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【ChiCTR2100049126】Efficacy of Thiamine in Patients with Clinically Suspected Dry Beriberi: An Open Labeled Hospital Based Study in Bangladesh

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基本信息

登记号

ChiCTR2100049126

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2021-07-21

临床申请受理号

靶点

适应症

dry beriberi

试验通俗题目

Efficacy of Thiamine in Patients with Clinically Suspected Dry Beriberi: An Open Labeled Hospital Based Study in Bangladesh

试验专业题目

Efficacy of Thiamine in Patients with Clinically Suspected Dry Beriberi: An Open Labeled Hospital Based Study in Bangladesh

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

4203

联系人通讯地址

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临床试验信息

试验目的

General objective: To evaluate the efficacy of Thiamine in patients with suspected / possible dry beriberi Specific objectives: 1. To describe the socio-demographic profile of patients; 2. To categorize the patients according to their presenting symptoms and signs; 3. To assess and compare pre and post treatment neurological features.

试验分类

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试验类型

单臂

试验分期

回顾性研究

随机化

N/A

盲法

N/A

试验项目经费来源

self funding

试验范围

目标入组人数

实际入组人数

第一例入组时间

2018-07-01

试验终止时间

2018-06-30

是否属于一致性

入选标准

1. Any person admitted to CMCH as a Suspected/Possible dry-beriberi. Risk factors + at least 2 of the following signs: Risk factors include Imbalanced diet (diet poor in thiamine/rich in carbohydrate or anti-thiamine factors), malnutrition, alcoholism, GIT surgery, chronic diarrhoea, chronic vomiting, pregnancy or history of recent delivery, chronic. diuretics use, renal dialysis, total parenteral nutrition. 1) Muscle weakness of upper and or lower limb (less than grade 5 power in MRC scale); 2) Positive sensory symptoms (burning, tingling or pain); 3) Objective sensory deficit (pain, touch, position, vibration sense); 4) Absent or reduced deep tendon reflexes; 5) Positive squat test (unable to rise after squatting without help);6) Leg swelling; 2. Aged 18 years and above.；

排除标准

1. Patients with isolated cardiac/wet beriberi; 2. Patient with known causes of peripheral neuropathy such as Diabetic, hereditary, Demyelinating (GBS, CIDP), metabolic (hepatic/renal impairment), drugs (e.g. INH, Ethambutol, Phenytoin, Metronidazole, Dapsone etc.) Toxin (As ,OPC, Pb ,Hg except alcohol) etc.; 3. Patients refuse to participate.；

研究者信息

研究负责人姓名

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试验机构

Dr. Nayema Masrura

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

4203

联系人通讯地址