Back to results

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

Primary Purpose

Bronchial Asthma

Status

Enrolling by invitation

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Weiyang Yuping Fang

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring bronchial asthma, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Longhua Hospital Affiliated Shanghai University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment group A

Treatment group B

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Annual severe asthma exacerbation rate

Measured the change from Baseline of annual severe asthma exacerbation rate

Secondary Outcome Measures

Time to first severe asthma exacerbation

Record the time of the patient's first severe asthma exacerbation after treatment

Average change from baseline in pre-dose FEV1

Measured the change from Baseline of forced expiratory volume in the first second

Average change from baseline in pre-dose PEF

Measured the change from Baseline of peak expiratory flow

Average change from baseline in Asthma Control Questionnaire

Measured the change from Baseline of Asthma Control Questionnaire (5-item version) - ACQ-5 score

Full Information

NCT ID

NCT04522726

First Posted

August 19, 2020

Last Updated

May 24, 2023

Sponsor

Shanghai University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04522726

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchial Asthma

Keywords

bronchial asthma, Traditional Chinese Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group A

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment group B

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Weiyang Yuping Fang

Other Intervention Name(s)

Weiyang Yuping granules

Intervention Description

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.

Primary Outcome Measure Information:

Title

Annual severe asthma exacerbation rate

Description

Measured the change from Baseline of annual severe asthma exacerbation rate

Time Frame

up to 12 months after treatment

Secondary Outcome Measure Information:

Title

Time to first severe asthma exacerbation

Description

Record the time of the patient's first severe asthma exacerbation after treatment

Time Frame

up to 12 months after treatment

Title

Average change from baseline in pre-dose FEV1

Description

Measured the change from Baseline of forced expiratory volume in the first second

Time Frame

up to 24 months

Title

Average change from baseline in pre-dose PEF

Description

Measured the change from Baseline of peak expiratory flow

Time Frame

up to 24 months

Title

Average change from baseline in Asthma Control Questionnaire

Description

Measured the change from Baseline of Asthma Control Questionnaire (5-item version) - ACQ-5 score

Time Frame

up to 12 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhenhui Lu, Doctor

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Longhua Hospital Affiliated Shanghai University of TCM

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs