{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T11:15:29Z","timestamp":1774869329154,"version":"3.50.1"},"reference-count":32,"publisher":"BMJ","issue":"11","funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,9,20]]},"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>After stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>In this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30\u00b12 and the third visit on day 210\u00b15. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-015983","type":"journal-article","created":{"date-parts":[[2017,11,9]],"date-time":"2017-11-09T01:05:33Z","timestamp":1510189533000},"page":"e015983","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Naoxuekang, Xinnaoshutong and Xuesaitong capsules for treating stroke: a protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1691-6024","authenticated-orcid":false,"given":"Huiling","family":"Chen","sequence":"first","affiliation":[{"name":"School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China"},{"name":"School of Chinese Medicine Engineering, Tianjin University of Traditional Chinese Medicine, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongbo","family":"Cao","sequence":"additional","affiliation":[{"name":"Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xu","family":"Guo","sequence":"additional","affiliation":[{"name":"School of Language and Culture, Tianjin University of Traditional Chinese Medicine, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meidan","family":"Zhao","sequence":"additional","affiliation":[{"name":"College of Acupuncture and Massage, Tianjin University of Traditional Chinese Medicine, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qing","family":"Xia","sequence":"additional","affiliation":[{"name":"College of Acupuncture and Massage, Tianjin University of Traditional Chinese Medicine, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bo","family":"Chen","sequence":"additional","affiliation":[{"name":"College of Acupuncture and Massage, Tianjin University of Traditional Chinese Medicine, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tieniu","family":"Zhao","sequence":"additional","affiliation":[{"name":"School of Chinese Medical, Tianjin University of Traditional Chinese Medicine, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenyuan","family":"Gao","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2017,11,8]]},"reference":[{"key":"2025120618475707000_7.11.e015983.1","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.26.12.2222"},{"key":"2025120618475707000_7.11.e015983.2","first-page":"36","article-title":"Analyze on the application principle of Chinese patent medicine and the situation of irrational drug use [in Chinese]","volume":"7","author":"Yang","year":"2009","journal-title":"Clinical drug therapy"},{"key":"2025120618475707000_7.11.e015983.3","first-page":"462","article-title":"Evaluation the clinical efficacy and safety of traditional Chinese medicine which promoting blood circulation, removing blood stasis, supplementing qi and dredging collaterals combined with western medicine in the treatment of ischemic stroke [in Chinese]","volume":"20","author":"Yang","year":"2012","journal-title":"Practical journal of cardiac cerebral pneumal and vascular disease"},{"key":"2025120618475707000_7.11.e015983.4","first-page":"164","article-title":"Curative effect observation of Xianfanghuoming decoction combined with western medicine in the treatment of qi stagnation and phlegm type of stroke [in Chinese]","volume":"12","author":"ZX","year":"2010","journal-title":"Chinese health nutrition"},{"key":"2025120618475707000_7.11.e015983.5","first-page":"1873","article-title":"Analysis of the application of Chinese and western medicine in the treatment of stroke rehabilitation [in Chinese]","volume":"5","author":"Rao","year":"2010","journal-title":"Journal of Traditional Chinese Medicine"},{"key":"2025120618475707000_7.11.e015983.6","first-page":"2008","article-title":"Curative effect observation of 80 cases of acute cerebral infarction treated with NaoxueKang capsule [in Chinese]","volume":"17","author":"Wang","year":"2004","journal-title":"Shanxi Med Journal"},{"key":"2025120618475707000_7.11.e015983.7","first-page":"940","article-title":"Effects of Naoxuekang capsules on hemorrheology of cerebral infarction patients [in Chinese]","volume":"8","author":"Gao","year":"2007","journal-title":"HeBei Medicine"},{"key":"2025120618475707000_7.11.e015983.8","unstructured":"Chinese Pharmacopoeia Commission. Pharmacopoeia of the People\u2019s Republic of China. Chinese medicine science and technology press, 2015:111."},{"key":"2025120618475707000_7.11.e015983.9","first-page":"60","article-title":"Summary of clinical application of cardiac and Xinnaoshutong Capsule [in Chinese]","volume":"7","author":"Qu","year":"2011","journal-title":"China Health Industry"},{"key":"2025120618475707000_7.11.e015983.10","first-page":"167","article-title":"The clinical treatment effective analysis of cerebral infarction sequelae of Xinnaoshutong capsule","volume":"2","author":"Lin","year":"2012","journal-title":"Chinese Journal of Intergartive Medicine on Cardio\/Cerebrovasascular Disease"},{"key":"2025120618475707000_7.11.e015983.11","first-page":"26","article-title":"Pharmacopoeia of the People\u2019s Republic of China","volume":"16","author":"Chinese Pharmacopoeia Commission","year":"2015","journal-title":"Chinese medicine science and technology press"},{"key":"2025120618475707000_7.11.e015983.12","first-page":"1058","article-title":"To observe the clinical curative effect of Xuesaitong soft capsule in the treatment of stroke [in Chinese]","volume":"5","author":"Sy","year":"2010","journal-title":"Hebei Medical Journal"},{"key":"2025120618475707000_7.11.e015983.13","first-page":"4552","article-title":"Efficacy observation of Xuesaitong soft capsule on the improvement of life self-care ability in patients with cerebral infarction","volume":"48","author":"SY","year":"2012","journal-title":"China Pharmacy"},{"key":"2025120618475707000_7.11.e015983.14","first-page":"108","volume-title":"Pharmacopoeia of the People\u2019s Republic of China","volume":"17","author":"Chinese Pharmacopoeia Commission","year":"2015"},{"key":"2025120618475707000_7.11.e015983.15","doi-asserted-by":"publisher","DOI":"10.1200\/JOP.0926001"},{"key":"2025120618475707000_7.11.e015983.16","unstructured":"National Information Center on Health Services Research and Health CareTechnology (NICHSR). Comparative Effectiveness Research (CER). U.S: National Library of Medicine, 2014. http:\/\/www.nlm.nih.gov\/hsrinfo\/cer.html. (accessed 7 Mar 2014)."