Efficacy of Yangyin Yiqi Huoxue Granule () in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial.
10.1007/s11655-021-2857-0
- Author:
Yu WANG
1
;
Jie-Hong YANG
1
;
Hai-Tong WAN
2
;
Yu HE
1
;
Bin XU
3
;
Chang-Shan AI
4
;
Hui-Fen ZHOU
1
;
Li YU
1
;
Hao-Fang WAN
1
;
Xiao-Dong BIE
5
Author Information
1. Institute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China.
2. Institute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China. whtong@126.com.
3. Neurology Department, Xinhua Hospital of Zhejiang Province, Hangzhou, 310005, China.
4. Neurology Department, Integrated Medicine Hospital of Jilin Province, Yanbian, Jilin Province, 133001, China.
5. Chinese Medicine Department, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310000, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Chinese medicine;
qi-yin deficiency and blood stasis syndrome;
randomized controlled trial;
stroke
- MeSH:
Activities of Daily Living;
Brain Ischemia/drug therapy*;
Humans;
Ischemic Stroke;
Qi;
Quality of Life;
Stroke/drug therapy*;
Yin Deficiency
- From:
Chinese journal of integrative medicine
2021;27(11):811-818
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (, YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin deficiency and blood stasis syndrome (QYDBSS), and to explore its effective dosage.
METHODS:The total of 288 patients were randomly assigned to the YYHG high-dose, YYHG low-dose, positive control (administered Xiaoshuantong Granule, XSTG, ), or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period, with a 180-day follow-up period. The primary outcome was the comprehensive curative evaluation, and secondary outcomes were the National Institute of Health Stroke Scale (NIHSS) score, Barthel activities of daily living (ADL) index score, the quality of life index (QLI) score, and the Chinese medicine syndrome (CMS) score. All analyses were done on an intention-to-treat basis. The clinical safety was also assessed.
RESULTS:The total of 288 participants were recruited between June 1, 2008 and September 30, 2009, and 287 patients received intervention; the treatment groups were well balanced at baseline. The comprehensive cure rates of YYHG high-dose, low-dose, positive and placebo control groups were 63.38%, 31.94%, 36.11% and 6.14%, respectively; there was a statistical difference between the two groups (P<0.01), while the high-dose YYHG treatment group was significantly higher than the other 3 groups (P<0.01). The improvement of NIHSS, ADL, QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group (P<0.05). In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale, the YYHG high-dose group was significantly better than the other three groups (P<0.05), and the YYHG low-dose group was better than the placebo control group (P<0.01). At the same time, except for the QLI score, the high-dose group was better than the low-dose group (P<0.05). In terms of safety, adverse reactions after YYHG treatment were generally mild (3.78%), and no serious adverse reactions have been reported.
CONCLUSION:YYHG is safe and effective in the treatment of IS patients with QYDBSS.
