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Comparison of therapeutic efficacy of topical corticosteroid and oral zinc sulfate-topical corticosteroid combination in the treatment of vitiligo patients: a randomized clinical trial
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注册号:

Registration number:

ChiCTR-TRC-10000930 

最近更新日期:

Date of Last Refreshed on:

2015-06-14 

注册时间:

Date of Registration:

2010-06-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Comparison of therapeutic efficacy of topical corticosteroid and oral zinc sulfate-topical corticosteroid combination in the treatment of vitiligo patients: a randomized clinical trial 

Public title:

Comparison of therapeutic efficacy of topical corticosteroid and oral zinc sulfate-topical corticosteroid combination in the treatment of vitiligo patients: a randomized clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

vitiligo and zinc 

Scientific title:

vitiligo and zinc 

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:

Nooshin Bagherani 

研究负责人:

Reza Yaghoobi 

Applicant:

Nooshin Bagherani 

Study leader:

Reza Yaghoobi 

申请注册联系人电话:

Applicant telephone:

+98 0918 8636512 

研究负责人电话:

Study leader's telephone:

+98 0916 1186021 

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:

nooshinbagherani@Yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

yaghoobi_rz@yahoo.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:

Department of Dermatology, Emam Khomeini Hospital, 61335 

研究负责人通讯地址:

Department of Dermatology, Emam Khomeini Hospital, 61335 

Applicant address:

Department of Dermatology, Emam Khomeini Hospital, 61335 

Study leader's address:

Department of Dermatology, Emam Khomeini Hospital, 61335 

申请注册联系人邮政编码:

Applicant postcode:

61335 

研究负责人邮政编码:

Study leader's postcode:

61335 

申请人所在单位:

Reza Yaghoobi 

Applicant's institution:

Reza Yaghoobi 

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:

D/187 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

The ethic committee of Jundishapour University of Medical Sciences, Ahvaz, Iran. 

Name of the ethic committee:

The ethic committee of Jundishapour University of Medical Sciences, Ahvaz, Iran. 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-02-21 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

Jundishapour University of Medical Sciences, Ahvaz, Iran 

Primary sponsor:

Jundishapour University of Medical Sciences, Ahvaz, Iran 

研究实施负责(组长)单位地址:

Jundishapour University of Medical Sciences, Ahvaz, Iran 

Primary sponsor's address:

Jundishapour University of Medical Sciences, Ahvaz, Iran 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

Iran

省(直辖市):

Ahvaz

市(区县):

Country:

Iran

Province:

Ahvaz

City:

单位(医院):

Jundishapour University of Medical Sciences, Ahvaz, Iran

具体地址:

Jundishapour University of Medical Sciences, Ahvaz, Iran

Institution
hospital:

Jundishapour University of Medical Sciences, Ahvaz, Iran

Address:

Jundishapour University of Medical Sciences, Ahvaz, Iran

经费或物资来源:

Jundishapour University of Medical Sciences, Ahvaz, Iran 

Source(s) of funding:

Jundishapour University of Medical Sciences, Ahvaz, Iran 

研究疾病:

Vitiligo 

Target disease:

Vitiligo 

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:

上市后药物 

Study phase:

研究目的:

The purposes of this study were to evaluate the efficacy of supplemental zinc on the treatment of vitiligo. 

Objectives of Study:

The purposes of this study were to evaluate the efficacy of supplemental zinc on the treatment of vitiligo. 

药物成份或治疗方案详述:

Corticosteroid 0.05% clobetasol propionate cream in isopropyl alcohol 65o preparation (in equal pro 

Description for medicine or protocol of treatment in detail:

Corticosteroid 0.05% clobetasol propionate cream in isopropyl alcohol 65o preparation (in equal pro 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

Any ageAny gender The localized and gneralized types of vitiligo with exception of segmental one (with involvement <20% of body surface)Vitiligo duration less than 5 yearsNegative history of systemic disorderNo pregnancyNegative history of drug administrationNormal or low serum zincNormal other laboratory testsTaking no zinc during 4 weeks prior to referring 

