Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial
| Autor: | Yan-jie Gao, Shan Ren, Ling Wei, Hong-lin Li, Hong Wang, Na Zhang, Yun-hai Liu, Guo-xiong Lu, Zhi-gang Chen, Xu-zheng Cao, Mei Zhang, Jin-tao Zhang, Lu-ran Liu, Hong-tao Wei, Bin Xu, Ji-hua Zhang, Lu Chen, Miao Yang, Rong-hua Tang, Wen-zong Zhu, Qian-yu Zhao, Chi Zhong, Li-ping Ma |
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| Rok vydání: | 2020 |
| Předmět: |
0211 other engineering and technologies
02 engineering and technology Placebo 030226 pharmacology & pharmacy law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law 021105 building & construction medicine Pharmacology (medical) Adverse effect Aspirin biology business.industry Ginkgo biloba Incidence (epidemiology) General Medicine biology.organism_classification Blood pressure Complementary and alternative medicine Anesthesia business medicine.drug |
| Zdroj: | Chinese Journal of Integrative Medicine. 27:252-258 |
| ISSN: | 1993-0402 1672-0415 |
| Popis: | To evaluate whether the efficacy of Getong Tongluo Capsule (葛酮通络胶囊, GTC, consisted of total flavone of Radix Puerariae) on improving patients’ quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba (EGB) for patients with convalescent-phase ischemic stroke and primary hypertension. This randomized, positive-drug- and placebo-controlled, double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions, twice a day for 12 weeks: (1) GTC 250 mg plus EGB-matching placebo 40 mg (237 cases, GTC group), (2) EGB 40 mg plus GTC-matching placebo 250 mg (120 cases, EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases, placebo group). Moreover, all patients were orally administered aspirin enteric-coated tablets 100 mg, once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed. The BI relative independence rates, the clinical recovery rates of NIHSS, and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (P 0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12, 18 and 24 weeks after treatment (P 0.05). GTC exhibited significant efficacy in improving patients’ quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667) |
| Databáze: | OpenAIRE |
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