A Clinical Study on the Prevention of Mild to Moderate Intermittent Asthma With Chinese Medicine Weiyang Yuping Fang

Phase 2

• Conditions: Bronchial Asthma
• Interventions: Drug: Weiyang Yuping Fang

• Registration Number: NCT04522726
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

Clinical exploring study of Weiyang Yuping Decoction in preventing acute attacks of mild to moderate intermittent asthma Based on the theory of "Preventing disease from exacerbating" in Chinese medicine.

Detailed Description

Based on the preliminary clinical and basic research, this project intends to highly optimize and integrate the TCM treatment of disease theory with the current methods to form two preventive treatment plans, one treatment group was given Weiyang Yupingfang Granules orally for 1 month on the "Sanfu"days and on the "Sanjiu" days each year for a total of 2 months one year; the other treatment group was given Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months one year.; Comparing the effect of prevention and treatment of mild to moderate intermittent asthma exacerbations of the two prevention methods , provides new ideas for the prevention and treatment of bronchial asthma in the future, and further improves bronchial The level of prevention and treatment of asthma.

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Study Start: 2020-10-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Diagnosis of asthma according to GINA criteria with a documented history of at least 3 years prior to Visit 1
• Patients have asthma exacerbations every year
• Meet the diagnostic criteria for mild to moderate asthma
• Able to measure lung ventilation function according to ATS (American Thoracic Society) standards
• Patients who have given written informed consent

Exclusion Criteria

• Medical history of life-threatening asthma including intubation and intensive care unit admission
• Any significant disease or disorder (e.g., cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
• Pregnancy, breast-feeding or planned pregnancy during the study.
• Participation in another clinical study or took other research drugs during the last 30 days prior to Visit 1
• Known or suspected hypersensitivity to study drugs or excipient
• Suspected poor capability, as judged by the investigator, of following instructions of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	Weiyang Yuping Fang	Treatment group A received Weiyang Yupingfang Granules orally for 1 month on the "Sanfu" days and on the"Sanjiu"days each year for a total of 2 months a year.
Treatment group B	Weiyang Yuping Fang	Treatment group A received Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months a year.

Primary Outcome Measures

Name	Time	Method
Annual severe asthma exacerbation rate	up to 12 months after treatment	Measured the change from Baseline of annual severe asthma exacerbation rate

Secondary Outcome Measures

Name	Time	Method
Time to first severe asthma exacerbation	up to 12 months after treatment	Record the time of the patient's first severe asthma exacerbation after treatment
Average change from baseline in Asthma Control Questionnaire	up to 12 months after treatment	Measured the change from Baseline of Asthma Control Questionnaire (5-item version) - ACQ-5 score
Average change from baseline in pre-dose FEV1	up to 24 months	Measured the change from Baseline of forced expiratory volume in the first second
Average change from baseline in pre-dose PEF	up to 24 months	Measured the change from Baseline of peak expiratory flow

Trial Locations

Locations (1)

Longhua Hospital Affiliated Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China