.The treatment groups are afforded oral traditional Chinese medicine decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a positive control drug.The outcome is evaluated by condition of symptoms remission,pain relief time, recurrence rate and laboratory index to determine the efficacy of internal and external treatment.And the research will provide optimized diagnosis and treatment program. The investigators hope this research will also get tonifying spleen and descending the turbid internal and external treatment for gouty arthritis effective clinical treatment.
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
- 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
- •Aged 18-75, and gender unlimited;
- •The patients must meet western medicine diagnostic criteria for acute gouty arthritis;
- •The patients must meet that integral syndrome differentiation conforms to the spleen beset by dampness syndrome and local syndrome differentiation conforms to blockage disease due to heat.
排除标准
- •Secondary hyperuricemia, such as cancer and perichemotherapy of leukemia, renal failure, cirrhosis of the liver and drug effect(such as diuretics, aspirin, antitubercular agents), et al.
- •Acute infectious diseases, stroke, acute myocardial infarction ,as well as other acute diseases and tumors, rheumatoid arthritis.
- •Patients with peptic ulcer and gastrointestinal bleeding.
研究组 & 干预措施
treatment group
Take oral medicine of tonifying spleen and descending turbid, one bag each time, two times a day, continuous treatment for 10 days.The onset of the joints afford steeping washing and wet wrapping medicine of descending turbid and clearing heat, once per day, continuous treatment for 10 days.
干预措施: Oral medicine of tonifying spleen and descending turbid (Drug)
treatment group
Take oral medicine of tonifying spleen and descending turbid, one bag each time, two times a day, continuous treatment for 10 days.The onset of the joints afford steeping washing and wet wrapping medicine of descending turbid and clearing heat, once per day, continuous treatment for 10 days.
干预措施: Steeping and washing medicine of descending turbid and clearing heat (Drug)
treatment group
Take oral medicine of tonifying spleen and descending turbid, one bag each time, two times a day, continuous treatment for 10 days.The onset of the joints afford steeping washing and wet wrapping medicine of descending turbid and clearing heat, once per day, continuous treatment for 10 days.
干预措施: Wet wrapping medicine of descending turbid and clearing heat (Drug)
Control group
Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.
干预措施: diclofenac sodium enteric-coated (Drug)
结局指标
主要结局
The relief of symptoms
时间窗: After take the drug 10 days
This measure is a composite outcome according to the joint red and swollen, joint pain, and restricted movement(Excellent:Complete resolution of symptoms, joint function returning to normal. The score of joint pain, joint red and swollen and joint motion is 0.Effective:The main symptoms mostly disappear. Joint function is improvement, but still have the joint red,swollen,pain and limited activity.Invalid: There is no improvement compared with before treatment).The unit of measure is scale.
The gout relief index
时间窗: After take the drug 10 days
The gout relief index = \[gout relief time (days) ÷ 10 (days)\] x 100%.The unit of measure is scale.
Compare scores of syndrome before treatment and after it.
时间窗: After take the drug 10 days
Using nimodipine method: nimodipine = \[(scores of syndrome before treatment minus score after it) ÷scores of syndrome before treatment\] x 100%.The unit of measure is scale.
次要结局
- Recurrence rate(Following up for 1 month)
- Recurrence time(Following up for 1 month)
- The dosage of colchicine of two groups in observation period(After take the drug 10 days)
- Blood uric acid before and after the treatment.(After take the drug 10 days)
- White blood cell count before and after the treatment.(After take the drug 10 days)
- Erythrocyte sedimentation rate before and after the treatment.(After take the drug 10 days)
研究者
Wang Shidong
Beijing University of Chinese Medicine
Beijing University of Chinese Medicine