The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial
Abstract Background Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-07-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05444-w |
| _version_ | 1819128002978512896 |
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| author | Xiaohui Guo Meiling Xuan Huan Zheng Shumin Qin Haomeng Wu Shaogang Huang Zehuai Wen |
| author_facet | Xiaohui Guo Meiling Xuan Huan Zheng Shumin Qin Haomeng Wu Shaogang Huang Zehuai Wen |
| author_sort | Xiaohui Guo |
| collection | DOAJ |
| description | Abstract Background Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want to evaluate the efficacy and safety of HXZQ for IBS-D patients. Methods This is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week follow-up period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures. Discussion This trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment. Trial registration The trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837 . Registered on 24 October 2019. |
| first_indexed | 2024-12-22T08:20:54Z |
| format | Article |
| id | doaj.art-6d5299e45d9744cba34611ff8623a693 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-22T08:20:54Z |
| publishDate | 2021-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6d5299e45d9744cba34611ff8623a6932022-12-21T18:32:45ZengBMCTrials1745-62152021-07-012211810.1186/s13063-021-05444-wThe Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trialXiaohui Guo0Meiling Xuan1Huan Zheng2Shumin Qin3Haomeng Wu4Shaogang Huang5Zehuai Wen6Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese MedicineKey Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese MedicineDepartment of Gastroenterology, Guangdong Provincial Hospital of Chinese MedicineDepartment of Gastroenterology, Guangdong Provincial Hospital of Chinese MedicineDepartment of Gastroenterology, Guangdong Provincial Hospital of Chinese MedicineState Key Laboratory of Chinese Medicine Dampness Syndrome, Second Affiliated Hospital of Guangzhou University of Chinese MedicineKey Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese MedicineAbstract Background Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want to evaluate the efficacy and safety of HXZQ for IBS-D patients. Methods This is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week follow-up period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures. Discussion This trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment. Trial registration The trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837 . Registered on 24 October 2019.https://doi.org/10.1186/s13063-021-05444-wTraditional Chinese medicineChinese herbal formulaHuoxiang ZhengqiDiarrhea-predominant irritable bowel syndromeStudy protocol |
| spellingShingle | Xiaohui Guo Meiling Xuan Huan Zheng Shumin Qin Haomeng Wu Shaogang Huang Zehuai Wen The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial Trials Traditional Chinese medicine Chinese herbal formula Huoxiang Zhengqi Diarrhea-predominant irritable bowel syndrome Study protocol |
| title | The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial |
| title_full | The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial |
| title_fullStr | The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial |
| title_full_unstemmed | The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial |
| title_short | The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial |
| title_sort | chinese herbal formula huoxiang zhengqi for diarrhea predominant irritable bowel syndrome chairs a study protocol for a double blinded randomized controlled trial |
| topic | Traditional Chinese medicine Chinese herbal formula Huoxiang Zhengqi Diarrhea-predominant irritable bowel syndrome Study protocol |
| url | https://doi.org/10.1186/s13063-021-05444-w |
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