Inclusion criteria

Any ageAny gender The localized and gneralized types of vitiligo with exception of segmental one (with involvement <20% of body surface)Vitiligo duration less than 5 yearsNegative history of systemic disorderNo pregnancyNegative history of drug administrationNormal or low serum zincNormal other laboratory testsTaking no zinc during 4 weeks prior to referring 

排除标准:

The segmental and universal types of vitiligo Positve history of systemic disorder Pregnancy Positive history of drug administration High serum zinc Abnormal other laboratory tests Taking zinc during 4 weeks prior to referring 

Exclusion criteria:

The segmental and universal types of vitiligo Positve history of systemic disorder Pregnancy Positive history of drug administration High serum zinc Abnormal other laboratory tests Taking zinc during 4 weeks prior to referring 

研究实施时间:

Study execute time:

From2008-03-01To 2009-03-01 

干预措施:

Interventions:

组别:

A

样本量:

16

Group:

A

Sample size:

干预措施:

topical corticosteroid as 0.05% clobetasol propionate cream in isopropyl alcohol 65o preparation (in equal proportion) for the body and 0.1% triamcinolone acetonide cream for the face and flexures, two times daily

干预措施代码:

Intervention:

topical corticosteroid as 0.05% clobetasol propionate cream in isopropyl alcohol 65o preparation (in equal proportion) for the body and 0.1% triamcinolone acetonide cream for the face and flexures, two times daily

Intervention code:

组别:

B

样本量:

16

Group:

B

Sample size:

干预措施:

topical corticosteroid (compatible with the first group) admixed with oral zinc sulfate (220-mg capsule) in dose of 2 capsules per day in teenager and adults and 10mg/kg of capsule or syrup for children;. For the second group, serum zinc level was repeatedly measured 1 and 3 months after commencing the treatment.

干预措施代码:

Intervention:

topical corticosteroid (compatible with the first group) admixed with oral zinc sulfate (220-mg capsule) in dose of 2 capsules per day in teenager and adults and 10mg/kg of capsule or syrup for children;. For the second group, serum zinc level was repeatedly measured 1 and 3 months after commencing the treatment.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

Iran 

省(直辖市):

Khuzestan-Ahvaz 

市(区县):

 

Country:

Iran 

Province:

Khuzestan-Ahvaz 

City:

 

单位(医院):

Jundishapour University of Medical Sciences 

单位级别:

NA 

Institution
hospital:

Jundishapour University of Medical Sciences  

Level of the institution:

NA 

国家:

Iran 

省(直辖市):

Khuzestan-Ahvaz 

市(区县):

 

Country:

Iran 

Province:

Khuzestan-Ahvaz 

City:

 

单位(医院):

Emam Khomeini Hospital 

单位级别:

NA 

Institution
hospital:

Emam Khomeini Hospital  

Level of the institution:

NA 

测量指标:

Outcomes:

指标中文名:

Physical Examination

指标类型:

主要指标 

Outcome:

Physical Examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Vitiligo data

指标类型:

主要指标 

Outcome:

Vitiligo data

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

The results of treatment

指标类型:

主要指标 

Outcome:

The results of treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Past history

指标类型:

主要指标 

Outcome:

Past history

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Demographic data

指标类型:

主要指标 

Outcome:

Demographic data

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Data of the two study groups

指标类型:

主要指标 

Outcome:

Data of the two study groups

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Laboratory test

指标类型:

主要指标 

Outcome:

Laboratory test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 11 years
最大 Max age 59 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):

random number table

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

random number table

盲法:

1: not blinding

Blinding:

1: not blinding

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

Department of Dermatology, Jundishapour University of Medical Sciences, Emam Khomeini Hospital

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

Department of Dermatology, Jundishapour University of Medical Sciences, Emam Khomeini Hospital

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:

Department of Dermatology, Jundishapour University of Medical Sciences, Emam Khomeini Hospital

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

Department of Dermatology, Jundishapour University of Medical Sciences, Emam Khomeini Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-06-24
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