The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
Abstract Background Post-stroke depression (PSD) is the most common psychiatric complication after a stroke. The most frequently used antidepressants are selective serotonin receptor inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), however, these exhibit a series of s...
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doaj-4ebe6012add44850b602e2226721c6d72020-11-25T00:09:37ZengBMCTrials1745-62152018-05-011911810.1186/s13063-018-2633-4The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trialAi-mei Zhao0Wen-ran Qiu1Li-jun Mao2Jun-guo Ren3Li Xu4Ming-jiang Yao5Kellie Bilinksi6Dennis Chang7Jian-xun Liu8Graduate School, Beijing University of Chinese MedicineGraduate School, Beijing University of Chinese MedicineDepartment of Neurology, Xiyuan Hospital of China Academy of Chinese Medical SciencesInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical SciencesInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical SciencesInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical SciencesNICM, Western Sydney UniversityNICM, Western Sydney UniversityInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical SciencesAbstract Background Post-stroke depression (PSD) is the most common psychiatric complication after a stroke. The most frequently used antidepressants are selective serotonin receptor inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), however, these exhibit a series of side effects. Traditional Chinese medicine has been used to treat PSD with few side effects. The aim of this study is to evaluate the efficacy and safety of Jiedu Tongluo granules for treating PSD with qi deficiency and blood stasis syndrome. Methods The planned study is a double-blind, randomized, placebo-controlled pilot trial. Eighty participants will be randomly assigned to receive either treatment or placebo. The treatment group will receive Jiedu Tongluo granules (JDTLG) with conventional treatment, and the placebo group will receive placebo with conventional treatment for 8 weeks. The primary outcome is the effectiveness of JDTLG on depression after 8 weeks treatment, which is defined as a decrease of 50% or more in 17-item Hamilton Depression Scale (HAMD-17) score or clinical recovery (score < 7). Secondary outcomes are improvement in neurological function, degree of independence, activities of daily living, and TCM syndrome at each visit, which will be measured with National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Barthel Index (BI) and TCM scale, respectively. Interleukin (IL)-6, IL-8, and small-molecule metabolites will be monitored to explore the mechanism of action of JDTLG on PSD. Safety measures include vital signs, results of electrocardiography, laboratory index (full blood count, kidney and liver function tests) and adverse events. Discussion The purpose of this trial is to evaluate the therapeutic effects and safety of JDTLG in individuals with PSD with concomitant qi deficiency and blood stasis syndrome. If successful, the outcome of this trial will provide a viable treatment option for PSD patients. Trial registration ClinicalTrials.gov ID: NCT03147053. Registered on 27 April 2017. http://link.springer.com/article/10.1186/s13063-018-2633-4Jiedu Tongluo granulesPost-stroke depressionRandomized controlled trialChinese herbal medicineQi deficiency and blood stasis syndrome |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Ai-mei Zhao Wen-ran Qiu Li-jun Mao Jun-guo Ren Li Xu Ming-jiang Yao Kellie Bilinksi Dennis Chang Jian-xun Liu |
spellingShingle |
Ai-mei Zhao Wen-ran Qiu Li-jun Mao Jun-guo Ren Li Xu Ming-jiang Yao Kellie Bilinksi Dennis Chang Jian-xun Liu The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial Trials Jiedu Tongluo granules Post-stroke depression Randomized controlled trial Chinese herbal medicine Qi deficiency and blood stasis syndrome |
author_facet |
Ai-mei Zhao Wen-ran Qiu Li-jun Mao Jun-guo Ren Li Xu Ming-jiang Yao Kellie Bilinksi Dennis Chang Jian-xun Liu |
author_sort |
Ai-mei Zhao |
title |
The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial |
title_short |
The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial |
title_full |
The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial |
title_fullStr |
The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial |
title_full_unstemmed |
The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial |
title_sort |
efficacy and safety of jiedu tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-05-01 |
description |
Abstract Background Post-stroke depression (PSD) is the most common psychiatric complication after a stroke. The most frequently used antidepressants are selective serotonin receptor inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), however, these exhibit a series of side effects. Traditional Chinese medicine has been used to treat PSD with few side effects. The aim of this study is to evaluate the efficacy and safety of Jiedu Tongluo granules for treating PSD with qi deficiency and blood stasis syndrome. Methods The planned study is a double-blind, randomized, placebo-controlled pilot trial. Eighty participants will be randomly assigned to receive either treatment or placebo. The treatment group will receive Jiedu Tongluo granules (JDTLG) with conventional treatment, and the placebo group will receive placebo with conventional treatment for 8 weeks. The primary outcome is the effectiveness of JDTLG on depression after 8 weeks treatment, which is defined as a decrease of 50% or more in 17-item Hamilton Depression Scale (HAMD-17) score or clinical recovery (score < 7). Secondary outcomes are improvement in neurological function, degree of independence, activities of daily living, and TCM syndrome at each visit, which will be measured with National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Barthel Index (BI) and TCM scale, respectively. Interleukin (IL)-6, IL-8, and small-molecule metabolites will be monitored to explore the mechanism of action of JDTLG on PSD. Safety measures include vital signs, results of electrocardiography, laboratory index (full blood count, kidney and liver function tests) and adverse events. Discussion The purpose of this trial is to evaluate the therapeutic effects and safety of JDTLG in individuals with PSD with concomitant qi deficiency and blood stasis syndrome. If successful, the outcome of this trial will provide a viable treatment option for PSD patients. Trial registration ClinicalTrials.gov ID: NCT03147053. Registered on 27 April 2017. |
topic |
Jiedu Tongluo granules Post-stroke depression Randomized controlled trial Chinese herbal medicine Qi deficiency and blood stasis syndrome |
url |
http://link.springer.com/article/10.1186/s13063-018-2633-4 |
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