A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Time to Clinical Stability
研究概览
简要总结
This study aims to evaluate the clinical efficacy of traditional Chinese medicine formula granules (Fei Re Qing Granules) in the treatment of elderly community-acquired pneumonia, establish a treatment protocol, and obtain high-level clinical evidence.
详细描述
This study evaluates the efficacy and safety of Fei Re Qing Granules for elderly community-acquired pneumonia (CAP) through a multicenter, randomized, double-blind, placebo-controlled trial.
Key elements of the trial include:
Design: Conducted across multiple centers, comparing treatment and placebo groups.
Participants: Patients aged 65-80 years diagnosed with CAP according to both Western and Traditional Chinese Medicine (TCM) diagnostic criteria.
Intervention:
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients diagnosed with community-acquired pneumonia (CAP) according to the diagnostic criteria.
- •Diagnosed with Phlegm-Heat Obstructing the Lungs syndrome based on Traditional Chinese Medicine (TCM).
- •Aged ≥65 and ≤80 years, regardless of gender.
- •Onset of illness within 72 hours.
- •Clinical symptoms must include at least two of the following four primary。symptoms: cough, sputum production, dyspnea, and pleuritic chest pain.
- •Voluntary participation and signed informed consent.
排除标准
- •Patients with altered mental status, consciousness disorders, dementia, or psychiatric disorders.
- •Patients requiring invasive mechanical ventilation or endotracheal intubation.
- •Patients with conditions such as pleural effusion, bronchiectasis, active pulmonary tuberculosis, pulmonary abscess, lung cancer, asthma, or chronic obstructive pulmonary disease (COPD).
- •Patients with neuromuscular diseases or those bedridden for long periods, posing a risk of aspiration.
- •Patients with cancer, severe cardiovascular diseases (acute myocardial infarction, heart failure stage III or above), or severe liver and kidney diseases (e.g., cirrhosis, portal hypertension with variceal bleeding, dialysis, or kidney transplantation).
- •Patients participating in other drug clinical trials or known to be allergic to the study medication.
研究组 & 干预措施
Test group
The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).
干预措施: Fei Re Qing Granules (Drug)
Test group
The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).
干预措施: Routine standard treatments (Other)
Control group
The patients in the control group received routine standard treatments, and Placebo granules
干预措施: Routine standard treatments (Other)
Control group
The patients in the control group received routine standard treatments, and Placebo granules
干预措施: Placebo granules (Drug)
结局指标
主要结局
Time to Clinical Stability
时间窗: From the start of treatment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to 2 weeks.
The criteria for clinical stability require meeting all five of the following indicators: Body temperature ≤ 37.8°C for more than 24 hours; Resting heart rate ≤ 100 beats per minute; Resting respiratory rate ≤ 24 breaths per minute; Systolic blood pressure ≥ 90 mmHg; Oxygen saturation (SpO₂) ≥ 90% (or arterial oxygen partial pressure ≥ 60 mmHg on room air). During the treatment period, log cards will be issued to monitor and record vital signs (temperature, respiration, blood pressure, heart rate, and SpO₂) every 12 hours. The time to clinical stability will be calculated based on these records
次要结局
- Confusion, Urea, Respiratory rate, Blood pressure, and Age ≥65 Score (CURB-65 score).(The CURB-65 score is assessed on Day 0, Day 4, Day 7, Day 14 (or at discharge) and during follow-up at 4 weeks and 12 weeks.)
- Traditional Chinese Medicine Syndrome Efficacy Evaluation(These evaluations will be carried out on Day 0, Day 4, Day 7, Day 14 (or at discharge).)
- Modified Pneumonia Imaging Absorption Evaluation Scale(The evaluations will be conducted on Day 0, Day 7 (or at discharge), and at 12 weeks during follow-up.)
- Comprehensive Clinical Efficacy Assessment(This evaluation will be conducted on Day 14 (or at discharge).)
- Pathogen Clearance Rate(This will be assessed at pre-treatment, Day 7, Day 14 (or at discharge) for each patient.)
- Readmission Rate(The readmission rate will be assessed at 4 weeks and 12 weeks during follow-up, with a detailed record of the reasons for readmission.)
- Improvement of Clinical Symptoms(Evaluations will be conducted on Day 0, Day 4, Day 7, Day 14 (or at discharge) and during follow-up at 4 weeks and 12 weeks.)
- Length of Hospital Stay(From the start of treatment, the time is recorded until the patient discharge, whichever came first, assessed up to 2 weeks.)