研究疾病:
|
中风病(脑梗死)恢复期(阴虚风动证)
|
研究疾病代码:
|
|
Target disease:
|
stroke (cerebral infarction)
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
上市后药物
Post-marketing clinical trial
|
研究目的:
|
主要目的:以灯盏生脉胶囊为阳性对照,评价脉络宁颗粒治疗中风病(脑梗死)恢复期(阴虚风动证)的有效性。
次要目的:评价脉络宁颗粒治疗中风病(脑梗死)恢复期(阴虚风动证)的安全性。
|
Objectives of Study:
|
Primary Objective: To evaluate the efficacy of Mailuoning Granules in the treatment of stroke (cerebral infarction) convalescence (Syndromes of Stirring Wind due to Yin Deficiency) with Dengzhanshengmai Capsule as the positive control.
Secondary Objective: To evaluate the safety of Mailuoning Granules in the treatment of stroke (cerebral infarction) convalescence (Syndromes of Stirring Wind due to Yin Deficiency)
|
药物成份或治疗方案详述:
|
成份:牛膝、玄参、石斛、金银花、山银花(灰毡毛忍冬)
方案详述:本研究采用多中心、随机、双盲双模拟、阳性药平行对照,采用优效性设计。计划纳入96例中风病(脑梗死)恢复期(阴虚风动证)患者。入选的合格受试者以2:1的比例被随机分配到脉络宁颗粒组和阳性药灯盏生脉胶囊对照组。治疗期:12周;研究中于用药第0天,第4周、第8周、第12周末各访视一次;此外,研究停药后随访4周。
|
Description for medicine or protocol of treatment in detail:
|
Ingredients: Achyranthes bidentalis, Scrophulariae, Dendrobium, Honeysuckle, Lonicerae
A multi-centered, randomized, double-blind, double-dummy, parallel-controlled clinical study of positive drugs was conducted in this study.
A total of 96 patients who suffered from stroke (cerebral infarction) convalescence (Syndromes of Stirring Wind due to Yin Deficiency) were planned to be included. All eligible patients were randomized in a 2:1 ratio into the Mailuoning Granule group and the positive drug Dengzhanshengmai Capsule control group. Treatment period: 12 weeks; Visits were made on Day 0, Weeks 4, 8, and 12 of the study. In addition, study discontinuation was followed for 4 weeks.
|
纳入标准:
|
符合以下全部标准的受试者可入选本研究:
1)年龄在40~80周岁,男女均可;
2)符合西医脑梗死恢复期诊断标准;
3)符合中医中风病(脑梗死)恢复期(阴虚风动证)辨证标准;
4)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);
5)采用美国国立卫生研究院脑卒中量表(NIHSS)评分标准,神经功能缺损程度积分为≥7分,≤22分;
6)本次发病病程:从发病之日起15~90天;
7)受试者必须在试验前对本试验知情同意、并对试验内容、过程及可能出现的不良反应充分了解,能够与研究者进行良好的沟通并能够依照方案规定完成试验,且自愿签署了书面的知情同意书。
|
Inclusion criteria
|
Patients who met all of the following criteria were eligible for inclusion in the study:
1) Ages 40 to 80, regardless of gender;
2) Patients accord to diagnostic standards on western medical cerebral infarction convalescence;
3) Patients accord to syndrome differentiation criteria for stroke (cerebral infarction) convalescence (Syndromes of Stirring Wind due to Yin Deficiency) in TCM;
4) First onset of disease; Or previous history of cerebral infarction but no disability before this attack (modified Rankin scale score ≤1 point);
5) According to the National Institutes of Health Stroke Scale (NIHSS) score, the neurological deficit score was ≥7 points and ≤22 points;
6) Course of onset: 15~90 days from the date of onset;
7) prior to the trial, patients must give informed consent to the trial, fully understand the trial content, process and possible adverse reactions, be able to communicate with researchers well, and be able to complete the trial in accordance with the protocol provisions, and sign a written informed consent form voluntarily, and voluntarily sign a written informed consent.
