Clinical trial NCT04187690: Jin-shui Huan-xian Granule in the Treatment of IPF
Official title: Efficacy and Safety of Jin-shui Huan-xian Granule in the Treatment of IPF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
traditional Chinese medicine
randomized controlled trial
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 312
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequencies of acute exacerbations (AEs)
timeFrame: up to 52 weeks.
measure: Six-minute walking distance(6MWD)
timeFrame: Change from baseline 6MWD at week 13, 26, 39 and 52
measure: Proportion of progressive-free survival
timeFrame: up to week 13, 26, 39 and 52.
Secondary outcomes:
measure: Pulmonary function
timeFrame: Change from baseline FVC and DLco% at week 26 and 52.
measure: All-cause mortality
timeFrame: up to 52 weeks.
measure: Clinical symptoms and Signs
timeFrame: Change from baseline clinical symptoms assessment questionnaire scores at week 13, 26, 39 and 52.
measure: Dyspnea
timeFrame: Change from baseline mMRC scores at week 13, 26, 39 and 52.
measure: COPD assessment test (CAT)
timeFrame: Change from baseline CAT scores at week 13, 26, 39 and 52.
measure: 36-item short-form health survey (SF-36) total scores
timeFrame: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
measure: St. George's respiratory questionnaire (SGRQ) total scores
timeFrame: Change from baseline SGRQ scores at week 13, 26, 39 and 52.
measure: A Tool to Assess Quality of life in IPF(ATAQ-IPF)
timeFrame: Change from baseline ATAQ scores at week 13, 26, 39 and 52.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the First Affiliated Hospital of Henan University of Chinese Medicine
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jian-sheng Li, Professor
role: STUDY_CHAIR
References:
citation: Yang SG, Yu XQ, Li JS, Xie Y, Zhang W, Ban C, Feng J, Wu L, Lu X, Zhao L, Meng Y, Zhou M, He Y, Luo W. Efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2022 Sep 2;23(1):725. doi: 10.1186/s13063-022-06684-0.