研究疾病:
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脑梗死恢复期
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研究疾病代码:
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I69.300×003
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Target disease:
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Cerebral infarction recovery period
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Target disease code:
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研究类型:
Study type:
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治疗研究
Treatment 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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探索性研究/预试验
Pilot clinical trial
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研究目的:
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?通过以阳性药为对照,观察萨病(脑梗死)患者治疗前后两组的蒙医证候量表、改良 Rankin 量表、Barthel 指数积分、NIHSS 评分变化及组间的差异及ELISA、WesternBlot指标,平价扫布德-9丸治疗萨病(脑梗死)恢复期的临床应用的有效性。
?通过实验室检查、不良事件、体格及神经系统检查等,评价扫布德-9丸治疗萨病(脑梗死)恢复期的临床应用的安全性。
?通过本次RCT研究,为蒙医治疗脑梗死临床指南(萨病蒙医诊疗指南)的优化和新药纳入提供循证医学证据。
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Objectives of Study:
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1.Through the modified Rankin scale, Barthel index score, NIHSS score changes and the differences between the two groups and ELISA, WesternBlot indexes were observed in the two groups before and after treatment of Sa disease (cerebral infarction), and the parity scan Saubude-9 Effectiveness of clinical application in the treatment of Sa disease (cerebral infarction) in the convalescent period.
2.Through laboratory tests, adverse events, physical and neurological examinations, etc., the safety of clinical application of Saubude-9 in the treatment of Sa disease (cerebral infarction) in the convalescent period was evaluated.
3.Through this RCT study, evidence-based medical evidence is provided to optimize the Mongolian medicine clinical guideline for treating cerebral infarction (Mongolian medicine diagnosis and treatment guideline) and the inclusion of new drugs.
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药物成份或治疗方案详述:
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治疗期:
(1) 观察组:服用蒙药扫布德-9,每晚睡前口服一次,每次15粒;
(2) 对照组:
●阳性对照组1:步长脑心通胶囊,每日口服三次、每次4粒;
●阳性对照组2:额尔敦-乌日勒,每晚睡前口服一次,一次15粒;
●所有病例均12周为1疗程。 (3)基础用药:观察组、对照组均口服阿司匹林肠溶片100mg,口服一次,一次1片; 疗程:所有病例均12周(90天)为1疗程。
随访期:
(1) 随访时间:入组后第4周、第8周、第12周。
(2) 随访对象:入组全部病例。
合并用药
除试验药物外,受试者所接受的其他任何治疗均应精确的记录在研究病历和病例报告表中,记录应包括药物的名称、剂量、服用日期及适应症。
(1)疗程中不得使用其他治疗本病证的中西药物;
(2)如疗程中伴有感染、高血压、高血糖及高脂血症等,均可对症处理并详细记录;
(3)疗程中出现的不良事件、不良反应的用药要详细记录。
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Description for medicine or protocol of treatment in detail:
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Treatment period:
(1) Observation group: take Mongolian medicine Saubude-9 orally once every night before going to bed, 15 capsules each time;
( 2 ) Control group :
?Positive control group 1: Buchang Naoxintong capsules, orally three times a day, 4 capsules each time;
?Positive control group 2: Erridun-Wuril, orally once every night before going to bed, 15 capsules at a time;
?In all cases, 12 weeks was a course of treatment.
(3)Basic medication: both the observation group and the control group took aspirin enteric-coated tablets 100 mg orally, once orally, 1 tablet at a time;
(4)The course of treatment: 12 weeks (90 days) is a course of treatment in all cases.
Follow-up period:
(1) Follow-up time: 4th, 8th, and 12th weeks after enrollment.
( 2 ) Follow-up objects: All patients enrolled.
Concomitant medication
In addition to the investigational drug, any other treatment received by the subject should be accurately recorded in the study medical record and case report form. The record should include the name of the drug, dosage, date of administration, and indications.
(1) Other Chinese and Western medicines for the treatment of this disease should not be used in the course of treatment;
(2) If the course of treatment is accompanied by infection, hypertension, hyperglycemia and hyperlipidemia, it can be treated symptomatically and recorded in detail;
(3) The adverse events and adverse reactions during treatment should be recorded in detail.
