Asia Pacific Journal of Clinical Trials: Nervous System Diseases最新文献

{"title":"Information for authors – Asia Pacific Journal of Clinical Trials: Nervous System Diseases","authors":"","doi":"10.4103/2542-3932.280995","DOIUrl":"https://doi.org/10.4103/2542-3932.280995","url":null,"abstract":"ing and Indexing • ADL (Asian Digital Library)","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90509224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transcranial magnetic stimulation combined with duloxetine improves attentional negativity bias in patients with depression: pilot study for a future trial","authors":"Danna Zhou, Changming Wang, Xu Chen, Lei Feng","doi":"10.4103/2542-3932.251475","DOIUrl":"https://doi.org/10.4103/2542-3932.251475","url":null,"abstract":"Background and objective: Patients with depression often have cognitive deficits in perception, attention, executive control, and decision-making. Attentional negativity bias is a prominent symptom of depression. Indeed, during processing of negative emotional stimuli, the bilateral amygdala is over-activated, while prefrontal cortical activity decreases from baseline in patients with depression. Previous studies have reported that transcranial magnetic stimulation (TMS) can increase synaptic excitability. In this study, we investigate the effects of TMS combined with duloxetine versus duloxetine alone on attentional negativity bias in patients with depression. Subjects and Methods: A multi-center, randomized, double-blind, sham-stimulation, parallel-control trial will be conducted in Beijing Anding Hospital of Capital Medical University, Beijing, China. In the trial, 406 patients with depression will be included and will be randomly divided into a study group and a control group (n = 203 patients per group). Patients in both groups will receive oral administration of 60 mg/d duloxetine for 6 successive weeks, while patients in the study and control groups will undergo simultaneous TMS or sham-stimulation, respectively. The latter interventions will be performed once daily, five times a week with a 2 day interval between the first five and the last five procedures (10 times in total). This study was approved by Hospital Ethics Committee, Beijing Anding Hospital of Capital Medical University, China (approval No. 2017-79-2017111-2) on December 20, 2017. Protocol version: 3.0. Outcome measures: The primary outcome measure is effectiveness rate of the Hamilton Rating Scale for Depression–17-Item (HAMD17) after 6 weeks of treatment. The secondary outcome measures are: complete remission rate after 6 weeks of treatment; effectiveness rate after 1, 2, and 4 weeks of treatment; changes in HAMD17, Athens Insomnia Scale, Digit Symbol Substitution Test, 16-Item Quick Inventory of Depressive Symptomatology Self-Report Scale, 7-Item Generalized Anxiety Disorder Scale, Sheehan Disability Scale, Perceived Deficits Questionnaire-Depression, Arizona Sexual Experience Scale, and Mini-International Neuropsychiatric Interview suicide scores after 1, 2, 4, and 6 weeks of treatment relative to baseline; electroencephalogram results after 2 and 6 weeks of treatment; and safety indicators and adverse events after 6 weeks of treatment. Discussion: We plan to perform a study to provide preliminary evidence for the use of TMS combined with duloxetine to improve the attentional negativity bias in patients with depression. Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-INR-17014075) on December 21, 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78357079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of aerobic exercise on adolescents with subthreshold mood symptoms: a randomized psycho-education controlled trial","authors":"Gui-yun Xu, Kangguang Lin","doi":"10.4103/2542-3932.271803","DOIUrl":"https://doi.org/10.4103/2542-3932.271803","url":null,"abstract":"Background and objective: Adolescents often suffer from mood disorders and behavioral problems. Studies have shown that aerobic exercise can improve cognitive function, relieve depression, alleviate anxiety, and improve sleep. However, there have been few randomized controlled trials (RCT) evaluating the effects of aerobic exercise on cognition and mood symptoms in adolescents with subthreshold mood symptoms. Participants and methods: This RCT will include 224 adolescents with subthreshold mood symptoms from a middle school in Guangzhou, Guangdong Province, China. Participants will be randomly allocated to exercise intervention or psycho-education controlled group (n = 112/group). Participants in the exercise intervention group will undergo aerobic exercise at an intensity of 50–70% of the maximum heart rate for 30 minutes per day, 4 days per week for 3 successive months. Participants in the psycho-education controlled group will perform activities including three