Jin-shui Huan-xian Granule in the Treatment of IPF

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    312
  • sponsor
    Henan University of Traditional Chinese Medicine
Updated on 26 January 2021

Summary

This study is to evaluate the efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis (IPF), establish the treatment scheme, and obtain the high quality clinical evidences.

Description

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive and ultimately fatal interstitial lung disease. With worsened dyspnea and an increasing loss of pulmonary function, IPF patients will have very poor quality of life. It has also brought an increasing social-economic burden. Researches show that pirfenidone and nintedanib could be effective to IPF, which were also recommended by the guideline. However, the application has been limited by side effects and high prices. It is urgent to develop other effective treatments and strategies to manage IPF. The investigators' previous studies shown that Jin-shui Huan-xian granule could be effective to IPF.

This is a multicerter, randomized, double-blind, placebo-controlled trial to assess the efficacy of Jin-shui Huan-xian granule in reducinig the acute exacerbations, improving exercise capacity, and delaying the disease progression for IPF. After a 2-week wash-out period, 312 patients will be randomly assigned into treatment or control group for 52-week treatment. The primary outcomes are frequencies of acute exacerbation, 6-minute walking test, and percentage of patients with progression-free survival. The secondary outcomes include pulmonary function, all-cause mortality, clinical symptoms, dyspnea score, and quality of life. Safety will also be evaluated.

Details
Condition Pulmonary Fibrosis, Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment Jin-shui Huan-xian granule, Jin-shui Huan-xian granule placebo
Clinical Study IdentifierNCT04187690
SponsorHenan University of Traditional Chinese Medicine
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A confirmed diagnosis stable IPF
Age ranges from 40 years to 85 years
TCM Syndrome differentiation meets criteria of pattern of Lung Qi deficiency, yin deficiency and inter heat, and lung-kidney qi deficiency
Without participanting in any other trial
With signed informed consent

Exclusion Criteria

Pregnant, nursing or may become pregnant women
Patients with unconscious, dementia or mental disorders
Patients with severe cardiac dysfunction
Patients with severe liver and kidney diseases
Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic obstructive pulmonary disease, chronic respiratory failure or other severe respiratory diseases
Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years
Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases
Patients with long-term bedridden
Patients who are allergic to any of the treatment drugs
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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