研究疾病:
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原发性脑出血
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研究疾病代码:
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Target disease:
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Intracerebral Hemorrhage
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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本课题拟通过多中心、随机、双盲、安慰剂对照临床研究,观察蛭龙活血通瘀胶囊对脑出血恢复期患者的中医病症状分级量化评分、神经功能症状评分、影像学指标及血清学指标的影响,评价蛭龙活血通瘀胶囊治疗脑出血恢复期的有效性和安全性,为中医药防治脑出血恢复期提供高质量循证医学证据,形成和优化脑出血恢复期中西医结合综合诊疗方案。同时,通过蛋白质组学研究方法检测相关指标,探讨该药治疗脑出血恢复期患者作用机制及潜在靶点,为临床决策提供参考依据。丰富和拓展中医学的“玄府理论”内涵,为推广脑出血恢复期中西医结合综合诊疗方案提供数据支撑。
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Objectives of Study:
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This study aims to conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to observe the effects of Zhilong Huoxue Tongyu Capsules on the traditional Chinese medicine (TCM) symptom grading quantification, neurological symptom scoring, imaging indicators, and serological indicators in patients during the recovery phase of intracerebral hemorrhage. The objective is to evaluate the efficacy and safety of Zhilong Huoxue Tongyu Capsules in treating patients in the recovery phase of intracerebral hemorrhage, providing high-quality evidence based on evidence-based medicine for the prevention and treatment of this condition using TCM. This study will also form and optimize a comprehensive diagnosis and treatment plan that integrates traditional Chinese and Western medicine for patients recovering from intracerebral hemorrhage. Additionally, proteomic research methods will be employed to detect relevant indicators, explore the mechanisms of action and potential targets of the drug in treating patients during the recovery phase of intracerebral hemorrhage, and provide reference for clinical decision-making. The study will enrich and expand the connotation of the "Xuanfu Theory" in traditional Chinese medicine, offering data support for promoting the integrated treatment plan of traditional Chinese and Western medicine for the recovery phase of intracerebral hemorrhage
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药物成份或治疗方案详述:
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1、基础治疗方案
根据《中国脑出血诊治指南 (2019年)》制定。
2、中医药治疗方案
对照组使用基础治疗方案+安慰剂,[口服,一次三颗(1.05g),一天三次,连续服用28天],安慰剂规格、标签、外包装、外形、气味均与蛭龙活血通瘀胶囊一致
试验组使用基础治疗方案+蛭龙活血通瘀胶囊;[口服,一次三颗(1.05g),一天三次,连续服用28天]。若患者在此期间出院,嘱其蛭龙活血通瘀胶囊在出院后继续使用。
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Description for medicine or protocol of treatment in detail:
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1. Basic Treatment Plan
Developed based on the "Guidelines for the Diagnosis and Treatment of Intracerebral Hemorrhage in China (2019)."
2. Traditional Chinese Medicine Treatment Plan
The control group will receive the basic treatment plan plus a placebo, [taken orally, three capsules (1.05g) each time, three times a day, for a continuous period of 28 days]. The specifications, labeling, packaging, appearance, and smell of the placebo will be identical to those of Zhilong Huoxue Tongyu Capsules.
The experimental group will receive the basic treatment plan plus Zhilong Huoxue Tongyu Capsules; [taken orally, three capsules (1.05g) each time, three times a day, for a continuous period of 28 days]. If a patient is discharged during this period, they will be instructed to continue taking Zhilong Huoxue Tongyu Capsules after discharge.
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纳入标准:
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① 符合西医脑出血恢复期的诊断标准,发病时间为2周到2个月。
② 出血部位:幕上、基底节区,且血肿未破入脑室者;
③ 出血量在30ml以下者;
④ 发病年龄:40 岁≤年龄≤75 岁;
⑤ 首次发病或既往患中风(缺血性或出血性)但未遗留后遗症;
⑥ 心、肝、肾、血液系统等无严重功能障碍者;
⑦ 患者和/或授权委托人知情同意并签署知情同意书。
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Inclusion criteria
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1.Diagnosis must meet the criteria for recovery from cerebral hemorrhage in Western medicine, with the onset of the condition between 2 weeks and 2 months.
2.Location of hemorrhage: Supratentorial or basal ganglia regions, and the hematoma has not ruptured into the ventricles.
3.Hemorrhage volume: Less than 30 ml.
4.Age of onset: Between 40 and 75 years old (inclusive).
5.First occurrence of the disease or previous history of stroke (ischemic or hemorrhagic) without residual sequelae.
6.No severe functional impairment of the heart, liver, kidneys, blood system, etc.
7.The patient and/or authorized representative must provide informed consent and sign the informed consent form.
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排除标准:
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① 各种原因的继发性脑出血(包括颅内动脉瘤破裂、动静脉畸形或肿瘤出血、药物相关性脑出血者等),蛛网膜下腔出血,混合性卒中,多灶性出血,脑疝形成,中线结构移位超过5mm,同侧侧脑室受压闭塞超过1/2,同侧脑池、脑沟模糊或消失;
② 消化道溃疡及有出血倾向者;
③有严重并发症,如严重感染、昏迷等;
④骨关节病、精神病、严重痴呆等影响临床评价者;
⑤妊娠或哺乳期妇女;
⑥对本方案中药成分过敏者;
⑦同时参加其他药物临床试验者;
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Exclusion criteria:
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1.Secondary intracerebral hemorrhage due to various causes (including ruptured intracranial aneurysm, arteriovenous malformation or tumor bleeding, drug-related cerebral hemorrhage, etc.), subarachnoid hemorrhage, mixed stroke, multifocal hemorrhage, brain herniation, midline structure displacement greater than 5 mm, compression and obstruction of the same-sided lateral ventricle exceeding 1/2, and blurring or disappearance of the same-sided cistern and sulcus.
2.Gastrointestinal ulcers and individuals with a tendency to bleed.
3.Presence of severe complications, such as severe infections, coma, etc.
4.Bone and joint diseases, psychiatric disorders, severe dementia, etc., that affect clinical evaluation.
5.Pregnant or breastfeeding women.
6.Individuals allergic to the herbal components in this protocol.
7.Participants currently involved in other drug clinical trials.
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研究实施时间:
Study execute time:
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从From
2024-03-03
至To
2025-03-31
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征募观察对象时间:
Recruiting time:
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从From
2024-09-10
至To
2025-03-31
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