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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 2 November 2020
Main ID:  ChiCTR2000037602
Date of registration: 2020-08-29
Prospective Registration: No
Primary sponsor: Tianjin Medical University General Hospital
Public title: Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis
Scientific title: Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis
Date of first enrolment: 2020-01-01
Target sample size: 1:100;2:100;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=59849
Study type:  Interventional study
Study design:  Parallel  
Phase:  4
Countries of recruitment
China
Contacts
Name: Nana Liu   
Address:  354 Beima Road, Hongqiao District, Tianjin, China 300120
Telephone: +86 18622696720
Email: 920679678@qq.com
Affiliation:  Tianjin Medical University General Hospital
Name: Jing Feng   
Address:  Respiratory Medicine, 154 Anshan Road, Heping District, Tianjin, China 300052
Telephone: +86 13920500251
Email: fengjing1974@163.com
Affiliation:  Tianjin Medical University General Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. The patients who met the IPF diagnostic criteria of ATS / ERS / JRS / ALAT in 2018: HRCT accorded with UIP type and possible UIP type;
2. Patients aged 18 to 75 years;
3. Those patients who fully understand the treatment purpose and grouping method, and those who may have adverse reactions such as gastrointestinal discomfort, liver dysfunction, skin damage and so on, and sign the informed consent form.

Exclusion criteria: 1. Patients with allergy or intolerance to pirfenidone and dextromethorphan;
2. Patients who had used glucocorticoid or immunosuppressant within one month before enrollment;
3. Patients who have been used for a long time (>=2 weeks) with fibrogenic drugs such as amiodarone;
4. Patients with typical CTD-ILD.


Age minimum: 18
Age maximum: 75
Gender: Both
Health Condition(s) or Problem(s) studied
Interstitial lung disease
Intervention(s)
1:Dextromethorphan+Pirfenidone;2:Pirfenidone;
Primary Outcome(s)
Chest HRCT;Pulmonary Function;
Secondary Outcome(s)
blood routine, Liver Function,Renal Function;
Secondary ID(s)
Source(s) of Monetary Support
National Natural Science Foundation of China (No.81270144, 81570084, 30800507)
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/07/2020
Contact:
Zhang Zhixiang
+86 22-60361044
Results
Results available:
Date Posted:
Date Completed:
URL:
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