دورية أكاديمية
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Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial.

التفاصيل البيبلوغرافية
العنوان: Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial.
المؤلفون: Long LZ; Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350112, China.; Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China., Chu JF; Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350112, China.; Chen Keji Academic Thought Inheritance Studio, Fujian University of Traditional Chinese Medicine, Fu Zhou, China.; Fujian Key Laboratory of Integrative Medicine on Geriatrics, Fujian University of Traditional Chinese Medicine, Fu Zhou, China., Qu H; National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.; Department of Cardiovascular Disease Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China., Yang QN; National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.; Department of Cardiovascular Disease Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China., Lu Y; Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350112, China., Fu CG; National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China. fucgbs@163.com.; Department of Cardiovascular Disease Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. fucgbs@163.com., Peng J; Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350112, China. pjunlab@hotmail.com., Chen KJ; National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.; Department of Cardiovascular Disease Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
المصدر: Trials [Trials] 2023 Jan 02; Vol. 24 (1), pp. 1. Date of Electronic Publication: 2023 Jan 02.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Hypertension*/diagnosis , Hypertension*/drug therapy , Drugs, Chinese Herbal*/adverse effects, Humans ; Double-Blind Method ; Treatment Outcome ; Valsartan/adverse effects ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
مستخلص: Background: Numerous pre-clinical studies showed that Qingda granule (QDG) was effective in treating hypertension. This study aims to evaluate the efficacy and safety of QDG in reducing blood pressure among patients with grade 1 hypertension at low-medium risk.
Methods: The study is designed as a randomized, multi-center, double-blinded, non-inferiority clinical trial. Five hundred fifty-two patients with grade 1 hypertension at low-medium risk from 13 hospitals will be recruited and randomly assigned to the QDG group (n = 276, treated with valsartan capsule simulation agent and QDG) or control group (n = 276, treated with valsartan capsule and QDG simulation agent). The treatment period will be 4 weeks and the follow-up period will last 4 weeks after treatment. Primary outcome will be a decreased value of systolic blood pressure and diastolic blood pressure after treatment. And second outcome will include the decreased value of diastolic blood pressure and systolic blood pressure at the end of follow-up, the percentage of participants achieving normal blood pressure at the end of treatment and follow-up, the Hamilton Anxiety Scale and TCM syndrome scores at the end of treatment and follow-up, and levels of hypertensive hormones at end of treatment and follow-up.
Discussion: This study will provide initial evidence regarding the clinical efficacy and safety of QDG in treating grade 1 hypertension at low-medium risk.
Trial Registration: Chinese Clinical Trial Registry ChiCTR2000033890 . Registered on 15 June 2020.
(© 2023. The Author(s).)
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معلومات مُعتمدة: 2019YZ014004 Technology Major Project of Fujian Province
فهرسة مساهمة: Keywords: Blood pressure; Hypertension; Qingda granule; Randomized controlled trials
المشرفين على المادة: 0 (qingda granules)
0 (Drugs, Chinese Herbal)
80M03YXJ7I (Valsartan)
تواريخ الأحداث: Date Created: 20230101 Date Completed: 20230103 Latest Revision: 20230111
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC9806902
DOI: 10.1186/s13063-022-07006-0
PMID: 36588157
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-022-07006-0