Effects of Jinshui Huanxian granules for patients with PPF:A Multiceter,randomized,double-blind,placebo-controlled trial

The First Affiliated Hospital of Henan University of CM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1.Patients diagnosed with PPF;2.Aged 18 or older;3.Comply with TCM syndrome differentiation standards;4.Not participate in any other drug trial within one month prior to enrollment;5.FEV1/FVC=70% before bronchodilator use;6.FVC% predicted =45%;7.Dlco% predicted corrected for normal hemoglobin (Hb) normal = 30%–< 80%;8.Sign informed consent forms.

•1.Patients diagnosed with IPF;2.patients with confused,dementia,various mentally ill people and cannot communicate normally;3.Paitients with acute exacerbation of PPF ;4.Major extra-pulmonary physiologic limitation(eg chest wall abnormalities,massive of pleural effusion);5.Tumor before screening (except localized cancer such as basal cell carcinoma)within 5 year;6.Unstable or worsening heart disease within 6 months prior to screening,including but not limited to the following:myocardial infarction;unstable angina;congestive heart failure (requiring treatment in hospital or NYHA III/IV);uncontrolled severe cardiac arrhythmia;7.TBIL>1.2×ULN,AST or ALT>1.5×ULN;8.CLcr<60ml/min;9.Use of any of the following drugs to treat interstitial lung disease(ILD):strong inducers or strong CYP3A4 inhibitors within 4 weeks before randomization;Azathioprine (AZA),cyclosporine,MMF,combination of tacrolimus,oral corticosteroid(OCS)>20mg/ day,and OCS+AZA+NAC;cyclophosphamide within 8 weeks prior to randomization;Rituximab within 6 months prior to randomization;10.Unable to complete PFT,6MWT,or questionnaire;11.Pregnant or lactating women.

发起方