NCT07690020尚未招募不适用
Clinical Efficacy and Mechanism Research of Getong Tongluo Capsule in Ischemic Stroke
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 216
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this single-center, randomized, double-blind, controlled trial is to clarify the clinical efficacy and safety of Getong Tongluo Capsule in patients with ischemic stroke. Combined with gut microbiome and metabolomics techniques, investigators will explore whether this medicine exerts neuroprotective effects via the gut-brain axis. Investigators will further verify its pharmacological mechanism through animal experiments to provide evidence for its clinical application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form
- •Aged between 18 and 80 years old
- •Conform to the diagnosis of acute ischemic stroke referring to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)
- •Hospital admission within 21 days after disease onset
排除标准
- •Patients with mild or no neurological deficits on admission: those with a score of 0 on the Modified Rankin Scale (mRS) at admission (defined as completely asymptomatic).
- •Patients with severe baseline disability: those with a pre-stroke mRS score ≥ 3 (indicating moderate to severe disability requiring partial or full assistance with activities of daily living).
- •Patients with transient ischemic attack, concomitant cerebral hemorrhage or subarachnoid hemorrhage; those complicated with brain tumor, Alzheimer's disease, psychiatric disorders, or suspected pre-stroke cognitive dysfunction.
- •Patients complicated with severe cardiac diseases including valvular heart disease, infective endocarditis, myocardial infarction and heart failure; severe hepatic or renal insufficiency, respiratory failure, malignant tumors, or massive gastrointestinal hemorrhage.
- •Patients who received any preparations containing the same active ingredients as the study drug (e.g., Pueraria lobata) within 2 weeks prior to stroke onset.
- •Patients with a history of allergy to the study drug or preparations with identical active ingredients.
- •Patients who received antibiotics within 1 month before onset; those taking probiotics or prebiotics long-term; patients with a past or in-hospital confirmed gastrointestinal disease history.
- •Pregnant and lactating women.
- •Patients deemed unsuitable for participation in this trial at the investigator's discretion.
结局指标
主要结局
Incidence of adverse events
时间窗: Through study completion, an average of 6 months
Distribution of modified Rankin Scale (mRS) scores
时间窗: Baseline, 3-month follow-up and 6-month follow-up
Scores range from 0 (no symptoms) to 6 (death); higher scores indicate poorer functional recovery
次要结局
- Athens Insomnia Scale (AIS) score(Baseline, 3-month follow-up and 6-month follow-up)
- Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement(Baseline, 3-month follow-up and 6-month follow-up)
- Activities of Daily Living (ADL) score(Baseline, 3-month follow-up and 6-month follow-up)
- Hamilton Depression Rating Scale (HAMD) score(Baseline, 3-month follow-up and 6-month follow-up)
- Hamilton Anxiety Rating Scale (HAMA) score(Baseline, 3-month follow-up and 6-month follow-up)
- Montreal Cognitive Assessment (MoCA) score(Baseline, 3-month follow-up and 6-month follow-up)
- MMSE score(Baseline, 3-month follow-up and 6-month follow-up)
- Incidence rate of drug-related adverse reactions(Through study completion, an average of 6 months)
研究者
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