Efficacy and safety of Buyang Huanwu Decoction in Idiopathic Pulmonary Fibrosis: A multicenter, Randomized Controlled Clinical Trial
- Conditions
- Idiopathic pulmonary fibrosis
- Registration Number
- ITMCTR2200005765
- Lead Sponsor
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
? In line with the IPF diagnostic criteria set by the 2018 ATS/ERS/JRS/ALAT Diagnostic Guidelines:
1) HRCT showed common interstitial pneumonia: honeycombs with subpleural and basal lung distribution, with or without peripheral tractive bronchiectasis.
2) HRCT classification was probable or uncertain UIP, and histopathological classification was consistent with UIP: dense fibrosis with structural twist (i.e., destructive scar and/or honeycomb change), fibrosis mainly distributed subpleural and/or para-septal, patchy fibrosis involved in pulmonary parenchyma, and fibroblast foci; Or probably UIP
Either 1) or 2) corresponds to pulmonary fibrosis;
(2). In line with the TCM syndrome differentiation for qi stagnation and blood stasis syndrome: main symptoms: fatigue, fatigue, less qi lazy speech, cough and weak, phlegm white; Chest tightness, asthma, increased after activity, progressive, pulse heavy and astringent; Secondary symptoms: pale complexion, shortness of breath, palpitation and spontaneous sweating; Tongue image: the tongue is dark or petechiae, thin white or greasy white moss; Pulse: fine slow or fine astringent;
? The age range is 18-85;
? Patients voluntarily participated in the experiment and signed the informed consent
1) Complicated with serious primary diseases of other systems, including malignant tumors, hematologic diseases, thyroid diseases, and serious cardiovascular and cerebrovascular diseases; He had a recent cardiovascular accident
2) Recent surgery that may have secondary bleeding events
3) Severe liver and kidney dysfunction
4) The presence of alcohol or drug abuse or dependence
5) Highly sensitive or allergic to prescribed drugs
6) Participants in other clinical studies in the last month taking other drugs that may interfere with the results
7) People with mental, intellectual, cognitive or language disabilities
8) Pregnant and lactating women
9) Those who are considered unsuitable to participate in the clinical trial by the researcher, including those who are judged by the researcher to have poor compliance or live far away from the subject and cannot follow up on schedule
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapeutic response rate;
- Secondary Outcome Measures
Name Time Method TGF-ß1;Change in FVCfrom baseline;MMP9;KBILD score change value;HYP;