An interventional study of Jin-shui Huan-xian granule and Jin-shui Huan-xian granule placebo in Idiopathic Pulmonary Fibrosis, sponsored by Henan University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Henan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 312 is above the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 53 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Participants in this arm will be given Jin-shui Huan-xian granule.
Drug: Jin-shui Huan-xian granule
Participants in this arm will be given Jin-shui Huan-xian granule placebo.
Drug: Jin-shui Huan-xian granule placebo
Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.
Jin-shui Huan-xian granule placebo will also be administered 5days on and 2 days off for 52 weeks. The placebo consists 5% of the same components as Jin-shui Huan-xian granule besides dextrin and bitter. The There is no obvious difference in appearance, weight and odor between Jin-shui Huan-xian granule and placebo.
Frequencies of acute exacerbations (AEs)
It will be assessed by frequencies of AEIPF-related hospitalizations.
Time frame: up to 52 weeks.
Six-minute walking distance(6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Time frame: Change from baseline 6MWD at week 13, 26, 39 and 52
Proportion of progressive-free survival
Endpoints of Progressive-free survival include FVC decreased by 10% compared with baseline, or DLCO% decreased by 15%, or death or lung transplantation.
Time frame: up to week 13, 26, 39 and 52.
Pulmonary function
Forced vital capacity (FVC) and diffusing capacity percentage of the predicted value (DLco%) will be applied to assess pulmonary function.
Time frame: Change from baseline FVC and DLco% at week 26 and 52.
All-cause mortality
The all-cause mortality will be calculated in each group at the end of the trial.
Time frame: up to 52 weeks.
Clinical symptoms and Signs
Assessment will be performed by clinical symptom assessment questionnaire. The clinical symptoms to be evaluated in this study include cough, expectoration, chest tightness, shortness of breath, wheezing and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Time frame: Change from baseline clinical symptoms assessment questionnaire scores at week 13, 26, 39 and 52.
Dyspnea
Dyspnea will be assessed by modified Medical Research Council (mMRC) scores set up by American Thoracic Society. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse dyspnea.
Time frame: Change from baseline mMRC scores at week 13, 26, 39 and 52.
COPD assessment test (CAT)
CAT will be used to evaluate quality of life. A total score of 0-40 will be given with a higher score indicating a worse condition.
Time frame: Change from baseline CAT scores at week 13, 26, 39 and 52.
36-item short-form health survey (SF-36) total scores
SF-36 total scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the better outcomes.
Time frame: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
St. George's respiratory questionnaire (SGRQ) total scores
SGRQ total scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes.
Time frame: Change from baseline SGRQ scores at week 13, 26, 39 and 52.
A Tool to Assess Quality of life in IPF(ATAQ-IPF)
ATAQ-IPF will be used to evaluate quality of life. There are 13 domains with 74 items with a score of 1-5 for each item. A higher score will indicate a worse health.
Time frame: Change from baseline ATAQ scores at week 13, 26, 39 and 52.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis →
Henan University of Traditional Chinese Medicine