sections of general psychological education (one section of group game, one section of poetry reading, and one section of singing entertainment). Protocol version: 1.0. The study protocol was approved by the Institutional Review Board of Guizhou Brain Hospital (Guangzhou Huiai Hospital) on October 26, 2016 (approval No. 2016-048). Outcome measures: The primary outcome measure of this study is changes in depressive symptoms and neurocognitive function relative to baseline at the end of 12 weeks of intervention. Secondary outcome measures are anxiety symptoms, hypomanic symptoms, and change in brain connectivity relative to baseline at the end of 12 weeks of intervention. Discussion: The effects of aerobic exercise in adolescents with subthreshold mood symptoms will be evaluated. Registeration: This study was registered with ClinicalTrials.gov (identifier: NCT03300778) on October 3, 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89056013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term follow-up of patients with multiple sclerosis treated with a cost-effective protocol from a rural medical center in India: a retrospective case series","authors":"S. Chandra, N. Chakravarthula, T. Issac, M. Philip","doi":"10.4103/2542-3932.271802","DOIUrl":"https://doi.org/10.4103/2542-3932.271802","url":null,"abstract":"Background and objectives: Multiple sclerosis affects young adults resulting in dependency after 15 years of disease. Treatments are time-consuming, expensive and do not provide full protection. The purpose of this study is to assess the therapeutic effects of rational therapy on multiple sclerosis in patients from a tertiary centre, India. Subjects and methods: This retrospective case series study included 23 patients treated with a very cost-effective protocol that was practiced for three decades in a government medical college setting in a population of 250 patients. All rational options were explained to the patients who were diagnosed with multiple sclerosis according to modified Mc Donald criteria. The patients who were willing to undergo the scheduled regime were followed up. Multiple sclerosis relapse, lesion load, and Expanded Disability Status scale (EDSS) scores were evaluated at 1 and 3 years and thereafter in a need based way. This study was approved by the Institutional Review Board, National Institute of Mental Health And Neurosciences (NIMHANS), India. Results: The mean duration of illness of 23 patients with multiple sclerosis was 6.8 ± 5.23 years and the mean remission period was 4.09 ± 3.5 years. The mean EDSS score was 3.83 ± 0.78 at onset and it was 1.15 ± 0.5 after treatment. Thirteen (22%) patients had replaces during the above period of illness but were managed well with a pulse of 5 g methyl prednisolone. Conclusion: The treatment protocol for multiple sclerosis designed for patients from an Indian rural medical center is cost-effective and has very good effects on the control of relapse and progression.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76560869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correlation between the microRNA-874-Sirtuin2-p53/nuclear factor-kappa B signaling pathway and depressive symptoms: a prospective multicenter study","authors":"Shan-Shan He, Huipeng Jiao, Qunqiang Wu, Chunhua Liao, R. Liu","doi":"10.4103/2542-3932.271801","DOIUrl":"https://doi.org/10.4103/2542-3932.271801","url":null,"abstract":"Background and objective: Impaired hippocampal neurogenesis and local inflammatory responses are considered to be important mechanisms underlying depression. Sirtuin2 can inhibit cellular oxidative stress by regulating p53/nuclear factor-κB expression, prevent high-glucose-induced vascular endothelial cell damage, and interfere with neuroinflammation and blood-brain barrier destruction. Endogenous small RNAs or microRNAs (miRs) can be involved in the development and plasticity of the nervous system, which has been associated with depression. Our preliminary studies discovered that the 3′-untranslated region of Sirtuin2 messenger RNA (mRNA) is rich in miR-874 binding sites, suggesting that miR-874 may act as an upstream regulatory molecule for Sirtuin2. Therefore, we aim to explore the association between miR-874 and depressive symptoms through clinical trials. Participants and methods: This study will be conducted as a multicenter, prospective, clinical trial, at the Department of Rehabilitation at Tangdu Hospital of the Air Force Military Medical University and at the Department of Psychosomatic Medicine at Xijing Hospital of the Air Force Military Medical University, located in Xi’an, Shaanxi Province, China. A total of 50 patients with depression and 50 healthy controls will be recruited from these two locations. All patients with depression will be newly diagnosed, characterized by experiencing their