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

Not Applicable

• Conditions: Pulmonary fibrosis

• Registration Number: ITMCTR2200006437
• Lead Sponsor: The First Affiliated Hospital of Henan University of CM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annual decline rate of FVC;

Secondary Outcome Measures

Name	Time	Method
Annual acute exacerbations;6MWT;Quality of life;Progression-free survival;Severity of dyspnea;Health-related quality of life;Clinical symptoms;All cause mortality;