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Nooshin Bagherani: please contact us to submit the approval letter of IRB Carboxytherapy efficacy in skin aging
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注册号：

Registration number：

 ChiCTR2200055185 

最近更新日期：

Date of Last Refreshed on：

 2023-01-15 22:53:41 

注册时间：

Date of Registration：

 2022-01-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Nooshin Bagherani: please contact us to submit the approval letter of IRB Carboxytherapy efficacy in skin aging

Public title：

Carboxytherapy efficacy in skin aging

注册题目简写：

English Acronym：

CESA

研究课题的正式科学名称：

Evaluation of carboxytherapy efficacy in skin aging through clinical and ultrasonographic assessments of skin, and pathological, immunohisochemical, and molecular studies of cutaneous status of collagen, elastin, and angiogenic factors

Scientific title：

Evaluation of carboxytherapy efficacy in skin aging through clinical and ultrasonographic assessments of skin, and pathological, immunohisochemical, and molecular studies of cutaneous status of collagen, elastin, and angiogenic factors

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：

Gholamreza Tavoosidana 

Applicant：

Nooshin Bagherani 

Study leader：

Gholamreza Tavoosidana 

申请注册联系人电话：

Applicant telephone：

 00989165828461

研究负责人电话：

Study leader's
telephone：

00989928686167

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：

 g-tavoosi@tums.ac.ir

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：

Taleghani Street, Arak, Iran

研究负责人通讯地址：

Tehran, Iran

Applicant address：

Taleghani Street, Arak, Iran

Study leader's address：

Tehran, Iran

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

伊朗德黑兰医学科学大学

Applicant's institution：

Department of Molecular Medicine, School of Advanced Medical Technologies, Tehran University of Medical Sciences

研究负责人所在单位：

伊朗德黑兰医学科学大学

Affiliation of the Leader：

Department of Molecular Medicine, School of Advanced Medical Technologies, Tehran University of Medical Sciences

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：

 IR.TUMS.MEDICINE.REC.1400.1077

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：

Ethic Committee of School of Medicine, Tehran University of Medical Sciences

Name of the ethic committee：

Ethic Committee of School of Medicine, Tehran University of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Ethic Committee of School of Medicine, Tehran University of Medical Sciences

Contact Name of the ethic committee：

Ethic Committee of School of Medicine, Tehran University of Medical Sciences

伦理委员会联系地址：

Ghods Shahrak, between south Falamak and Zarafshan, Simaye Iran street, Block A, the 13 th floor

Contact Address of the ethic committee：

Ghods Shahrak, between south Falamak and Zarafshan, Simaye Iran street, Block A, the 13 th floor

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：

Tehran University of Medical Sciences

Primary sponsor：

Tehran University of Medical Sciences

研究实施负责（组长）单位地址：

Enghelab, Tehran, Iran

Primary sponsor's address：

Enghelab, Tehran, Iran

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

伊朗

省(直辖市)：

德黑兰

市(区县)：

Country：

Iran

Province：

Tehran

City：

Tehran

单位(医院)：

德黑兰医学科学大学

具体地址：

Number 3, Keshavarz Street, Between Daneshgh Square and Jannat Abad, Simon Boluivard, The end of Sattary Highway

Institution
hospital：

Nike Fanavaran Plasma

Address：

Number 3, Keshavarz Street, Between Daneshgh Square and Jannat Abad, Simon Boluivard, The end of Sattary Highway

经费或物资来源：

By company

Source(s) of funding：

By company

研究疾病：

Skin aging  

Target disease：

Skin aging

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

In the current study, we assess the efficacy of carboxytherapy in skin aging through clinical, ultrasonographic, pathological, immunohistochemical, and molecular studies.  