first attack, and with no history of antidepressant administration. Moreover, no drug interventions will be utilized in this trial, for either the depressed or healthy cohorts. The trial protocol was approved by the Medical Ethics Committee of Tangdu Hospital of the Fourth Military Military Medical University in Xi’an, Shaanxi Province, China on June 1, 2018 (approval No. K201806-03). Protocol version is 1.0. All participants or their legal representatives will sign informed consent forms prior to the initiation of the trial. Patient recruitment began on October 31, 2018, and is expected to end on February 28, 2021. All data analysis was completed on August 1, 2021, and the trial will be completed on September 1, 2021. Outcome measures: Primary outcome measures include the expression levels miR-874 and Sirtuin2 mRNA in the blood. The secondary outcome measures include the levels of inflammatory factors, including interleukin-1β, interleukin-6, and tumor necrosis factor α, in the blood, the Hamilton Depression Rating Scale score, the Hamilton Anxiety Rating Scale score, the Global Assessment Function score, and the incidence of overall adverse events. We will also analyze the association between miR-874 expression levels and depression. Discussion: Determining whether any association exists between the miR-874-Sirtuin2-p53/nuclear factor-κB signaling pathway and depressive symptoms will assist in the exploration of the pathogenesis of depression and may provide novel therapeutic targets for the treatment of depression. Trial registration: This stu","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75321527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of inpatient alcohol detoxification and psychotherapeutic support program: a prospective self-controlled study at a tertiary hospital in Nepal","authors":"S. Shakya, Jug Chaudhary, P. Pradhan, S. Ojha, M. Rana","doi":"10.4103/2542-3932.263670","DOIUrl":"https://doi.org/10.4103/2542-3932.263670","url":null,"abstract":"Background and objectives: Alcohol use disorder is prevalent or common and associated with a range of physical and mental sequelae. Treatment gap exists in low and middle income countries. This study aims to evaluate effectiveness of inpatient detoxification with concomitant psychotherapeutic support in terms of readiness to change and abstinence maintenance. Subjects and methods: This prospective self-controlled study included 109 patients admitted for alcohol use disorder (age: 42.5 ± 9.3 years; male: 90.8%) in a tertiary level hospital (inpatient unit at Department of Psychiatry and Mental Health at Tribhuvan University Teaching Hospital in Kathmandu). They underwent 10–14 days of inpatient detoxification and psychotherapeutic support program. Baseline assessments were done during admission, and follow-ups were done just prior to discharge, 2 weeks and 3 months after discharge. After 3 months, 63 participants were contacted through phone. Primary outcome measures were readiness for change, reflected in scores on The Stages of Change Readiness and Treatment Eagerness Scale, and status of abstinence maintenance. Ethical approval was taken from Institutional Review Board, Institute of Medicine, Tribhuvan University on December 29, 2017. Results: Results showed statistically significant reduction in “ambivalence,” and improvement in “taking steps” during discharge as well as 2 weeks after discharge in comparison to the baseline measures (P < 0.001). However, there was no significant change in “recognition.” In the 3-month follow-up, 73% of the participants were in complete abstinence; 6.3% had few drinks (up to three drinks) on a couple of occasions; and 20.6% relapsed. Conclusion: Brief inpatient treatment, incorporating pharmacological detoxification as well as psychotherapeutic support helps in enhancing readiness to change as well as maintaining alcohol-free lifestyle. Scaling up such packages to reduce treatment gap in low and middle income countries like Nepal is highly needed. Trial registration: This trial was registered in ClinicalTrials.gov (NCT03988478).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81123534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bacteriological profile of endotracheal tube aspirates in head injury patients admitted in Neurosurgical Intensive Care Unit: a cross-sectional study from a tertiary care hospital of Central Nepal","authors":"J. Das, S. Rajkumari, Shova Dangol, Rashmi Sapkota, M. Mishra","doi":"10.4103/2542-3932.263669","DOIUrl":"https://doi.org/10.4103/2542-3932.263669","url":null,"abstract":"Background and objectives: Many head injury patients have reduced consciousness, are prone to aspiration of oral secretions and likely develop pneumonia. The organisms causing such infection and their antibiotic susceptibility will vary from patient to patient. The