TCM Syndrome Differentiation Treatment on Reducing the Rehospitalization Rate of Discharged Elderly Patients With CAP:A Multi-center, Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Rehospitalization rate
研究概览
简要总结
This study is to evaluate the efficacy and safety of TCM syndrome differentiation treatment on the rehospitalization rate of discharged elderly patients with community acquired pneumonia(CAP)and to explore its mechanism.
详细描述
The incidence and mortality of elderly patients with CAP are on a rising trend, especially the mortality of those over 65 years old are the highest. The elderly patients with CAP have more complications and drug resistance, which makes it difficult to treat and have heavy burden on the society. The discharged elderly patients with CAP are still facing the risk of readmission or even death due to recurrent pneumonia or other reasons. Research reports showed that TCM syndrome differentiation treatment had a certain role in improving the condition of discharged elderly patients with CAP. Our previous exploratory studies suggested that TCM syndrome differentiation treatment on the discharged elderly patients with CAP had good clinical efficacy and safety.
This is a multi-center, randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of TCM syndrome differentiation on the rehospitalization rate of discharged elderly patients with CAP and to explore its mechanism. 292 patients will be randomly assigned in a 1:1 ratio to experimental group or control group for 2 months treatment and 6 months follow-up.The experimental group will be given by Bu Fei Jian Pi Hua Tan granule or Yi Qi Yang Yin Qing Fei granule based on TCM syndrome differentiation. The primary outcomes are rehospitalization rate. The secondary outcomes include mortality, assessment of disease severity(CURB65 scores),quality of life (SF-36), treatment satisfaction(ESQ-CAP),Clinician Reported Outcome for CAP,Patient Reported Outcome for CAP,nutritional status (MNA-SF).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of discharged elderly patients with CAP within 1 weeks;
- •Syndrome differentiation meets criteria of syndrome of the lung and spleen qi deficiency and unclean phlegm dampness, Syndrome of qi and yin deficiency and unclean phlegm heat;
- •Age including or above 65 years old;
- •Voluntary treatment, oral medication;
- •With informed consent signed.
排除标准
- •A confirmed diagnosis of discharged elderly patients with severe CAP;
- •Patients with unconscious, dementia or mental disorders;
- •Patients with hydrothorax, bronchiectasis, active pulmonary tuberculosis, pulmonary abscess, chronic obstructive pulmonary disease of GOLD D;
- •Patients with aspiration risk of severe neuromuscular disorders and long-term bedridden;
- •Patients with tumor, severe cardiovascular disease and severe liver and kidney diseases;
- •Participants in clinical trials of other drugs;
- •People who are allergic to the treatment drugs.
研究组 & 干预措施
Traditional Chinese medicine granules
The experimental group will be given Bu Fei Jian Pi Hua Tan granule or Yi Qi Yang Yin Qing Fei granule based on TCM syndrome differentiation.
干预措施: Traditional Chinese medicine granules (Drug)
Traditional Chinese medicine granules placebo
The control group will be given Bu Fei Jian Pi Hua Tan granule placebo or Yi Qi Yang Yin Qing Fei granule placebo based on TCM syndrome differentiation.
干预措施: Traditional Chinese medicine granules placebo (Drug)
结局指标
主要结局
Rehospitalization rate
时间窗: up to month 8.
Rehospitalization and causes of rehospitalization during the study period will be recorded.
次要结局
- ESQ-CAP(Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.)
- Mortality(the month1,2 of treatment period and month3, 6 of follow-up period.)
- CURB65 score(Before treatment, the month 2 of treatment period and month 6 of follow-up period.)
- MNA-SF(Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.)
- CAP-PRO(Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.)
- CAP-CRO(Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.)
- SF-36(Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.)