Study for metabolic biomarkers of asthmatic children and the therapeutic effect of Xiao-Er Xuan-Fei Ping-Chuan decoctio

Phase 1

Recruiting

• Conditions: asthma

• Registration Number: ITMCTR1900002759
• Lead Sponsor: Affiliated Hospital of Nanjing University of 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The inclusion criteria of the general observation group:
(1) those who meet the diagnostic criteria of Western Medicine issued by the Chinese Academy of Pediatrics for the diagnosis and prevention of children's bronchial asthma (2016 Edition);
(2) Aged 1 and 12 years old;
(3) informed consent, voluntary subjects. The process of obtaining informed consent shall be in accordance with the provisions of GCP.
The inclusion criteria of the treatment group:
(1) those who meet the diagnostic criteria of Western Medicine issued by the Chinese Academy of Pediatrics (2016 Edition), the treatment group should meet the syndrome differentiation criteria of traditional Chinese medicine;
(2) Aged 1 and 12 years old;
(3) those who have acute onset, the condition is mild or moderate according to the above scoring criteria; this asthma attack has not occurred. Use of any relevant treatment drugs;
(4) informed consent, voluntary subjects. The process of obtaining informed consent shall be in accordance with the provisions of GCP.

Exclusion Criteria

The exclusion criteria of the general observation group:
(1) other diseases that may cause asthma or dyspnea may affect the efficacy judgment;
(2) patients with primary diseases such as cardiovascular, cerebrovascular, hepatorenal and hematopoietic system;
(3) patients with age less than 1 year and age more than 12 years;
(4) patients who are participating in clinical trials of other drugs.
The exclusion criteria of the treatment group:
(1) stable or in remission stage;
(2) severe asthma, asthma status, critical patients, and patients with pulmonary infection;
(3) other diseases that may cause asthma or dyspnea may affect the efficacy judgment;
(4) patients with primary diseases such as cardiovascular, cerebrovascular, hepatorenal and hematopoietic system;
(5) medication not in accordance with the regulations Or the patients who are allergic to the components of this traditional Chinese medicine;
(6) the patients whose age is less than 1 year old and more than 12 years old;
(7) the patients who are participating in the clinical trials of other drugs.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
symptoms score;

Secondary Outcome Measures

Name	Time	Method
Metabolism of urine and feces;