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

Bronchial Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04522726
• Other study ID #: 2020LHSB022
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 84
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Weiyang Yuping Fang
Weiyang Yuping fang is a combination of the classic ancient Yuping dispersion used to prevent qi deficiency and susceptibility and Bushen Naqi granules optimized formated by Professor Shao Changrong's experience in treating chronic cough and asthma.

Locations

Country	Name	City	State
China	Longhua Hospital Affiliated Shanghai University of TCM	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual severe asthma exacerbation rate	Measured the change from Baseline of annual severe asthma exacerbation rate	up to 12 months after treatment
Secondary	Time to first severe asthma exacerbation	Record the time of the patient's first severe asthma exacerbation after treatment	up to 12 months after treatment
Secondary	Average change from baseline in pre-dose FEV1	Measured the change from Baseline of forced expiratory volume in the first second	up to 24 months
Secondary	Average change from baseline in pre-dose PEF	Measured the change from Baseline of peak expiratory flow	up to 24 months
Secondary	Average change from baseline in Asthma Control Questionnaire	Measured the change from Baseline of Asthma Control Questionnaire (5-item version) - ACQ-5 score	up to 12 months after treatment