Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
1 other identifier
interventional
288
1 country
5
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to promote the application in community hospitals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2017
Typical duration 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
October 14, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedStudy Start
First participant enrolled
July 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 26, 2020
December 1, 2019
3.3 years
October 14, 2016
February 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma control rate
Asthma control rate will be measured during study of asthma at exacerbation stage within 44 days and symptom-free months will be measured on remission period within 12 months
up to 12 months
Secondary Outcomes (8)
Lung function(FEV1, PVC, PEF)
up to 12 months
Measurement of the fractional concentration of exhaled nitric oxide
up to 12 months
Blood routine examination
up to 12 months
Cytokine levels of serum and induced sputum
up to 12 months
Liver function test
up to 12 months
- +3 more secondary outcomes
Study Arms (8)
Hanxiao treatment group
EXPERIMENTAL36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
Hanxiao control group
PLACEBO COMPARATOR36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
Fengtanxiao treatment group
EXPERIMENTAL36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
Fengtanxiao control group
PLACEBO COMPARATOR36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture placebo and Xie Wu Capsule placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
Rexiao treatment group
EXPERIMENTAL36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
Rexiao control group
PLACEBO COMPARATOR36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
Xuxiao treatment group
EXPERIMENTAL36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule and Bu Shen Na Qi Granule oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
Xuxiao control group
PLACEBO COMPARATOR36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule placebo and Bu Shen Na Qi Granule placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
Interventions
Experience formula of famous traditional Chinese professor Yingen Wu
Experience formula of famous traditional Chinese professor Changrong Shao
Experience formula of famous traditional Chinese professor Jianhua Hu
Experience formula of famous traditional Chinese professor Xiaopu Xu
Experience formula of famous traditional Chinese professor Yingen Wu
Experience formula of famous traditional Chinese professor Changrong Shao
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
Low dose combination for treating prescription of Xie Wu Capsule
Low dose combination for treating prescription of Dan Ma Jia Tablet
Low dose combination for treating prescription of Zhi Chuan Capsule
Low dose combination for treating prescription of Bu Shen Na Qi Granule
Eligibility Criteria
You may qualify if:
- Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- Number of months without control between 1 and 3 months last year
- The course of asthma was more than 10 years and less than 30 years
- Conform to the predetermined 4 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.
- Long term inhaled corticosteroids (more than 5 years) prior to study entry
- Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- Rheumatic immune disease, diabetes, hyperthyroidism, menopause, gastroesophageal reflux, arrhythmia and other complications of the disease
- Heart, liver, kidney and other organ dysfunction
- Accompanied by other diseases of long-term use of glucocorticoids, anti allergy drugs, mental or neurological drugs or traditional Chinese Medicine
- Patients who are allergic to therapeutic medicine
- Female patients in lactation period, pregnancy or planning to get pregnant during the trial
- Patients with mental or neurological disorders
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
- STUDY CHAIR
Zhenhui Lu, Doctor
Longhua Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2016
First Posted
October 18, 2016
Study Start
July 30, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
February 26, 2020
Record last verified: 2019-12