aim of this study was to identify the common organisms which cause respiratory tract infection in Neurosurgical Intensive Care Unit, investigate their antibiotic susceptibility, and try to prepare a common antibiotic formulation which can be started empirically. We also intended to find out the antibiotic resistance of these different types of bacteria. Subjects and methods: We conducted a retrospective cross-sectional study for a period from January to June 2018 in patients who were admitted with head injury in Neurosurgical Intensive Care Unit. All those having endotracheal tubes for assisting respiration for ≥ 3 days were included in the study. Endotracheal tube aspirate was obtained on the 3rd day of admission. We recorded age, sex, Glasgow Coma Scale score at the time of admission, the respiratory pathogen isolated, and its antibiotic susceptibility and resistance as identified by bacterial culture. Statistical analysis of data was done to find out if there was any age or sex-wise distribution of the organism and to which antibiotic most of the organisms responded. This study was approved by the Institutional Review Committee of The College of Medical Sciences - Teaching Hospital, Bharatpur on November 28, 2017. Results: The types of bacteria isolated from endotracheal tube aspirate were Acinetobacter baumanii, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and Enterobacter species. Among all the antibiotics which were tested for sensitivity, Meropenem was the only one that was found to be consistently sensitive to all the above bacterial species. Conclusion: If we are encountering a respiratory tract infection in an intubated head injury patient, Meropenem is a potential antibiotic which can be the empirical drug of choice till the final culture and sensitivity are reported.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78429568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment with a halved dose of antipsychotics in patients with schizophrenia who relapse while receiving high-dose antipsychotic therapy","authors":"Ryota Ataniya","doi":"10.4103/2542-3932.263671","DOIUrl":"https://doi.org/10.4103/2542-3932.263671","url":null,"abstract":"This study proposed and discussed a new treatment for patients with schizophrenia who relapse while receiving high-dose antipsychotic therapy. There is no drug therapy available for such patients. However, antipsychotic dose reduction by half may lead to remission. The positive symptoms of schizophrenia relate to increased striatal presynaptic dopamine availability and chaotic phasic firing of dopaminergic neurons in the striatum. Dopamine levels and its function in dopamine receptors show an inverted U-shaped curve relationship, which indicates that excessively high or low dopamine levels result in decreased dopamine activation. A halved dose of antipsychotics leads to excessive increase in subcortical dopamine levels and decreased dopamine function, resulting in the improvement of positive symptoms. Furthermore, there is a negative correlation between subcortical dopamine activity and the prefrontal cortex function; therefore, reduced mesostriatal dopamine activity may lead to increased prefrontal cortex function. The recovery of prefrontal cortex function may minimize impulsive or risk behaviors. The incidence of adverse events is similar after abrupt withdrawal or tapering of antipsychotics, except for the emergence of withdrawal dyskinesia. A halved dose of antipsychotics is effective for patients with schizophrenia who relapse while receiving high-dose antipsychotic therapy. Thus, we investigated whether an abrupt change to halved dose of antipsychotics improves positive symptoms and evaluated the efficacy of such treatment.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76359044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mindfulness-based cognitive therapy for University students with depression, anxiety, and stress symptoms: a randomized controlled trial","authors":"A. Assumpção, C. Peña, C. Neufeld, M. Teodoro","doi":"10.4103/2542-3932.263668","DOIUrl":"https://doi.org/10.4103/2542-3932.263668","url":null,"abstract":"Background and objectives: Early detection and intervention of depression, anxiety and stress symptoms in college can reduce the incidence of future mental health problems, thereby achieving better academic performance and having a positive effect on future career. The effect of Mindfulness-Based Cognitive Therapy (MBCT) on stress, depression and anxiety symptoms in this population has not been fully studied. The study aims to evaluate the efficacy of MBCT in treating depression, anxiety and stress symptoms in college students. Subjects and methods: This is a randomized parallel-controlled trial. University students with depressive, anxiety and stress symptoms were randomized