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

Category Primary study
Registry of TrialsITMCTR
Year 2022
INTERVENTION: Control group:Xiaoer Zhixiao Pingchuan Granule (simulant) + Montelukast Sodium Granule;Test group:Xiaoer Zhixiao Pingchuan Granule + montelukast Naju granule (simulant)Granule; CONDITION: bronchial asthma PRIMARY OUTCOME: Asthma control rate;Pulmonary function;Peak expiratory flow(PEF); SECONDARY OUTCOME: 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; 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 gen
Epistemonikos ID: 2f83e82f03535c6b0aa3d003998b63cde2c25485
First added on: Aug 26, 2024