Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
NCT ID: NCT02937207
Last Updated: 2020-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
288 participants
INTERVENTIONAL
2017-07-30
2021-12-31
Brief Summary
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Detailed Description
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In this study, the investigators recruited patients with asthma exacerbation and remission stage, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program.Participants will undergo a physical examination, lung function, blood and sputum collection.
Exacerbation group belongs to cold type of asthma patients will take Ke Chuan Liu Wei Mixture, wind phlegm type of asthma patients will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule，and hot type of asthma patients will take Dan Ma Jia Tablet for 14 days treatment, while the 3 control groups were given 3 corresponding placebo treatment for a total of 14 days.
Remission phase of Yang deficiency patients in treatment group will take Zhi Chuan Capsule and Bu Shen Na Qi Granule, and in control group received a placebo treatment for a total of 60 days.
Study visits will occur for 7 days of exacerbation group and 1 year for remission group. Questionnaires to assess asthma control will be completed during study of asthma at exacerbation stage within 44 days and on remission period within 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hanxiao treatment group
36 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.
Ke Chuan Liu Wei Mixture
Experience formula of famous traditional Chinese professor Yingen Wu
Hanxiao control group
36 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.
Ke Chuan Liu Wei Mixture placebo
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
Fengtanxiao treatment group
36 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.
Chuan Xiong Ping Chuan Mixture
Experience formula of famous traditional Chinese professor Changrong Shao
Xie Wu Capsule
Experience formula of famous traditional Chinese professor Jianhua Hu
Fengtanxiao control group
36 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.
Chuan Xiong Ping Chuan Mixture placebo
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
Xie Wu Capsule placebo
Low dose combination for treating prescription of Xie Wu Capsule
Rexiao treatment group
36 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.
Dan Ma Jia Tablet
Experience formula of famous traditional Chinese professor Xiaopu Xu
Rexiao control group
36 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.
Dan Ma Jia Tablet placebo
Low dose combination for treating prescription of Dan Ma Jia Tablet
Xuxiao treatment group
36 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.
Zhi Chuan Capsule
Experience formula of famous traditional Chinese professor Yingen Wu
Bu Shen Na Qi Granule
Experience formula of famous traditional Chinese professor Changrong Shao
Xuxiao control group
36 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.
Zhi Chuan Capsule placebo
Low dose combination for treating prescription of Zhi Chuan Capsule
Bu Shen Na Qi Granule placebo
Low dose combination for treating prescription of Bu Shen Na Qi Granule
Interventions
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Ke Chuan Liu Wei Mixture
Experience formula of famous traditional Chinese professor Yingen Wu
Chuan Xiong Ping Chuan Mixture
Experience formula of famous traditional Chinese professor Changrong Shao
Xie Wu Capsule
Experience formula of famous traditional Chinese professor Jianhua Hu
Dan Ma Jia Tablet
Experience formula of famous traditional Chinese professor Xiaopu Xu
Zhi Chuan Capsule
Experience formula of famous traditional Chinese professor Yingen Wu
Bu Shen Na Qi Granule
Experience formula of famous traditional Chinese professor Changrong Shao
Ke Chuan Liu Wei Mixture placebo
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
Chuan Xiong Ping Chuan Mixture placebo
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
Xie Wu Capsule placebo
Low dose combination for treating prescription of Xie Wu Capsule
Dan Ma Jia Tablet placebo
Low dose combination for treating prescription of Dan Ma Jia Tablet
Zhi Chuan Capsule placebo
Low dose combination for treating prescription of Zhi Chuan Capsule
Bu Shen Na Qi Granule placebo
Low dose combination for treating prescription of Bu Shen Na Qi Granule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Zhenhui Lu, Doctor
Role: STUDY_CHAIR
Longhua Hospital
Locations
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Fenglin Street Community Health Service Center
Shanghai, Shanghai Municipality, China
Kangjian Street Community Health Service Center
Shanghai, Shanghai Municipality, China
Tianping Street Community Health Service Center
Shanghai, Shanghai Municipality, China
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, China
Fengxian District Hospital of TCM
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LH20161013
Identifier Type: -
Identifier Source: org_study_id
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