Yi-Qi-Pin-Chuan granules: a Chinese medicine for treatment of acute asthma
| ISRCTN | ISRCTN61674768 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61674768 |
| Protocol serial number | N/A |
| Sponsor | West China Hospital at Sichuan University (China) |
| Funders | Ministry of Education of the People's Republic of China (China) - Doctoral Fund (ref: 20070610155), National Natural Science Foundation of China (China) (ref: 30971326 and 30901907) |
- 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
Scientific
Pneumology Group
Department of Integrated Traditional Chinese and Western Medicine
Sichuan University
Chengdu
610041
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Yi-Qi-Pin-Chuan granules |
| Primary outcome measure(s) |
The number of patients with use of systemic steroids and steroid dose, evaluated at days 4 and 8 |
| Key secondary outcome measure(s) |
1. The number of patients with hospital admissions, evaluated at days 4 and 8 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
610041
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/07/2018: Publication reference added.
