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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04187690
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Henan University of Traditional Chinese Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jian-sheng Li, Professor
Principal Investigator Affiliation	The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Jin-shui Huan-xian granule

Participants in this arm will be given Jin-shui Huan-xian granule.

Placebo Comparator: Jin-shui Huan-xian granule placebo

Participants in this arm will be given Jin-shui Huan-xian granule placebo.

Interventions

Drug: - Jin-shui Huan-xian granule

Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.