Idiopathic Pulmonary Fibrosis Cohort Studies of Chinese Medicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Annual acute exacerbation rate
研究概览
简要总结
This study, based on past registration records, evaluates the clinical efficacy of traditional Chinese medicine in treating IPF in the real world, identifies advantageous populations and clinical targets, and provides references for precision traditional Chinese medicine treatment.
详细描述
This study is based on a previously established registry of interstitial lung disease, with traditional Chinese medicine treatment as the exposure factor. A total of at least 1000 IPF patients will be continuously enrolled and followed up for 2 years; it will further observe the pattern of syndromes, disease characteristics, and their interrelationships during disease development, and evaluate the clinical efficacy of traditional Chinese medicine in treating IPF using indicators such as annual acute exacerbation rate and clinical symptoms. Based on the differences in efficacy indicators, it will identify the advantageous population, clarify the clinical efficacy advantage targets, and provide a basis for precision treatment with traditional Chinese medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with IPF;
- •Age ≥ 40 years old;
- •Voluntary participation in this study,And sign the informed consent form.
排除标准
- •Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
- •Patients who are unable to take care of themselves and have been bedridden for a long time.
研究组 & 干预措施
Non-Traditional Chinese Medicine cohort
Other IPF patients who do not meet the inclusion criteria for traditional Chinese medicine cohort, are classified into the non-traditional Chinese medicine cohort.
干预措施: Non-traditional Chinese medicine (non-TCM) (Drug)
Traditional Chinese Medicine cohort
IPF subjects who have continuously used traditional Chinese medicine for standardized treatment for 3 months or more within 1 year, or have accumulated treatment time for 6 months or more, are classified into the traditional Chinese medicine cohort.
干预措施: Traditional Chinese medicine (TCM) (Drug)
结局指标
主要结局
Annual acute exacerbation rate
时间窗: Up to week 104
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
次要结局
- Lung transplantation rate(Up to week 104.)
- The Traditional Chinese Medicine(TCM) Syndromes(Evaluate the TCM s]yndromes at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)
- FVC as the percentage of the predicted value (FVC%)(Evaluate the FVC% at baseline and at weeks 26, 52, 78 and 104.)
- Forced vital capacity (FVC)(Evaluate the FVC at baseline and at weeks 26, 52, 78 and 104.)
- Diffusing capacity of the lungs for carbon monoxide (DLCO)(Evaluate the DLCO at baseline and at weeks 26, 52, 78 and 104.)
- DLCO as the percentage of the predicted value (DLCO%)(Evaluate the DLCO% at baseline and at weeks 26, 52, 78 and 104.)
- Clinical symptoms and Signs(Evaluate the clinical symptoms and signs up at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)
- All-cause mortality rate(Up to week 104.)
- A Tool to Assess Quality of life (ATAQ-IPF) total scores(Evaluate the ATAQ-IPF total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)
- St. George's respiratory questionnaire (SGRQ) total scores(Evaluate the SGRQ total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)
- Dyspnea(Evaluate the mMRC total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)
- C-reactive protein (CRP)(Evaluate the CRP level at baseline and at weeks 26, 52, 78 and 104.)
- Krebs Von den Lungen-6(KL-6)(Evaluate the KL-6 level at baseline and at weeks 26, 52, 78 and 104.)
- The pulmonary artery systolic pressure (PASP)(Evaluate the PASP at baseline and at weeks 26, 52, 78 and 104.)
- The diameter of the pulmonary artery(Evaluate the diameter of the pulmonary artery at baseline and at weeks 26, 52, 78 and 104.)
- Progression-Free Survival(PFS）(Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)
- 6 Six Minute Walk Distance(6MWD)(Evaluate the 6MWD at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)
- The 30 - second sit - to - stand test(30s STS)(Evaluate the 30s STS at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.)