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

Registration number：

 ChiCTR2100049126 

最近更新日期：

Date of Last Refreshed on：

 2021-07-21 04:16:19 

注册时间：

Date of Registration：

 2021-07-21 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Dr. Nayema Masrura 

研究负责人：

Dr. Nayema Masrura 

Applicant：

Dr. Nayema Masrura 

Study leader：

Dr. Nayema Masrura 

申请注册联系人电话：

Applicant telephone：

 +88 018 17743838

研究负责人电话：

Study leader's
telephone：

+88 018 17743838

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 nayemam@outlook.com

研究负责人电子邮件：

Study leader's E-mail：

 nayemam@outlook.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Panchlaish, Chittagong, Bangladesh

研究负责人通讯地址：

K B fazlul Kader Road, Panchlaish.

Applicant address：

Panchlaish, Chittagong, Bangladesh

Study leader's address：

K B fazlul Kader Road, Panchlaish.

申请注册联系人邮政编码：

Applicant postcode：

 4203

研究负责人邮政编码：

Study leader's postcode：

 4203

申请人所在单位：

孟加拉国热带病与传染病研究所

Applicant's institution：

Assistant Surgeon, Bangladesh Institute of Tropical and Infectious Diseases (BITID), Foujdehat, chittagong, Bangladesh

研究负责人所在单位：

孟加拉国热带病与传染病研究所

Affiliation of the Leader：

Assistant Surgeon, Bangladesh Institute of Tropical and Infectious Diseases (BITID), Foujdehat, chittagong, Bangladesh

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 CMC/PG/2018/472

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Ethical Committee,Chittagong Medical College

Name of the ethic committee：

Ethical Committee,Chittagong Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-11-10 00:00:00

伦理委员会联系人：

Professor Dr M A Sattar

Contact Name of the ethic committee：

Professor Dr M A Sattar

伦理委员会联系地址：

K B Fazlul Kader Road,Panchlaish, Chittagong, Bangladesh

Contact Address of the ethic committee：

K B Fazlul Kader Road,Panchlaish, Chittagong, Bangladesh

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Dr. Nayema Masrura

Primary sponsor：

Dr. Nayema Masrura

研究实施负责（组长）单位地址：

K B fazlul Kader Road, Panchlaish, Chittagong, Bangladesh

Primary sponsor's address：

K B fazlul Kader Road, Panchlaish, Chittagong, Bangladesh

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

孟加拉

省(直辖市)：

Chittagong

市(区县)：

Chittagong

Country：

Bangladesh

Province：

Chittagong

City：

Chittagong

单位(医院)：

Chittagong Medical College

具体地址：

K B fazlul Kader Road, Panchlaish.

Institution
hospital：

Chittagong Medical College

Address：

K B fazlul Kader Road, Panchlaish.

经费或物资来源：

self funding

Source(s) of funding：

self funding

研究疾病：

dry beriberi  

Target disease：

dry beriberi

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

单臂 

Study design：

Single arm 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

In our day to day clinical practice we have encountered many of them with neurological complaints mimicking thiamine deficiency (TD). Investigations to confirm this condition are not available in our setting. So, the diagnosis of TD in such contexts is a real challenge and a high level of clinical suspicion should be demonstrated in such situations. Early treatment with thiamine has the potential to rapidly reverse clinical signs and minimize sequelae, before the onset of fixed lesions. The lack of diagnostic capacity in our settings justifies the use of a therapeutic thiamine challenge in cases with high clinical suspicion. However, there is paucity of study about the clinical spectrum and therapeutic response of such patients in Bangladesh. The aim of this prospective hospital based quasi-experimental study is to determine the clinical pattern of patients with suspected dry beriberi and their outcome to thiamine therapeutic challenge in our setting. Fifty-five patients of clinically suspected dry beriberi will be enrolled as per inclusion and exclusion criteria. Then therapeutic trial of Inj. Thiamine is given IV for 1st week (200mg IV daily for peripheral neuropathy and then orally (tab. Thiamin 100mg bd) for 11 weeks. Patients will be followed up after 1, 6 and 12 week to see the response. Pre and post treatment data will be recorded in pre designed case record form. Analysis will be performed with SPSS version 23. Our study result is likely to sensitize the health professionals of this region about this neglected health issue by increasing awareness of the clinical spectrum of TD. Moreover, study may provide the impetus for fashioning national policies on the diagnosis, treatment and prevention of thiamine deficiency disorders in our country. 

Description for medicine or protocol of treatment in detail：

In our day to day clinical practice we have encountered many of them with neurological complaints mimicking thiamine deficiency (TD). Investigations to confirm this condition are not available in our setting. So, the diagnosis of TD in such contexts is a real challenge and a high level of clinical suspicion should be demonstrated in such situations. Early treatment with thiamine has the potential to rapidly reverse clinical signs and minimize sequelae, before the onset of fixed lesions. The lack of diagnostic capacity in our settings justifies the use of a therapeutic thiamine challenge in cases with high clinical suspicion. However, there is paucity of study about the clinical spectrum and therapeutic response of such patients in Bangladesh. The aim of this prospective hospital based quasi-experimental study is to determine the clinical pattern of patients with suspected dry beriberi and their outcome to thiamine therapeutic challenge in our setting. Fifty-five patients of clinically suspected dry beriberi will be enrolled as per inclusion and exclusion criteria. Then therapeutic trial of Inj. Thiamine is given IV for 1st week (200mg IV daily for peripheral neuropathy and then orally (tab. Thiamin 100mg bd) for 11 weeks. Patients will be followed up after 1, 6 and 12 week to see the response. Pre and post treatment data will be recorded in pre designed case record form. Analysis will be performed with SPSS version 23. Our study result is likely to sensitize the health professionals of this region about this neglected health issue by increasing awareness of the clinical spectrum of TD. Moreover, study may provide the impetus for fashioning national policies on the diagnosis, treatment and prevention of thiamine deficiency disorders in our country.  

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2018-07-01 00:00:00至 To 2018-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-11-11 00:00:00 至 To 2018-04-30 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 55

Group：

Case series

Sample size：

干预措施：

Thiamine (intravenous and oral)

干预措施代码：

Intervention：

Thiamine (intravenous and oral)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 孟加拉

省(直辖市)：

 Chittagong 

市(区县)：

  

Country：

Bangladesh

Province：

Chittagong

City：

单位(医院)：

 Chittagong Medical College Hospital 

单位级别：

 三级 

Institution
hospital：

Chittagong Medical College Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Clinical Improvement

指标类型：

主要指标

Outcome：

Clinical Improvement

Type：

Primary indicator

测量时间点：

before treatment and After 1 week, 6 week & 12 week of treatment by Thiamine

测量方法：

Overall Neuropathy Limitation Scale Score

Measure time point of outcome：

before treatment and After 1 week, 6 week & 12 week of treatment by Thiamine

Measure method：

Overall Neuropathy Limitation Scale Score

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

not applicable

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

Randomization Procedure (please state who generates the random number sequence and by what method)：

not applicable

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

not applicable

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

already uploaded

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

already uploaded

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

already uploaded

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

already uploaded

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-07-21 04:16:19
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