Yi-Qi-Pin-Chuan granules: a Chinese medicine for treatment of acute asthma

ISRCTN	ISRCTN61674768
DOI	https://doi.org/10.1186/ISRCTN61674768
Secondary identifying numbers	N/A

Submission date: 27/06/2010
Registration date: 29/07/2010
Last edited: 02/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gang Wang
Scientific

Pneumology Group
Department of Integrated Traditional Chinese and Western Medicine
Sichuan University
Chengdu
610041
China

Study information

Study design	Multicentre randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Chinese herbs in treatment of acute asthma: a multicentre randomised, double-blind, placebo-controlled trial
Study objectives	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.
Ethics approval(s)	Medical Ethics Committee of West China Hospital at Sichuan University, 25/05/2010
Health condition(s) or problem(s) studied	Mild to moderate asthma in acute exacerbation
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Yi-Qi-Pin-Chuan granules
Primary outcome measure	The number of patients with use of systemic steroids and steroid dose, evaluated at days 4 and 8
Secondary outcome measures	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
Overall study start date	15/07/2010
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	240
Key inclusion criteria	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
Key exclusion criteria	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 breastfeeding 10. The inability to understand and complete this study 11. Peptic ulcer or gastrointestinal haemorrhage 12. Intolerance to beta-2-agonists or steroids
Date of first enrolment	15/07/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

China

Study participating centre

Sichuan University

Chengdu
610041
China

Sponsor information

West China Hospital at Sichuan University (China)
University/education

c/o Gang Wang
Pneumology Group
Department of Integrated Traditional Chinese and Western Medicine
Chengdu
610041
China

Website	http://www.scu.edu.cn/en/index.htm
"ROR"	https://ror.org/007mrxy13

Funders

Funder type

Government

Ministry of Education of the People's Republic of China (China) - Doctoral Fund (ref: 20070610155)
Government organisation / National government

Alternative name(s): 中华人民共和国教育部, Министерство образования Китайской Народной Республики, 中華人民共和国教育部, Bildungsministerium der Volksrepublik China, Ministry of Education of China, Ministry of Education, The People's Republic of China, Ministry of Education of the Central People's Government, State Education Commission, MOE
Location: China

National Natural Science Foundation of China (China) (ref: 30971326 and 30901907)
Government organisation / National government

Alternative name(s): Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Location: China

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2018		Yes	No

Editorial Notes

02/07/2018: Publication reference added.