Kangxianhuanji Granules in the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis: a Randomized, Controlled Exploratory Clinical Study
- Conditions
- AE-IPF
- Registration Number
- ITMCTR1900002632
- Lead Sponsor
- The First Affiliated Hospital of Henan University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the treatment failure rate;mortality;
- Secondary Outcome Measures
Name Time Method intubation rate;acute exacerbation rate;mMRC;the length of hospital stay;quality of life;arterial blood gas analysis;