Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial
Abstract Background Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiao...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05909-y |
| _version_ | 1818941682767364096 |
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| author | Zhe Xue Zhen Huang Shu-li Cheng Xi-hong Wang Xuan Zhou Qing-yu Ma Jia-xu Chen |
| author_facet | Zhe Xue Zhen Huang Shu-li Cheng Xi-hong Wang Xuan Zhou Qing-yu Ma Jia-xu Chen |
| author_sort | Zhe Xue |
| collection | DOAJ |
| description | Abstract Background Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients. Methods This study is a multi-centre, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants are assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline (before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks. Discussion The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency. Trial registration ClinicalTrials.gov ISRCTN12746343. Registered on September 25, 2020. |
| first_indexed | 2024-12-20T06:59:25Z |
| format | Article |
| id | doaj.art-9c2e203cc67f41909c67ed0f01570ccc |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T06:59:25Z |
| publishDate | 2022-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9c2e203cc67f41909c67ed0f01570ccc2022-12-21T19:49:14ZengBMCTrials1745-62152022-01-0123111210.1186/s13063-021-05909-yEfficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trialZhe Xue0Zhen Huang1Shu-li Cheng2Xi-hong Wang3Xuan Zhou4Qing-yu Ma5Jia-xu Chen6School of Traditional Chinese Medicine, Beijing University of Chinese MedicineSchool of Traditional Chinese Medicine, Beijing University of Chinese MedicineSchool of Traditional Chinese Medicine, Beijing University of Chinese MedicineSchool of Traditional Chinese Medicine, Beijing University of Chinese MedicineGuangzhou Key Laboratory of Formula-Pattern of Traditional Chinese Medicine, School of Traditional Chinese Medicine, Jinan UniversityGuangzhou Key Laboratory of Formula-Pattern of Traditional Chinese Medicine, School of Traditional Chinese Medicine, Jinan UniversitySchool of Traditional Chinese Medicine, Beijing University of Chinese MedicineAbstract Background Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients. Methods This study is a multi-centre, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants are assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline (before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks. Discussion The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency. Trial registration ClinicalTrials.gov ISRCTN12746343. Registered on September 25, 2020.https://doi.org/10.1186/s13063-021-05909-yTraditional Chinese MedicineDepressionRandomized controlled trial |
| spellingShingle | Zhe Xue Zhen Huang Shu-li Cheng Xi-hong Wang Xuan Zhou Qing-yu Ma Jia-xu Chen Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial Trials Traditional Chinese Medicine Depression Randomized controlled trial |
| title | Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial |
| title_full | Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial |
| title_fullStr | Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial |
| title_full_unstemmed | Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial |
| title_short | Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial |
| title_sort | efficacy and safety of xiaoyao pills for mild to moderate depression study protocol for a randomized controlled trial |
| topic | Traditional Chinese Medicine Depression Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-021-05909-y |
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