|
排除标准:
|
符合以下任一标准的受试者,不得入选本研究:
1)后循环脑梗死、腔隙性脑梗死、短暂性脑缺血发作(TIA);
2)既往曾患脑血管病,并留有严重运动功能障碍者;
3)影响药物评价的并发症,包括中风后的抑郁(汉密尔顿抑郁量表评分≥7分)、痴呆、脑梗死后并发脑出血等;
4)经检查证实由脑肿瘤、脑外伤、血液病等引起的中风患者;
5)心源性脑栓塞者;
6)筛选时血糖控制不佳,空腹血糖>11.1mmol/L,或伴有严重糖尿病并发症影响疗效判定的患者;
7)筛选时血压持续升高控制不佳(收缩压≥180 mmHg,或舒张压≥100 mmHg)者;
8)有出血倾向者或12周内发生过严重出血者;
9)病情较重,出现昏迷影响疗效评价者;
10)本次疾病前因为其他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;
11)筛选时合并严重肝、肾(谷丙转氨酶、谷草转氨酶>正常值的1.5倍,或肌酐超过正常值上限1.5倍)疾病、造血系统等严重原发性疾病及功能障碍患者;精神病患者;严重的风湿免疫疾病、严重骨关节病影响运动功能者;
12)筛选前2周内进行过溶栓治疗的患者;
13)筛选前1个月内使用过已知对主要脏器有重大损害的药物者;
14)已知对试验药物(包括其组方成份)过敏的患者;
15)吞咽障碍不能服药者;
16)筛选前3个月内参加过药物临床试验者;
17)妊娠期、计划妊娠或哺乳期女性患者;
18)其他未能规定但研究者认为不宜参加本临床试验的患者。
|
Exclusion criteria:
|
Patients who met any of the following criteria were excluded from the study:
1) Patients accompany with posterior circulation cerebral infarction, lacunar cerebral infarction, transient Ischemic attack (TIA);
2) Patients suffered from cerebrovascular disease and have severe motor dysfunction before;
3) Complications affecting drug evaluation included post-stroke depression (Hamilton Depression Scale score ≥7), dementia, cerebral hemorrhage after cerebral infarction, etc;
4) Stroke patients confirmed by examination to be caused by brain tumors, brain trauma, hematological diseases, etc.;
5) Patients with cardiogenic cerebral embolism;
6) Patients with poor blood glucose control during screening, fasting blood glucose >11.1mmol/L, or patients with severe diabetic complications affected the efficacy assessment;
7) Patients with poor control of continuous elevated blood pressure during screening (systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥100 mmHg);
8) Patients with bleeding tendency or patients with severe bleeding within 12 weeks;
9) Patients with severe illness and coma influencing efficacy evaluation;
10) Patients who were unable to complete daily activities independently due to various other diseases and constitutions before this disease, which seriously affected the efficacy evaluation;
11) Screening patients combined with severe liver and kidney (alanine aminotransferase, aspartate aminotransferase > 1.5 times of normal, or creatinine exceeding 1.5 times of the upper limit of normal) diseases, hematopoietic system and other serious primary diseases and dysfunction; Psychiatric patients; Patients with severe rheumatic immune diseases or severe osteoarthropathy that affect motor function;
12) Patients received thrombolytic therapy within the 2 weeks prior to screening;
13) Patients used drugs known to have significant damage to the main organs within 1 month before screening;
14) Patients known to be allergic to the investigational drug (including its components);
15) People with dysphagia cannot take medicine;
16) Patients participated in clinical trials of drugs within 3 months before screening;
17) Female patients during pregnant, planning for pregnancy or lactation;
18) Other patients not specified but considered by the investigator to be not suitable for participating in this clinical trial.
|
研究实施时间:
Study execute time:
|
从From
2022-07-01
至To
2023-12-31
|
征募观察对象时间:
Recruiting time:
|
从From
2022-12-25
至To
2023-12-31
|