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纳入标准:
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① 符合西医脑梗死恢复期诊断标准;
② 本次发病符合前循环脑梗死诊断标准;
③ 符合蒙医萨病诊断标准;
④ 本次发病病程: 从发病之日起 15 ~ 45天;
⑤ 首次发病,或既往脑梗死病史者但本次发作前无残障者( 改良Rankin 量表评分≤1 分);
⑥ 采用美国国立卫生观察院脑卒中量表( NIHSS) 评分标准,神经功能缺损程度积分为≥7分,≤22 分;
⑦ 年龄≥40 周岁,≤75 周岁者;
⑧ 志愿受试,并签署知情同意书者。
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Inclusion criteria
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① Meet the diagnostic criteria of Western medicine for cerebral infarction in the convalescent period;
② The disease was in line with the diagnostic criteria for anterior circulation cerebral infarction;
③ Meet the diagnostic criteria of Mongolian medical Sa disease;
④ The course of the disease: 15 to 45 days from the date of onset;
⑤ The first onset, or those with a history of cerebral infarction but no disability before this onset (modified Rankin scale score ≤1 point);
⑥ Using the National Institutes of Health Observatory Stroke Scale (NIHSS) scoring standard, the score of neurological deficit was ≥7 points and ≤22 points;
⑦ Age ≥40 years old, ≤75 years old;
⑧ Volunteer subjects and signed informed consent.
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排除标准:
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⑴后循环脑梗死、腔隙性脑梗死、短暂性脑缺血发作( TIA) ;
⑵既往曾患脑血管病,并留有严重运动功能障碍者;
⑶影响药物评价的并发症,包括中风后的抑郁、痴呆、脑梗死后并发脑出血等;
⑷经检查证实由脑肿瘤、脑外伤、血液病等引起的中风患者;
⑸因风湿性心脏病、冠心病及其他心脏病合并房颤,引起脑栓塞者;
⑹合并有肝、 肾、造血系统、内分泌系统等严重疾病及骨关节病、精神病者,ALT、AST≥正常值上限的 2 倍,Cr > 正常值上限;
⑺有出血倾向者或 12 周内发生过严重出血者;
⑻合并严重高血压病或糖尿病等疾病,经治疗疾病仍未能控制者;
⑼缺少明确的影像学等诊断证据或影像学诊断证据不充分,不能确定诊断者;
⑽病情较重,出现昏迷影响疗效评价者;
⑾合并有其他影响肢体活动功能的疾病者,治疗前合并有骨关节炎、类风湿关节炎、痛风性关节炎等引起的肢体活动功能障碍可能影响神经或功能检查者;
⑿本次疾病前因为各种疾病和体质造成不能独立完成日常活动等严重影响疗效评价者;
⒀妊娠期或准备妊娠、哺乳期妇女;
⒁已知对本药物成分过敏及严重过敏体质者;
⒂3 个月内参加过其它药物临床试验者;
⒃4 周内使用过已知对主要脏器有损害的药物者;
⒄吞咽障碍不能服药者;进行过溶栓治疗的患者;
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Exclusion criteria:
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?Posterior circulation cerebral infarction, lacunar infarction, transient ischemic attack (TIA);
?Those who have suffered from cerebrovascular disease in the past and have severe motor dysfunction;
?Complications affecting drug evaluation, including depression after stroke, dementia, cerebral haemorrhage after cerebral infarction, etc.;
?Stroke patients confirmed by examination to be caused by a brain tumour, brain trauma, blood disease, etc.;
?Patients with cerebral embolism due to rheumatic heart disease, coronary heart disease and other heart disease combined with atrial fibrillation;
?Combined with severe disorders such as liver, kidney, hematopoietic system, endocrine system, osteoarthropathy, mental illness, ALT, AST ≥ 2 times the upper limit of normal, Cr > upper limit of normal;
?Those with a tendency to bleed or those with severe bleeding within 12 weeks;
?Combined with severe hypertension or diabetes and other diseases, those who cannot control the disease after treatment;
?Lack of clear diagnostic evidence such as imaging or insufficient imaging diagnostic evidence to determine the diagnosis;
?Severe illness or coma affects the evaluation of curative effect;
?Those with other diseases that affect the function of limb movement and those with limb movement dysfunction caused by osteoarthritis, rheumatoid arthritis, gouty arthritis, etc., which may affect the nerve or function examination before treatment;
?Those who were unable to independently complete daily activities due to various diseases and constitutions before the disease had a severe impact on the efficacy evaluation;
?Women who are pregnant or planning to become pregnant or breastfeeding;
?Those who are known to be allergic to the ingredients of this drug or have a severe allergic constitution;
?Those who have participated in clinical trials of other drugs within 3 months;
?Those who have used drugs known to major damage organs within 4 weeks;
?dysphagia who cannot take medicine; patients who have undergone thrombolytic therapy;
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研究实施时间:
Study execute time:
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从From
2022-06-01
至To
2023-06-01
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征募观察对象时间:
Recruiting time:
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从From
2022-06-01
至To
2023-06-01
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