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

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 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bronchial Asthma
• Intervention / Treatment: Drug: Weiyang Yuping Fang

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lingna Xue, Doctor; Phone Number: 2320 +8621-64385700; Email: xuelingna02@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Longhua Hospital Affiliated Shanghai University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; 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.	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.; Other Names: Weiyang Yuping granules
Experimental: Treatment group B; 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.	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.; Other Names: Weiyang Yuping granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual severe asthma exacerbation rate	Measured the change from Baseline of annual severe asthma exacerbation rate	up to 12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Average change from baseline in pre-dose PEF	Measured the change from Baseline of peak expiratory flow	up to 24 months
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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Study Chair: Zhenhui Lu, Doctor, Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; bronchial asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2020LHSB022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No