Objectives of Study：

In the current study, we assess the efficacy of carboxytherapy in skin aging through clinical, ultrasonographic, pathological, immunohistochemical, and molecular studies.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Active skin infections at the site of biopsy;
2. Connective tissue diseases or genodermatoses;
3. Keloid tendency;
4. Any systemic disorder such as diabetes mellitus, kidney diseases, cardiac diseases, respiratory diseases, liver diseases, severe anemia, etc.
5. Medication (also including supplementary agents) within 6 weeks before the study initiation
6. Any antiaging treatment or procedure at the site of study within one year before study initiation;
7. Cigarette smoking and alcohol and drug abusing;
8. Pregnancy;
9. Breast feeding.

Exclusion criteria：

1. Active skin infections at the site of biopsy;
2. Connective tissue diseases or genodermatoses;
3. Keloid tendency;
4. Any systemic disorder such as diabetes mellitus, kidney diseases, cardiac diseases, respiratory diseases, liver diseases, severe anemia, etc.
5. Medication (also including supplementary agents) within 6 weeks before the study initiation
6. Any antiaging treatment or procedure at the site of study within one year before study initiation;
7. Cigarette smoking and alcohol and drug abusing;
8. Pregnancy;
9. Breast feeding.

研究实施时间：

Study execute time：

从 From 2021-12-23 00:00:00至 To 2022-11-23 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-12-23 00:00:00 至 To 2022-09-23 00:00:00

干预措施：

Interventions：

组别：

Case for clinical, ultrasonographic,pathological, immunohistochemical, and PCR studies

样本量：

 15

Group：

Case for clinical, ultrasonographic,pathological, immunohistochemical, and PCR studies

Sample size：

干预措施：

Carboxytherapy

干预措施代码：

Intervention：

Carboxytherapy

Intervention code：

组别：

Case for Clinical, Ultrasonographic, and Western blotting studies

样本量：

 15

Group：

Case for Clinical, Ultrasonographic, and Western blotting studies

Sample size：

干预措施：

No

干预措施代码：

Intervention：

Non

Intervention code：

组别：

Control

样本量：

 30

Group：

Control

Sample size：

干预措施：

No

干预措施代码：

Intervention：

Non

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 伊朗

省(直辖市)：

 Markazi 

市(区县)：

 Iran 

Country：

Iran

Province：

Markazi

City：

Iran

单位(医院)：

 Vali-Asr Hospital 

单位级别：

  

Institution
hospital：

Vali-Asr Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Effectiveness of carboxytherapy in skin aging in clinical view

指标类型：

主要指标

Outcome：

Effectiveness of carboxytherapy in skin aging in clinical view

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Effectiveness of carboxytherapy in skin aging in pathological view

指标类型：

主要指标

Outcome：

Effectiveness of carboxytherapy in skin aging in pathological view

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Effectiveness of carboxytherapy in skin aging in immunohistochemical view

指标类型：

主要指标

Outcome：

Effectiveness of carboxytherapy in skin aging in immunohistochemical view

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Effectiveness of carboxytherapy in skin aging in ultrasonographic view

指标类型：

主要指标

Outcome：

Effectiveness of carboxytherapy in skin aging in ultrasonographic view

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Effectiveness of carboxytherapy in skin aging in molecular view

指标类型：

主要指标

Outcome：

Effectiveness of carboxytherapy in skin aging in molecular view

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：

标本中文名：

skin

组织：

Sample Name：

Skin

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 60 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）：

In each case, abdominal wall will be symmetrically divided into 2 sides, namely right and left. Carboxytherapy will be performed on one side (case group), and the other side is left without therapy (control group). The case and control groups in each case are selected randomly by falling a coin.

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

In each case, abdominal wall will be symmetrically divided into 2 sides, namely right and left. Carboxytherapy will be performed on one side (case group), and the other side is left without therapy (control group). The case and control groups in each case are selected randomly by falling a coin.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Not stated

Blinding：

Not stated

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

Through publishing in a PubMed-indexed journals

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

Through publishing in a PubMed-indexed journals

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：

Through visiting the subjects and clinical, ultrasonographic, pathological, pathological, immunohistochemical, and molecular studies

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

Through visiting the subjects and clinical, ultrasonographic, pathological, pathological, immunohistochemical, and molecular studies

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-01-02 06:53:16
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