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Efficacy and safety of Buyang Huanwu Decoction in Idiopathic Pulmonary Fibrosis: A multicenter, Randomized Controlled Clinical Trial

Efficacy and safety of Buyang Huanwu Decoction in Idiopathic Pulmonary Fibrosis: A multicenter, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005765
Enrollment
Unknown
Registered
2022-03-26
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis

Interventions

Treatment group:Buyang Huanwu Decoction
Control group:Placebo

Sponsors

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Therapeutic response rate;

Secondary

MeasureTime frame
TGF-ß1;Change in FVCfrom baseline;MMP9;KBILD score change value;HYP;

Countries

China

Contacts

Public ContactFei Wang
wangfei896@163.com189 8088 0213

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026