Observation Study on the Efficacy of Yiqi Gubiao Pill in the Treatment of Chronic Obstructive Pulmonary Disease Secondary to Active Pulmonary Tuberculosis: A Double-Blind Randomized Controlled Trial Protocol
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 主要终点
- Forced Vital Capacity
研究概览
简要总结
Tuberculosis-related obstructive pulmonary disease (TOPD), as a high-burden disease in most countries, poses difficulties in the diagnosis and treatment of the disease when coexisting, and increases the risk of death for patients. Preliminary studies have shown that Yiqi Gubiao Wan has significant effects in relieving cough, alleviating asthma, expectorating phlegm, and delaying airway obstruction. The purpose of this study is to verify the therapeutic effect of Yiqi Gubiao pill on patients with TOPD through rigorous methodological design and to evaluate its safety. We will conduct a prospective, double-blind, randomized controlled trial. First, participants will be randomly assigned 1:1 to the Yiqi Gubiao pill treatment group and the Yiqi Gubiao pill placebo control group. This will be followed by a 12-week treatment. During the treatment period, we will measure and record the patients' lung function and quality of life. We will also score the patients' TCM symptoms. Finally, the safety of the medication will be assessed.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following criteria will be included:
- •Age 40-75 years old;
- •Meet the Western medical diagnostic criteria and typing standards for active PTB;
- •Patients who have not taken steroids, anti-tuberculosis drugs, or other immunosuppressants and have not undergone desensitization treatment within one month.
- •Have understood the treatment methods and voluntarily signed the informed consent form.
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •Patients with pneumothorax, pleural effusion, lung cancer and other serious lung diseases;
- •Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases;
- •mentally ill;
- •Patients with tumors;
- •Congenital or acquired immunodeficiency.
研究组 & 干预措施
Yiqi Gubiao pill
干预措施: Yiqi Gubiao pill (Drug)
Yiqi Gubiao Pill placebo
干预措施: Yiqi Gubiao Pill placebo (Drug)
结局指标
主要结局
Forced Vital Capacity
时间窗: up to 4 weeks
Forced Vital Capacity (FVC) refers to the volume of air exhaled as quickly and forcefully as possible after taking the maximum inhalation.
the percentage of FVC predicted
时间窗: up to 4 weeks
The volume of air exhaled rapidly within one second after inhaling to the total lung capacity. Normal values are 70-85%, mild is less than 80% of the predicted value; moderate is less than 70% of the predicted value; moderately severe is less than 60% of the predicted value; severe is less than 50% of the predicted value.
the ratio of FEV1 to FVC
时间窗: up to 4 weeks
The ratio of FEV1 to FVC should be above 70%. If the ratio is below 70%, it may indicate the presence of chronic obstructive pulmonary disease (COPD).
COPD Assessment Test (CAT) score
时间窗: up to 4 weeks
The CAT score questionnaire is primarily used to assess the health status and impact on daily life of patients with chronic obstructive pulmonary disease (COPD). It quantifies the degree of health impairment in COPD patients by asking questions related to symptoms, activity ability, mental state, and social impact based on the patients' self-reports. The total score of the CAT questionnaire ranges from 0 to 40, with higher scores indicating poorer health status and lower quality of life for the patients.
modified Medical Research Council (mMRC) score
时间窗: up to 4 weeks
The mMRC is only used for the assessment of dyspnea and is often applied in conjunction with the CAT score. An mMRC score of 2 or above is the threshold for distinguishing "mild dyspnea" from "severe dyspnea."
Baseline Dyspnea Index (BDI) score
时间窗: up to 4 weeks
It measures activity-related dyspnea from three dimensions: degree of functional impairment, amount of activity, and effort required to complete activities. Each dimension is graded on a 5-level scale, with scores ranging from 0 to 4, indicating increasing severity. The total score ranges from 0 to 12.
Transition Dyspnea Index (TDI) score
时间窗: up to 4 weeks
The TDI should be used in conjunction with the BDI to measure the extent of change in prognostic functional impairment, activity level, and effort required to complete activities. The TDI scores each dimension on a scale from significantly worse (-3) to significantly better (+3), with a total score ranging from -9 to +9.
次要结局
- Traditional Chinese Medicine (TCM) symptom score(up to 4 weeks)
- alanine aminotransferase(up to 4 weeks)
- aspartate aminotransferase(up to 4 weeks)
- urea nitrogen(up to 4 weeks)
- serum creatinine(up to 4 weeks)
- uric acid(up to 4 weeks)
研究者
Jin Dai
Attending Physician
Fourth Affiliated Hospital of Xinjiang Medical University