Condition category
Respiratory
Date applied
27/06/2010
Date assigned
29/07/2010
Last edited
29/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gang Wang

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Chinese herbs in treatment of acute asthma: a multicentre randomised, double-blind, placebo-controlled trial

Acronym

Study hypothesis

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

Medical Ethics Committee of West China Hospital at Sichuan University approved on the 25th May 2010

Study design

Multicentre randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Yi-Qi-Pin-Chuan granules

Primary outcome measures

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 trial start date

15/07/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant 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 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

Recruitment start date

15/07/2010

Recruitment end date

31/12/2010

Locations

Countries of recruitment

China

Trial participating centre

Pneumology Group
Chengdu
610041
China

Sponsor information

Organisation

West China Hospital at Sichuan University (China)

Sponsor details

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

Sponsor type

University/education

Website

http://www.scu.edu.cn/en/index.htm

Funders

Funder type

Government

Funder name

Ministry of Education of China (China) - Doctoral Fund (ref: 20070610155)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Natural Science Foundation of China (China) (ref: 30971326 and 30901907)

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

China

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes