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Kangxianhuanji Granules in the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis: a Randomized, Controlled Exploratory Clinical Study

Kangxianhuanji Granules in the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis: a Randomized, Controlled Exploratory Clinical Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002632
Enrollment
Unknown
Registered
2019-09-29
Start date
2019-10-01
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

AE-IPF

Interventions

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) A confirmed diagnosis of AE-IPF; (2) Aged between 40 and 80 years; (3) Without participations in other interventional trials in the previous one month; (4) With the informed consent signed.

Exclusion criteria

Exclusion criteria: (1) Pregnant and lactating women; (2) Dementia, mental disorders and reluctant partners; (3) Complicated with heart failure (NYHA Class IV), or unstable hemodynamics, or hypertension (Grade-4), or serious cardiac arrhythmias (e.g., ventricular tachycardia, paroxysmal supraventricular tachycardia, ventricular flutter and ventricular fibrillation); (4) Complicated with Other diseases (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function); (5) Treated outside the hospital for more than 7 days; (6) Need to carry out invasive mechanical ventilation respiratory failure; (7) Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation); (8) Bedridden for various reasons; (9) Allergic to the used medicine.

Design outcomes

Primary

MeasureTime frame
the treatment failure rate;mortality;

Secondary

MeasureTime frame
intubation rate;acute exacerbation rate;mMRC;the length of hospital stay;quality of life;arterial blood gas analysis;

Countries

China

Contacts

Public ContactZhang Hailong

The First Affiliated Hospital of He'nan University of Chinese Medicine

zhanghailong6@126.com+86 13643718969

Outcome results

None listed

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