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ISRCTN
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ISRCTN61674768
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ClinicalTrials.gov identifier
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Public title
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Yi-Qi-Pin-Chuan granules: a Chinese medicine for treatment of acute asthma
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Scientific title
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Chinese herbs in treatment of acute asthma: a multicentre randomised, double-blind, placebo-controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Traditional Chinese medicine has been widely used in treatment of acute asthma in China, but it is based on clinical experience rather than the evidence of randomised controlled trials. Since the introduction of traditional Chinese medicine to the world, there have been many debates regarding a role for herbal medicines in the therapy of asthma.
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Lay summary
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Ethics approval
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Medical Ethics Committee of West China Hospital at Sichuan University approved on the 25th May 2010
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Study design
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Multicentre randomised double-blind placebo-controlled trial
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Countries of recruitment
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China
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Disease/condition/study domain
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Mild to moderate asthma in acute exacerbation
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Participants - inclusion criteria
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1. Mild to moderate asthma in acute exacerbation
2. Male and female patients between 15 and 75 years
3. Within 72 hours of onset of acute asthma
4. Ability to provide written informed consent
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Participants - exclusion criteria
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1. Use of systemic steroids or immunosuppressive agents within one month before recruitment, or history of life-threatening asthma requiring treatment with intubation and mechanical ventilation
2. Maintenance therapy with symbicort, or rescue therapy with formoterol or anticholinergic agents
3. Allergies to any components Yi-Qi-Pin-Chuan granule, as Chinese medicine
4. Current alcoholism or drug abuse
5. Lung diseases other asthma
6. Severe diseases of cardiovascular, hepatic, renal, central nervous system, haematopoietic system cancer
7. Significant medical illness (other than asthma) that is not stable
8. History of respiratory tract infection within the previous 6 weeks
9. Pregnancy or breast-feeding
10. The inability to understand and complete this study
11. Peptic ulcer or gastrointestinal haemorrhage
12. Intolerance to beta-2-agonists or steroids
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Anticipated start date
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15/07/2010
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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240
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Interventions
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Chinese herbs arm: Chinese herbs and beta-2-agonists (salbutamol), systemic steroids (0.5 - 1 mg/Kg) if necessary.
Placebo arm: placebo and beta-2-agonists (salbutamol), systemic steroids (0.5 - 1 mg/Kg) if necessary.
Period of treatment: 7 days - there is no follow-up period.
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Primary outcome measure(s)
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The number of patients with use of systemic steroids and steroid dose, evaluated at days 4 and 8
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Secondary outcome measure(s)
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1. The number of patients with hospital admissions, evaluated at days 4 and 8
2. The number of puffs of beta agonists (salbutamol), recorded in asthma diary by the patient
3. Lung functions (PEF), assessed at hours 0, 2, 4, 6, 8, 10, 12 after recruitment, and in morning and evening every day during 7 days of treatment
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Sources of funding
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1. Ministry of Education of China (China) - Doctoral Fund (ref: 20070610155)
2. National Natural Science Foundation of China (China) (ref: 30971326 and 30901907)
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Trial website
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Publications
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Contact name
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Prof
Gang
Wang
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Address
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Pneumology Group
Department of Integrated Traditional Chinese and Western Medicine
Sichuan University
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City/town
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Chengdu
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Zip/Postcode
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610041
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Country
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China
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Sponsor
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West China Hospital at Sichuan University (China)
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Address
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c/o Gang Wang
Pneumology Group
Department of Integrated Traditional Chinese and Western Medicine
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City/town
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Chengdu
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Zip/Postcode
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610041
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Country
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China
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Sponsor website:
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http://www.scu.edu.cn/en/index.htm
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Date applied
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27/06/2010
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Last edited
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29/07/2010
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Date ISRCTN assigned
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29/07/2010
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