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Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial.

ABSTRACT: Ischemic stroke (IS) is characterized by high morbidity and high mortality. The integration of Traditional Chinese medicine (TCM) and western medicine has shown promising benefits in relieving symptoms, promoting neurological recovery, and improving the quality of life of patients with IS. In TCM, Qi-deficiency along with blood-stasis (QDBS) syndrome is one of the common types of IS that is treated by invigorating Qi and activating blood circulation. In TCM theory, improving the corresponding degree of prescription-syndrome correlation (PSC) is helpful to improve clinical efficacy. In this study, we intend to use similar prescriptions that invigorate Qi and activate blood circulation: Buyang Huanwu granules (BHG), Naoxintong capsules (NXTC), and Yangyin Tongnao granules (YTG). The goal is to evaluate their level of PSC inpatients with IS with QDBS syndrome and find relevant biomarkers to provide an objective basis for precise treatment of TCM and improve the clinical therapeutic effects. A multicenter, randomized, double-blinded, and placebo-controlled intervention trial will be conducted in IS patients with QDBS syndrome, followed by an add-on of Chinese patent medicine. A total of 160 subjects will be randomly assigned to the BHG, NXTC, YTG, and placebo groups in a 1:2:1:1 allocation ratio. All subjects will undergo 28 days of treatment and then followed for another 180 days. The primary outcome is the changes in the National Institutes of Health Stroke Scale score after 28 days of medication. The secondary outcomes include the modified Rankin scale score, activity of daily living scale score, and TCM symptom score. Data will be analyzed in accordance with a predefined statistical analysis plan. Ethical approval of this trial has been granted by the Research Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (ID: 2017-Y-004-02). Written informed consent of patients will be required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR1800015189), and the results will be disseminated to the public through peer-reviewed journals and academic conferences.

SUBMITTER: Wang Y

PROVIDER: S-EPMC7311665 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial.

Wang Yu Y Zhang Ling L Pan Yuan-Jiang YJ Fu Wei W Huang Shu-Wei SW Xu Bin B Dou Li-Ping LP Hou Qun Q Li Chang C Yu Li L Zhou Hui-Fen HF Yang Jie-Hong JH Wan Hai-Tong HT

Frontiers in pharmacology 20200617

Ischemic stroke (IS) is characterized by high morbidity and high mortality. The integration of Traditional Chinese medicine (TCM) and western medicine has shown promising benefits in relieving symptoms, promoting neurological recovery, and improving the quality of life of patients with IS. In TCM, Qi-deficiency along with blood-stasis (QDBS) syndrome is one of the common types of IS that is treated by invigorating Qi and activating blood circulation. In TCM theory, improving the co ...[more]

PMID: 32625091

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Project description:Background: IgA nephropathy (IgAN) is a common primary glomerular disease, and supplementing qi dispelling wind and activating blood is commonly used as a treatment method in Chinese medicine. However, the existing studies have small sample sizes. This study aimed to use a meta-analysis to explore the clinical efficacy of this method and to systematically introduce this effective treatment. Methods: We searched for randomized controlled trial studies on supplementing qi dispelling wind and activating blood circulation methods for IgAN indexed in the China National Knowledge Infrastructure, Wanfang Data, Chongqing VIP, SinoMed, PubMed, EMBASE, and Web of Science databases, which were interrogated from database inception to January 2022. Combining the inclusion and exclusion criteria to screen the literature, we included a total of 15 eligible studies; the quality of the included studies was evaluated using the risk of bias assessment tool of the Cochrane System Revies Manual 5.4. The outcome indexes were extracted, and a meta-analysis was performed using Review Manager 5.4 software. Results: Fifteen articles were included in this review. A meta-analysis of the results led to the conclusion that supplementing qi dispelling wind and activating blood circulation prescription has beneficial effects on the total effective rate [odds ratios = 3.95, 95% confidence interval (CI) 2.76–5.67], and can reduce 24-hour urinary protein quantity (mean deviation = −0.35, 95% CI −0.54 to −0.16) and serum creatinine (mean deviation = −15.41,95% CI −28.39 to −2.44) without impact normal level of alanine transaminase, hemoglobin, and serum albumin. Conclusions: Supplementing qi dispelling wind and activating blood can significantly improve renal function and reduce 24-hour urinary protein quantity levels in patients with IgAN compared to the use of non-Chinese medicine treatment. This finding provides a rationale for using this method in the clinical treatment of IgAN.

Project description:BackgroundPost-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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov ID: NCT03147053 . Registered on 27 April 2017.

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Dataset Information

Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial.

Publications

Investigation of Invigorating <i>Qi</i> and Activating Blood Circulation Prescriptions in Treating <i>Qi</i> Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial.

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