},{"key":"2025120618475707000_7.11.e015983.17","first-page":"489","article-title":"Using medicare data for comparative effectiveness research: opportunities and challenges","volume":"17","author":"Fung","year":"2011","journal-title":"Am J Manag Care"},{"key":"2025120618475707000_7.11.e015983.18","first-page":"85","article-title":"Investigation of comparative effectiveness research in Asia, Europe, and North America","volume":"47","author":"Patel","year":"2015","journal-title":"Indian J Pharmacol"},{"key":"2025120618475707000_7.11.e015983.19","unstructured":"National Information Center on Health Services Research and Health CareTechnology (NICHSR). National Institutes of Health: Comparative Effectiveness Research (CER). Bethesda: National Library of Medicine, 2014. http:\/\/www.nlm.nih.gov\/hsrinfo\/cer.html. (accessed 7 Mar 2014)."},{"key":"2025120618475707000_7.11.e015983.20","doi-asserted-by":"crossref","first-page":"1465","DOI":"10.1111\/acem.12831","article-title":"Comparative effectiveness research: alternatives to \"Traditional\" computed tomography use in the acute care setting","volume":"22","author":"Moore","year":"2015","journal-title":"Acad Emerg Med"},{"key":"2025120618475707000_7.11.e015983.21","doi-asserted-by":"crossref","first-page":"92","DOI":"10.3163\/1536-5050.101.2.004","article-title":"Comparative effectiveness research designs: an analysis of terms and coverage in Medical Subject Headings (MeSH) and Emtree","volume":"101","author":"Bekhuis","year":"2013","journal-title":"J Med Libr Assoc"},{"key":"2025120618475707000_7.11.e015983.22","doi-asserted-by":"publisher","DOI":"10.1016\/j.jht.2014.07.001"},{"key":"2025120618475707000_7.11.e015983.23","first-page":"342","article-title":"Development and verification of validity and reliability of the WHOQOL-BREF Taiwan version","volume":"101","author":"Yao","year":"2002","journal-title":"J Formos Med Assoc"},{"key":"2025120618475707000_7.11.e015983.24","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-009-9471-5"},{"key":"2025120618475707000_7.11.e015983.25","unstructured":"Society for clinical data management. Good Clinical Data Management practice guidance document [Online]. 2007 http:\/\/www.scdm.org\/sitecore\/content\/be-bruga\/scdm\/Publications\/gcdmp.aspx\/"},{"key":"2025120618475707000_7.11.e015983.26","first-page":"542","article-title":"Influencing factors of the quality of life in patients with acute stroke","volume":"9","author":"Jb","year":"2005","journal-title":"Chin J Phys Med Rehabjl"},{"key":"2025120618475707000_7.11.e015983.27","first-page":"796","article-title":"Effect in quality of life of scalp acupuncture for long time combined with rehabilitation training on the stroke patients with cognitive disfunction","volume":"4","author":"Jm","year":"2010","journal-title":"Chinese Archives of Traditional Chinese Medicine"},{"key":"2025120618475707000_7.11.e015983.28","first-page":"101","article-title":"Effect of health education on the quality of life of stroke patients","volume":"9","author":"Qiu","year":"2008","journal-title":"Asia-Pacific Traditional Medicine"},{"key":"2025120618475707000_7.11.e015983.29","first-page":"2014","article-title":"Treatment Effective of ischemic stroke for limb dysfunction by internal and external wiping combined with pricking blood and cupping therapy with Tongfu Huatan Decoction","volume":"25","author":"Meng","year":"2016","journal-title":"Modern Journal of Integrated Traditional Chinese and Western Medicine"},{"key":"2025120618475707000_7.11.e015983.30","first-page":"38","article-title":"Clinical study on treatment of acute cerebral hemorrhage with NaoXueKang","volume":"5","author":"Zhao","year":"1995","journal-title":"Chin J Crit Care Med"},{"key":"2025120618475707000_7.11.e015983.31","first-page":"574","article-title":"Effect of Xuesaitong soft capsule on acute lacunar cerebral infarction combined with cerebral microbleeds","volume":"22","author":"Wang MH","year":"2017","journal-title":"Chinese Journal of Clinical Pharmacology and Therapeutics"},{"key":"2025120618475707000_7.11.e015983.32","first-page":"866","article-title":"Clinical observation on treatment of acute cerebral infarction with XinnaoShuTong","volume":"12","author":"Huang","year":"2010","journal-title":"Journal of Changchun University of Traditional Chinese Medicine"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2017-015983","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,7]],"date-time":"2025-12-07T02:48:12Z","timestamp":1765075692000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2017-015983"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,11]]},"references-count":32,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2017,11,8]]},"published-print":{"date-parts":[[2017,11]]}},"alternative-id":["10.1136\/bmjopen-2017-015983"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2017-015983","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,11]]}}}