A Randomized controlled clinical study of Xiaoer Zhixiao Pingchuan Granule in the treatment of chronic duration of bronchial asthma in childre

Phase 1

• Conditions: bronchial asthma

• Registration Number: ITMCTR2200005683
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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) It meets the diagnostic criteria of children's bronchial asthma in Gina (2020 Edition), recommendations for standardized diagnosis and treatment of children's bronchial asthma (2020 Edition) and guidelines for diagnosis, prevention and treatment of children's bronchial asthma (2016 Edition) of Chinese Medical Association;
(2) The stage belongs to chronic duration, the severity classification belongs to intermittent state (Level 1) and mild persistence (Level 2) (see Table 2), and the patients with asthma are not well controlled (see Table 1); Traditional Chinese medicine syndrome belongs to wind Fu Lung collaterals, phlegm heat and blood stasis.
(3) Those who have not received standardized treatment (daily ICs or montelukast) within 3 months and have not taken drugs continuously every day for nearly 2 weeks;
(4) Asthma control test (ACT) score < 19 (see Table 3);
(5) 4 to 11 years old (including the boundary value at both ends), regardless of gender;
(6) Parents or other legal guardians of the child give informed consent and sign the informed consent form.

Exclusion Criteria

(1) Combined with pulmonary tuberculosis, pulmonary interstitial fibrosis, thoracic deformity, bronchiectasis and other diseases that can cause asthma or dyspnea;
(2) For patients with seasonal asthma, according to the symptoms, the annual treatment period of asthma = 2 months and other special types of asthma;
(3) Malnutrition, or serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system;
(4) Those who are known to be allergic to the components of the test drug or have definite adverse reactions;
(5) Those who do not meet the inclusion criteria, do not use drugs according to the regulations, and are unable to judge the curative effect or have incomplete data.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Asthma control rate;Pulmonary function;Peak expiratory flow(PEF);

Secondary Outcome Measures

Name	Time	Method
Single symptom score;Treatment failure rate;Number of days / week of use of palliative drugs (salbutamol aerosol);Asthma control test (ACT) score;Exhaled nitric oxide (FeNO) level;Number of wheezing symptoms / week;