into MBCT group and wait-list control (control) group. The MBCT took place in a weekly meeting within 6 weeks and was delivered in groups constituted by 5–11 participants. Each meeting took 90 minutes. The primary outcomes were the Beck Depression Inventory-II, the Beck Anxiety Inventory, and the Perceived Stress Scale. The secondary outcomes were the Rosenberg Self-Esteem Scale, and the 12-Item Health Survey scores. The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil (approval No. 2.025.573) on April 20, 2017. Results: The MBCT intervention had a statistically significant reduction in depression levels at post-treatment, and the treatment gains were maintained in follow-up (P < 0.05). Besides, the intervention increased the quality of life in post-test follow-up (P < 0.05). Conclusion: The MBCT helps college students learn how to manage adverse emotional states, especially, depression. It also helps improving their quality of life. Trial registration: This trial was registered in the Brazilian Clinical Trial Registry (http://www.ensaiosclinicos.gov.br) (registration No. RBR-4mmvpc) on July 21, 2017. Funding: This study was supported by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES; to AAA).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73974537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of traditional Chinese medicine combined with western medicine for early-phase treatment of acute ischemic stroke based on the primary syndrome elements: protocol for a randomized controlled trial","authors":"Fu-sheng Liu, Xiaoli Fang, Z. Cheng, Jin Liu, Zhi Liu, Chen-Chen Sun, Lei Sun, Hui Jin","doi":"10.4103/2542-3932.257971","DOIUrl":"https://doi.org/10.4103/2542-3932.257971","url":null,"abstract":"Background and objective: Acute ischemic stroke is a major cause of disability among adults. Although traditional Chinese medicine and western medicine have been widely used for the treatment of acute ischemic stroke, their efficacy when used in combination for the treatment of acute ischemic stroke during the early phase is poorly understood. According to traditional Chinese medicine theory, the primary syndrome elements of acute ischemic stroke during the early stage include three pathogens, “wind,” “fire,” and “phlegm,” and treatments that target these primary syndrome elements contribute to recovery from the condition. We have designed a randomized controlled trial to investigate the efficacy and safety of traditional Chinese medicine combined with western medicine in the treatment of acute ischemic stroke during the early phase based on the primary syndrome elements. Subjects and methods: This prospective, single-center, assessor-blinded, randomized controlled trial will enroll 120 eligible patients with acute ischemic stroke who will receive treatment in the Department of Emergency, Dongfang Hospital of Beijing University of Chinese Medicine, China. Participants will be randomly assigned to a combined treatment group or a control group. Both groups will undergo treatment with conventional western medicine, and patients in the combined treatment group will also receive traditional Chinese medicine (i.e., oral stroke initial state decoction, intravenous Gastrodin injection, and Tanreqing injection; Xingnaojing injection will be added for patients who are unconscious). Immediately after admission, patients will undergo 3-day treatment for early-phase ischemic stroke and subsequently undergo a 2-week follow up. This study was approved by Hospital Ethics Committee, Dongfang Hospital, Beijing University of Traditional Medicine, China (approval No. JDF-IRB-2016033602) on November 2, 2016. Written informed consent will be obtained from conscious patients or the legal guardians of unconscious patients. Outcome measures: The primary outcome measures of this study are the National Institute of Health Stroke Scale score and traditional Chinese medicine stroke scale score on days 1, 3, 7, and 14 after treatment. Secondary outcome measures include National Institute of Health Stroke Scale score, Barthel index, Modified Rankin scale score, Glasgow coma scale score on days 1, 3, 7, and 14 after treatment, serum matrix metalloproteinase-9 and vascular endothelial growth factor levels on days 1 and 3 after treatment. Safety outcomes on days 1 and 3 after treatment and adverse events on days 3, 7, and 14 after treatment are also evaluated. Discussion: The results of this study will provide evidence to support the rationale for using traditional Chinese medicine combined with western medicine for the treatment of acute ischemic stroke during the early phase, and may indicate the underlying mechanism in this treatment strategy. Trial registration: This study wa","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75315475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}