Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
312 participants
INTERVENTIONAL
2020-09-01
2023-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Jin-shui Huan-xian granule
Participants in this arm will be given Jin-shui Huan-xian granule.
Jin-shui Huan-xian granule
Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.
Jin-shui Huan-xian granule placebo
Participants in this arm will be given Jin-shui Huan-xian granule placebo.
Jin-shui Huan-xian granule placebo
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.
Interventions
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Jin-shui Huan-xian granule
Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.
Jin-shui Huan-xian granule placebo
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
85 Years
ALL
No
Sponsors
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Henan University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Jian-sheng Li, Professor
Role: STUDY_CHAIR
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Locations
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the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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TCM for IPF
Identifier Type: -
Identifier Source: org_study_id
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