NCT04544722Unknown不适用
Clinical Study of Jianfei Kangfu Cao in the Treatment of Primary Sjogren's Syndrome Associated Interstitial Lung Disease.
Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2020年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- FVC
研究概览
简要总结
This study will evaluate the safety and efficacy of Jianfei Kangfu Cao in the treatment of primary Sjogren's syndrome associated interstitial lung disease.
详细描述
This study will be a randomized, double-blind, positive control clinical trial with a course of 24 weeks.
- Random scheme:the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
- Blind method ：The test process will be in a double-blind state.
- Control drug: The lung rehabilitation training will be used as control in this 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the 2012 ACR classification of primary Sjogren's syndrome .
- •CT confirmed interstitial lung disease;
- •Stable treatment for at least 12 weeks;
- •Patients with good compliance should sign informed consent before the tria.
排除标准
- •The patient is using or has used anti pulmonary fibrosis drugs;
- •Pulmonary infection, tumor and other connective tissue diseases;
- •Chronic obstructive pulmonary disease, bronchial asthma and tuberculosis;
- •Patients with severe hypertension, diabetes and heart, liver and renal failure;
- •Women with reproductive needs;
- •Idiopathic pulmonary interstitial disease;
- •The researcher thinks that it is not suitable to participate in this experiment;
- •Participants in other clinical trials.
结局指标
主要结局
FVC
时间窗: 24 weeks
FVC is an index of lung function.
CAT score
时间窗: 24 weeks
Cat questionnaire includes eight questions, the core of which is cough, expectoration, chest tightness, sleep, energy, emotion, and two tolerance evaluation indexes, namely, exercise endurance and daily exercise influence. According to the patient's own situation, each item was scored accordingly (0-5), and the cat score range was 0-40
次要结局
- 6MWD(24 weeks)
- ESSDAI(24 weeks)
- ESSPRI(24 weeks)
研究者
研究点 (1)
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