Clinical Study on Treatment of Chronic Persistent Bronchial Asthma
1 other identifier
interventional
320
1 country
5
Brief Summary
Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2018
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedMay 25, 2023
May 1, 2023
6.6 years
July 17, 2017
May 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma control rate change
Measured the change from Baseline of asthma control rate
up to 4 weeks
Secondary Outcomes (6)
Lung function(FEV1, PEF)
Up to 4 weeks
FeNO
Up to 4 weeks
Blood routine examination
Up to 4 weeks
Liver function test
Up to 4 weeks
Cytokine levels of induced sputum
Up to 4 weeks
- +1 more secondary outcomes
Study Arms (4)
Hanxiao treatment group
EXPERIMENTAL80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
Hanxiao control group
SHAM COMPARATOR80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
Xuxiao treatment group
EXPERIMENTAL80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
Xuxiao control group
SHAM COMPARATOR80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
Interventions
Traditional Chinese Medicine
Traditional Chinese Medicine
Eligibility Criteria
You may qualify if:
- Patient diagnosed with chronic persistent asthma
- Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- Conform to the predetermined 2 TCM Syndrome Types
- Patients who have given written informed consent
You may not qualify if:
- Smoking and continuous exposure to hazardous environment
- With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
- Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- Patients who are allergic to therapeutic medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Fenglin Street Community Health Service Center
Shanghai, Shanghai Municipality, 200030, China
Kangjian Street Community Health Service Center
Shanghai, Shanghai Municipality, 200030, China
Tianping Street Community Health Service Center
Shanghai, Shanghai Municipality, 200030, China
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032, China
Fengxian District Hospital of TCM
Shanghai, Shanghai Municipality, 201400, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huiyong Zhang, Director
tcmdoctorzhang@163.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Double-blind trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2017
First Posted
July 24, 2017
Study Start
February 1, 2018
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
May 25, 2023
Record last verified: 2023-05