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.
Highlights
Stroke is the second leading cause of death and a leading cause of disability worldwide (Feigin et al, 2014; Norberto et al, 2017)
We will evaluate the level of PSC for Buyang Huanwu granules (BHG), Naoxintong capsules (NXTC), and Yangyin Tongnao granules (YTG) in Ischemic stroke (IS) with Qi-deficiency with blood-stasis (QDBS) syndrome, identify helpful clinical biomarkers that are related to IS with QDBS syndrome, and provide an objective basis for precise Traditional Chinese medicine (TCM) treatment that can improve clinical therapeutic effect in patients with IS
Patients will be recruited for this study if they meet all of the following criteria: (1) 40 ≤ age ≤ 80 years, (2) consistent with the western and Chinese medicine diagnostic criteria of IS, (3) meet the diagnostic criteria of TCM symptom differentiation (QDBS syndrome), (4) imaging confirmed anterior circulation infarction (Oxfordshire Community Stroke Project clinical classification of complete or partial anterior circulation infarction), (5) course of disease of 1–4 weeks, (6) 4 ≤ National Institute of Health Stroke Scale (NIHSS) score ≤ 20, (7) first attack or previous history of cerebral infarction but without disability before this attack, and (8) signed informed consent
Summary
Stroke is the second leading cause of death and a leading cause of disability worldwide (Feigin et al, 2014; Norberto et al, 2017). The evaluation of clinical efficacy after TCM treatment is mainly based on improvement of the patients’ syndromes (symptoms, tongue, and pulse). Invigorating Qi and activating blood circulation (Yiqi Huoxue in Chinese) is the most effective IS treatment in TCM, and its corresponding representative prescription is Buyang Huanwu decoction (BHD) proposed by Wang Qing-ren in the Qing dynasty. We will use similar prescriptions for invigorating Qi and activating blood circulation (BHD, NXTC, and YTG; compositions listed in Table 1) to carry out clinical and biological research on PSC. We will evaluate the level of PSC for Buyang Huanwu granules (BHG), NXTC, and YTG in IS with QDBS syndrome, identify helpful clinical biomarkers that are related to IS with QDBS syndrome, and provide an objective basis for precise TCM treatment that can improve clinical therapeutic effect in patients with IS
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
