Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- whether endpoint such as renal damage or disease recurrence appears in the participants.
研究概览
简要总结
Due to high incidence of renal damage by Hench-schonlein Purpura(HSP) is the key to affect prognosis, this project moves the research emphasis forward in line with the idea of "prevention of progress of disease", Which concerns on Traditional Chinese Medicine(TCM) clinical research scheme evaluation of HSP, evaluates the renal damage and disease recurrence as the end event, and comes to the evaluation through the comparative study that the vantage point of the scheme of syndrome differentiation and treatment in detoxification, cooling blood and removing blood stasis to the conventional treatments can reduce kidney damage and recurrence rate.
详细描述
Target：Optimize the TCM scheme of syndrome differentiation and treatment of HSP in line with the idea of blood- Cooling - Toxin - Removing - Stasis - Dispersing under the path of combination between disease differentiation and syndrome differentiation, and regards reducing the rate of the recurrence of HSP and kidney damage as the end point of evaluation indexes, to evaluate the clinical efficacy of the scheme scientifically. Main research contents: Retrospective case investigation, analysis and research on literature, research on clinical assessment of the scheme of syndrome differentiation and treatment. Methods：With a series of compounds as the main interference factors, choosing the sample estimation of superiority design and adopting the test methods of randomized, double-blind, placebo-controlled to carry out the research of multicenter clinical efficacy evaluation.
It summarizes the advantages and rules of syndrome differentiation and treatment in TCM by means of the comparative study, which provides technical guidelines for the industry and sets an example to summarize the key common technology of clinical research, and also improves the evaluation level of TCM clinical research and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To comply with the diagnostic standard of purpura in TCM and Hench-schonlein purpura in western medicine;
- •To comply with the diagnostic standard of TCM syndrome differentiation;
- •Age between 5 and 18;
- •without similar herbal treatment a week before being included;
- •Informed Consent Form is required to be singed.
排除标准
- •Fall short of the diagnostic standard of purpura in TCM and Hench-schonlein purpura in western medicine;
- •Fall short of the diagnostic standard of TCM syndrome differentiation;
- •Older then 18 years or younger then 5years;
- •Take similar herbal treatment within a week before being included;
- •Can not take the drug according to the regulation or follow-up on time
- •Patients combine serious primary disease in respiratory、gastrointestinal、hemopoietic、renal，or psychosis,or pestilence;
- •Allergic to drugs of this research or others;
- •human subject of other clinical research in the nearly tow weeks.
研究组 & 干预措施
placebo
干预措施: Placebo (Drug)
Drug:"ziying"
干预措施: "ziying" granules (Drug)
结局指标
主要结局
whether endpoint such as renal damage or disease recurrence appears in the participants.
时间窗: 6 months
Endpoint is a mark of termination or completion. In this clinical research, the renal damage and disease recurrence that constitutes the target outcomes of the trial.
次要结局
- whether the TCM syndrome of participants disappears after treatment.(1 month)