Ginkgo Diterpene Lactone Meglumine(Ginkgo Diterpene Lactone Meglumine) - 在研适应症：急性缺血性卒中_专利_临床

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域

神经系统疾病心血管疾病

在研适应症

急性缺血性卒中

非在研适应症-

原研机构

上海中医药大学附属岳阳中西医结合医院

在研机构

上海中医药大学附属岳阳中西医结合医院

非在研机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)临床2/3期

特殊审评-

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关联

3

项与 Ginkgo Diterpene Lactone Meglumine 相关的临床试验

ChiCTR2300070949 / Suspended临床2期IIT

Efficacy and safety of Ginkgo biloba diterpene lactone glumine injection in patients with acute ischemic stroke: a randomized, double-blind, multi-dose, placebo-controlled Phase ? exploratory trial

开始日期2023-06-01

申办/合作机构-

NCT05531942 / Recruiting临床2/3期IIT

Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke:A Randomized, Double-blind, Placebo-controlled Clinical Trial

This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(100mg once/day D1-D14) in combination, while the other half will receive aspirin(100mg once/day D1-D14).

开始日期2021-01-01

申办/合作机构

上海中医药大学附属岳阳中西医结合医院

NCT05663307 / Recruiting临床2/3期IIT

The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic: A Randomized, Double Blind, Placebo Parallel Controlled Clinical Study

The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

开始日期2021-01-01

申办/合作机构

上海中医药大学附属岳阳中西医结合医院

100 项与 Ginkgo Diterpene Lactone Meglumine 相关的临床结果

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100 项与 Ginkgo Diterpene Lactone Meglumine 相关的转化医学

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100 项与 Ginkgo Diterpene Lactone Meglumine 相关的专利（医药）

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24

项与 Ginkgo Diterpene Lactone Meglumine 相关的文献（医药）

2024-06-01·Journal of Neurology

Efficacy of ginkgo diterpene lactone meglumine on cognitive function in patients with acute ischemic stroke: a predefined exploratory analysis of a multicenter, double-blind, randomized controlled trial

Article

作者: Tian, Xue ; Zhang, Yijun ; Xu, Qin ; Xia, Xue ; Meng, Xia ; Wang, Anxin

BACKGROUNDGinkgo diterpene lactone meglumine (GDLM) could improve the functional outcome in patients with acute ischemic stroke (AIS). This study aimed to investigate the efficacy of GDLM on cognitive function in patients with AIS.METHODSThis is a predefined exploratory analysis of the Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke trial, which was primarily designed to investigate the efficacy and safety of GDLM versus placebo on functional outcome at 100 centers in China. Cognitive function was measured using the Montreal Cognitive Assessment (MoCA) test. The primary outcomes were changes of MoCA from baseline to Day 14 and Day 90 after randomization.RESULTSA total of 3163 patients with completed data on MoCA were enrolled. There was statistically significant difference of changes in MoCA scores between the GDLM group and the placebo group from baseline to Day 14 (mean difference, 0.31; 95% confidence interval [CI], 0.08-0.53; P = 0.007) and to Day 90 after randomization (mean difference, 0.47; 95% CI, 0.22-0.72; P < 0.001). Additionally, GDLM was associated with a higher proportion of patients who reached a clinically significant level of improvement in MoCA from baseline to Day 14 (odds ratio [OR], 1.25; 95% CI, 1.08-1.44; P = 0.002) and Day 90 after randomization (OR, 1.21; 95% CI, 1.03-1.41; P = 0.02). Specially, GDLM could significantly improve the scores of visuo-spatial and executive function and language.CONCLUSIONSIn this predefined analysis of patients with AIS, GDLM could improve the 14-day and 90-day cognitive function compared with the placebo.

2024-03-13·Open Medicine

Effectiveness of ginkgo diterpene lactone meglumine on cognitive function in patients with acute ischemic stroke

Article

作者: Zhang, Meini ; Hu, Xiao ; Liu, Xianghong ; Wang, Tao

AbstractObjectiveTo explore the efficacy of ginkgo diterpene lactone (GDLM) on cognitive function in patients with acute ischemic stroke (AIS).MethodsA total of 126 patients with AIS in Shaanxi Provincial People’s Hospital from July 2019 to December 2020 were collected and randomly divided into the control group and treatment group (n = 63). All patients received conventional treatment, on which 25 mg/day GDLM was administered in the treatment group. Coagulation and inflammation indexes, National Institutes of Health Stroke Scale (NIHSS) and activities of daily living scale (ADL) scores were measured before and 14 days after treatment. NIHSS and ADL scores were performed again after 3 months. Cognitive function was assessed by Montréal Cognitive Assessment (MoCA) score, Mini-Mental State Examination (MMSE) score, and potential P300.ResultsAfter 14 days of treatment, all biochemical indices were lower than before treatment (P < 0.05). The NIHSS and ADL scores of the treatment group were significantly better than those of the control group after treatment (P < 0.05). The MoCA and MMSE scores of the treatment group improved more significantly compared with the control group (P < 0.05). After treatment, the P300 indexes of both groups were significantly better than before treatment (P < 0.05).ConclusionConventional treatment of AIS combined with GDLM can effectively improve the cognitive function of patients, which is worthy of clinical recommendation.

2024-01-19·Medicine

The efficacy and safety of diterpene ginkgolides meglumine injection for cerebral infarction: A meta-analysis of randomized controlled trials

Article

作者: Lin, Yifan ; Shi, Rui ; Zhang, Xiaomeng ; Wang, Haojia ; Cao, Huijuan ; Wu, Jiarui ; Li, Jiaqi

Objective:To systemically evaluate the efficacy and safety of diterpene ginkgolides meglumine injection (DGMI) on cerebral infarction (CI).Methods:Comprehensively collect randomized controlled trials of DGMI in the treatment of CI in 7 databases including Embase, PubMed, the Cochrane Library, the China National Knowledge Infrastructure Database, the WanFang Database, the China Science and Technology Journal Database, and the China Biology Medicinedisc as of January 2023. The studies were screened according to the inclusion and exclusion criteria and evaluated according to the criteria recommended by the Cochrane Handbook, then RevMan 5.3, Stata 12.0 software were used for Meta-analysis.Results:A total of 22 randomized controlled trials with 2194 patients were included. Meta analysis showed that: the total effective rate of treatment (relative risk = 1.29, 95% confidence interval (1.21, 1.38), P < .001), National Institute of Health stroke scale score, Barthel index and Modified Rankin Scale were better in DGMI group than in Conventional Western Medicine Treatment group. The included studies reported 42 adverse events, 25 of which belonged to DGMI groups.Conclusion:Available evidence suggested that DGMI can significantly improve the clinical efficiency in the treatment of CI. DGMI is an ideal treatment for CI, which has high clinical application value.

100 项与 Ginkgo Diterpene Lactone Meglumine 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性缺血性卒中	临床3期	中国	上海中医药大学附属岳阳中西医结合医院	2021-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ISC2024	N/A	急性缺血性卒中	3,452	Ginkgo diterpene lactone meglumine	築淵夢顧齋鹽憲衊蓋窪(製齋壓襯壓網製襯廠艱) = 顧繭構觸窪簾選網糧鏇鹽醖憲鹹襯鬱鬱網製鬱 (鹽憲築廠衊衊願構壓衊, 17.51 ~ 18.81)	积极	2024-02-01