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Effectiveness and safety evaluation of Chinese medicine in the treatment of patients with PPF with phlegm heat-blood stasis obstructing in the lung: a randomized controlled, open-label clinical trial

Effectiveness and safety evaluation of Chinese medicine in the treatment of patients with PPF with phlegm heat-blood stasis obstructing in the lung

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071734
Enrollment
Unknown
Registered
2023-05-23
Start date
2023-05-11
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

progressive pulmonary fibrosis(PPF)

Interventions

experimental group:Mahuang, Kuxingren, Gancao, Fengfang, Dilong, Chishao, Jiezi, Laifuzi, Zisuzi, Huangqi, Huangqin, Qinghao
control group:1. All patients will take pulmonary rehabilitation therapy
2. Patients with hypoxia at rest, will take long-term oxygen therapy
3. Patients with pulmonary infection will take empirical anti-infective treatment, and targeted anti-infective treatment will be given after obtaining the results of drug sensitivity test. For the dos
(2) Cyclophosphamide: adhere to the daily use of 2mg, the initial dose is prescribed daily oral 25mg-50mg, and increase 25mg every other week to two weeks, according to this cycle until the maximum do
(3) Azathioprine: administered at 2-3 mg·kg-1·d-1. The initial dose is 25-30mg/d, and then 25mg will be increased every 7 to 14 days until the maximum amount of 150mg/d is reached
In addition, if the subjects had taken oral corticosteroids for more than one month before entering the trial, and the hormone had reached the maintenance dose, or if they had taken oral immunomodulat

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18-80 years; 2. Patients meeting the diagnostic criteria for PPF in the 2022 latest ATS/ERS/JRS/ALAT diagnostic guideline; 3. Patients meeting the syndrome of phlegm heat-blood stasis obstructing in the lung; 4. Patients with the baseline lung function: FVC% >= 45%, DLCO >= 30% and < 80%; 5. Patients voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women, or those who are preparing to become pregnant while undergoing treatment; 2. Patients allergy to therapeutic drugs or components of therapeutic drugs; 3. Patients with other lung diseases such as combined asthma, tuberculosis, pulmonary embolism, pulmonary infarction, bronchiectasis, severe chronic obstructive pulmonary disease; 4. Patients with serious primary diseases such as severe cardiac insufficiency, abnormal liver and kidney function, disorders of the haematopoietic system, tumours of various organs, as well as those with a history of psychiatric disease and communication difficulties; 5. Patients with clinical evidence of active infection at other sites, e.g. urinary tract infection, acute gastroenteritis, cellulitis, etc.; 6. Patients unable to cooperate with spirometry; 7. Patients in other clinical trials within 1 month before our trial; 8. Patients who are judged unsuitable for this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Leicester Cough Questionnaire (LCQ);

Secondary

MeasureTime frame
The University of California, San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ);The Fatigue Assessment Scale (FAS);Forced Vital Capacity (FVC) decline value (absolute value, mL) and percentage (proportion, %);Carbon Monoxide Dispersion (DLco) decline value (absolute value, mL) and percentage (proportion, %);The six-minute walking distance;Visual Analogue Scales (VAS);

Countries

China

Contacts

Public ContactQingsong Huang

Hospital of Chengdu University of Traditional Chinese Medicine

huangqingsong5802@163.com+86 138 8033 6152

Outcome results

None listed

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