Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial
Abstract Background Sanfu herbal patch (SHP) is widely used in the prevention and treatment of bronchial asthma in China, but its efficacy and mechanism of action are not completely clear. This trial aims to determine the efficacy of SHP and the underlying mechanism. Methods/design We will conduct a...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06990-7 |
| _version_ | 1797977241209012224 |
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| author | Danghan Xu Jialing Li Anqi Di Peidan Yang Xiaoyan Xie Yiming Xu Jun He |
| author_facet | Danghan Xu Jialing Li Anqi Di Peidan Yang Xiaoyan Xie Yiming Xu Jun He |
| author_sort | Danghan Xu |
| collection | DOAJ |
| description | Abstract Background Sanfu herbal patch (SHP) is widely used in the prevention and treatment of bronchial asthma in China, but its efficacy and mechanism of action are not completely clear. This trial aims to determine the efficacy of SHP and the underlying mechanism. Methods/design We will conduct a multi-centre parallel randomised controlled trial consisting of 72 participants with bronchial asthma recruited and randomly allocated at a ratio of 1:1 into two groups. The patients in one group will receive three courses of SHP treatment, and the patients in the other group will receive placebo treatment, with 24 weeks of follow-up evaluation for both groups. The primary outcome, i.e. forced expiratory volume in the first second (FEV1), which refers to the change in FEV1 from the beginning of the baseline to the end of 3 treatment sessions (TSs), will be assessed and compared via Student’s t test or the Mann–Whitney U test. Other outcomes will include questionnaire surveys and laboratory indicators. Detailed and complete statistical analyses in a double-blinded fashion will be provided for evaluating this trial. Discussion The data we obtain will be examined based on the above statistical analysis, which will help to reduce the risk of external reporting bias and data-driven results. Trial registration Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), ChiCTR1900024616. Registered on 19 July 2019. |
| first_indexed | 2024-04-11T05:03:49Z |
| format | Article |
| id | doaj.art-16caf35c31594edabde98892480c2ab6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T05:03:49Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-16caf35c31594edabde98892480c2ab62022-12-25T12:28:18ZengBMCTrials1745-62152022-12-0123111010.1186/s13063-022-06990-7Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trialDanghan Xu0Jialing Li1Anqi Di2Peidan Yang3Xiaoyan Xie4Yiming Xu5Jun He6The First Affiliated Hospital of Guangzhou University of Chinese MedicineThe First Affiliated Hospital of Guangzhou University of Chinese MedicineThe First Affiliated Hospital of Guangzhou University of Chinese MedicineThe First Affiliated Hospital of Guangzhou University of Chinese MedicineThe Second Clinical College, Guangzhou University of Chinese MedicineSchool of Basic Medicine, Guangzhou Medical UniversityThe First Affiliated Hospital of Guangzhou University of Chinese MedicineAbstract Background Sanfu herbal patch (SHP) is widely used in the prevention and treatment of bronchial asthma in China, but its efficacy and mechanism of action are not completely clear. This trial aims to determine the efficacy of SHP and the underlying mechanism. Methods/design We will conduct a multi-centre parallel randomised controlled trial consisting of 72 participants with bronchial asthma recruited and randomly allocated at a ratio of 1:1 into two groups. The patients in one group will receive three courses of SHP treatment, and the patients in the other group will receive placebo treatment, with 24 weeks of follow-up evaluation for both groups. The primary outcome, i.e. forced expiratory volume in the first second (FEV1), which refers to the change in FEV1 from the beginning of the baseline to the end of 3 treatment sessions (TSs), will be assessed and compared via Student’s t test or the Mann–Whitney U test. Other outcomes will include questionnaire surveys and laboratory indicators. Detailed and complete statistical analyses in a double-blinded fashion will be provided for evaluating this trial. Discussion The data we obtain will be examined based on the above statistical analysis, which will help to reduce the risk of external reporting bias and data-driven results. Trial registration Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), ChiCTR1900024616. Registered on 19 July 2019.https://doi.org/10.1186/s13063-022-06990-7Bronchial asthmaSanfu herbal patchStatistical analysis plan |
| spellingShingle | Danghan Xu Jialing Li Anqi Di Peidan Yang Xiaoyan Xie Yiming Xu Jun He Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial Trials Bronchial asthma Sanfu herbal patch Statistical analysis plan |
| title | Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial |
| title_full | Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial |
| title_fullStr | Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial |
| title_full_unstemmed | Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial |
| title_short | Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial |
| title_sort | sanfu herbal patch applied at acupoints in patients with bronchial asthma statistical analysis plan for a randomised controlled trial |
| topic | Bronchial asthma Sanfu herbal patch Statistical analysis plan |
| url | https://doi.org/10.1186/s13063-022-06990-7 |
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