Modified Maimendong Decoction in the Treatment of Patients with Idiopathic Pulmonary Fibrosis: Study Protocol for a Randomized Controlled Trial

Phase 1

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: ITMCTR2000003871
• Lead Sponsor: Hospital of Chengdu University of traditional Chinese Medicine

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. Between the ages of 18 and 75, male and female;
2. Diagnosis according to guidelines of the Idiopathic Pulmonary Fibrosis by ATS/ERS/JRS/ALAT in 2018;
3. In line with the diagnostic criteria of TCM syndrome Qi and Yin deficiency;
4. Good ability to read, understand and write research-related materials, and voluntary compliance with all testing requirements;
5. Volunteer for a study, sign an informed consent.

Exclusion Criteria

1. Patients with acute exacerbation of IPF or those with FVC% < 50% or those with obvious pulmonary infection should be treated with anti-infection therapy;
2. Patients with chronic obstructive pulmonary disease, interstitial lung disease, active pulmonary tuberculosis, bronchiectasis and other chronic lung diseases that need intervention or treatment;
3. Patients with severe mental and psychological disorders, cardiovascular, liver and kidney, endocrine, hematopoietic system, malignant tumor and other serious primary diseases;
4. Patients who had taken glucocorticoid within 1 month; those who had taken immunosuppressants within 1 month; those who had taken Pirfenidone, Nintedanib or antacid within 1 month;
5. Patients who are unwilling or unable to change the current treatment plan;
6. Patients who are known to be allergic to the test drug or some traditional Chinese medicine in the test drug;
7. Women in lactation, pregnancy or preparing for pregnancy;
8. Patients who have participated in other clinical studies in recent six months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Forced vital capacity;Times of acute exacerbation;

Secondary Outcome Measures

Name	Time	Method
BNP;SGRQ score;TCM syndrome score;DLCO;FEV1/FVC;