Multicenter prospective randomized controlled trial for Dong-Tian Chang-Chun Ointment in the treatment of stable COPD patients

Phase 1

• Conditions: Chronic obstructive pulmonary disease; J44.8

• Registration Number: ITMCTR2000003075
• Lead Sponsor: Zhongshan Hospital Affiliated Fudan University ; Shuguang Hospital Affiliated to Shanghai 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. Patients who meet the western medicine diagnosis, classification, and stage diagnosis are included patients;
2. History of 1 to 3 acute exacerbations in the past 12 months;
3. Aged 40 to 80 years;
4. The syndrome differentiation of TCM belongs to the syndrome of deficiency of lung qi, deficiency of lung and spleen, deficiency of lung and kidney, and deficiency of both lung and kidney;
5. Voluntarily receive treatment and sign the informed consent.

Exclusion Criteria

1. Those who do not meet the above-mentioned western medical diagnosis, staging diagnosis and traditional Chinese medicine diagnosis standards;
2. Examination confirms chronic cough caused by tuberculosis, fungi, tumors, irritating gas allergies and other factors;
3. Patients with other respiratory diseases that can cause asthma or dyspnea;
4. pregnant or lactating women, allergic to Symbio 9ug / 320ug and Dongtian Changchun cream;
5. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental illness;
6. Concurrent severe heart dysfunction;
7. Contains factors that affect the observation of efficacy;
8. Those who do not meet the inclusion criteria, fail to use the drug as prescribed, cannot determine the efficacy or incomplete data, etc., which affect the efficacy or safety judgment;
9. Those who are participating in other clinical trials within 1 month before enrollment;
10. Patients with diabetes.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
SGRQ;Number of acute attacks;TCM Syndrome Effect;

Secondary Outcome Measures

Name	Time	Method
Single-cell gene sequencing and mass spectrometry examination;mMRC;6MWT;pulmonary function;