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

NCT04522726 | Unknown Phase 2 DMC

• 1 other identifier: 2020LHSB022
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma

Keywords

bronchial asthma; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Annual severe asthma exacerbation rate

  Measured the change from Baseline of annual severe asthma exacerbation rate

  up to 12 months after treatment

Secondary Outcomes (4)

• Time to first severe asthma exacerbation

  up to 12 months after treatment

• Average change from baseline in pre-dose FEV1

  up to 24 months

• Average change from baseline in pre-dose PEF

  up to 24 months

• Average change from baseline in Asthma Control Questionnaire

  up to 12 months after treatment

Study Arms (2)

Treatment group A

EXPERIMENTAL

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

Treatment group B

EXPERIMENTAL

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

Interventions

Weiyang Yuping Fang DRUG

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.

Also known as: Weiyang Yuping granules

Treatment group A; Treatment group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Longhua Hospital Affiliated Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Zhenhui Lu, Doctor

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One 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 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)