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

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ClinicalTrials.gov Identifier: NCT04522726
Recruitment Status : Not yet recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: Weiyang Yuping Fang Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Medicines

Arms and Interventions
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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 Name: 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 Name: Weiyang Yuping granules


Outcome Measures
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Primary Outcome Measures :
  1. Annual severe asthma exacerbation rate [ Time Frame: up to 12 months after treatment ]
    Measured the change from Baseline of annual severe asthma exacerbation rate


Secondary Outcome Measures :
  1. Time to first severe asthma exacerbation [ Time Frame: up to 12 months after treatment ]
    Record the time of the patient's first severe asthma exacerbation after treatment

  2. Average change from baseline in pre-dose FEV1 [ Time Frame: up to 24 months ]
    Measured the change from Baseline of forced expiratory volume in the first second

  3. Average change from baseline in pre-dose PEF [ Time Frame: up to 24 months ]
    Measured the change from Baseline of peak expiratory flow

  4. Average change from baseline in Asthma Control Questionnaire [ Time Frame: up to 12 months after treatment ]
    Measured the change from Baseline of Asthma Control Questionnaire (5-item version) - ACQ-5 score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522726


Contacts
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Contact: Zifeng Ma, Doctor +8621-64385700 ext 1307 mzf05@126.com
Contact: Lingna Xue, Doctor +8621-64385700 ext 2320 xuelingna02@163.com

Locations
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China, Shanghai
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Study Chair: Zhenhui Lu, Doctor Shanghai University of Traditional Chinese Medicine
More Information
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04522726    
Other Study ID Numbers: 2020LHSB022
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai University of Traditional Chinese Medicine:
bronchial asthma
Traditional Chinese Medicine
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases