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Silodosin as a Medical Expulsive Therapy for Distal Ureteral Stones in the Pakistani Population
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注册号：

Registration number：

 ChiCTR2200060517 

最近更新日期：

Date of Last Refreshed on：

 2022-06-04 08:39:22 

注册时间：

Date of Registration：

 2022-06-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Silodosin as a Medical Expulsive Therapy for Distal Ureteral Stones in the Pakistani Population

Public title：

Silodosin as a Medical Expulsive Therapy for Distal Ureteral Stones in the Pakistani Population

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Silodosin as a Medical Expulsive Therapy for Distal Ureteral Stones in the Pakistani Population

Scientific title：

Silodosin as a Medical Expulsive Therapy for Distal Ureteral Stones in the Pakistani Population

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 Hassan Mumtaz 

研究负责人：

DR Kashif Bangash 

Applicant：

Dr Hassan Mumtaz 

Study leader：

DR Kashif Bangash 

申请注册联系人电话：

Applicant telephone：

 +92 34 45582229

研究负责人电话：

Study leader's
telephone：

+92 320 9559191

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：

 hassanmumtaz.dr@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 hassanmumtaz.dr@gmail.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：

G-9, Markaz, Kashmir Highway Islamabad, Pakistan

研究负责人通讯地址：

House no 447, road C, Phase 3, Bahria Town, Rawalpindi, Pakistan

Applicant address：

G-9, Markaz, Kashmir Highway Islamabad, Pakistan

Study leader's address：

House no 447, road C, Phase 3, Bahria Town, Rawalpindi, Pakistan

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：

巴基斯坦伊斯兰堡KRL Hospital

Applicant's institution：

KRL Hospital

研究负责人所在单位：

巴基斯坦伊斯兰堡KRL Hospital

Affiliation of the Leader：

KRL Hospital

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：

 KRL-HI-ERC/May/16-05

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：

巴基斯坦伊斯兰堡KRL Hospital

Name of the ethic committee：

KRL Hospital Islamabad

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-05-16 00:00:00

伦理委员会联系人：

DR. Omarah Qureshi

Contact Name of the ethic committee：

DR. Omarah Qureshi

伦理委员会联系地址：

G-9, Markaz, Kashmir Highway Islamabad, Pakistan

Contact Address of the ethic committee：

G-9, Markaz, Kashmir Highway Islamabad, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +923445582229

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. Kashif Bangash

Primary sponsor：

Dr. Kashif Bangash

研究实施负责（组长）单位地址：

G-9, Markaz, Kashmir Highway Islamabad, Pakistan

Primary sponsor's address：

G-9, Markaz, Kashmir Highway Islamabad, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

Islamabad Capital Territory

市(区县)：

Islamabad

Country：

Pakistan

Province：

Islamabad Capital Territory

City：

Islamabad

单位(医院)：

KRL Kospital

具体地址：

G-9, Markaz, Kashmir Highway

Institution
hospital：

KRL Kospital

Address：

G-9, Markaz, Kashmir Highway

经费或物资来源：

Nil

Source(s) of funding：

Nil

研究疾病：

Ureteric Stones  

Target disease：

Ureteric Stones

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：

单臂 

Study design：

Single arm 

研究目的：

we aim to determine the efficacy of silodosin drug for treatment of distal ureteric stones.  

Objectives of Study：

we aim to determine the efficacy of silodosin drug for treatment of distal ureteric stones.

药物成份或治疗方案详述：

Silodosin Drug will be given 8mg per oral in the morning once a day 

Description for medicine or protocol of treatment in detail：

Silodosin Drug will be given 8mg per oral in the morning once a day 

纳入标准：

Inclusion criteria

排除标准：

Patients previously taking any medication or any other invasive procedure were excluded from our study. Patients with pyelonephritis, fever, Interactable pain or having creatinine deranged were also excluded from our study.

Exclusion criteria：

Patients previously taking any medication or any other invasive procedure were excluded from our study. Patients with pyelonephritis, fever, Interactable pain or having creatinine deranged were also excluded from our study.

研究实施时间：

Study execute time：

从 From 2021-05-16 00:00:00至 To 2022-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-05-16 00:00:00 至 To 2022-03-31 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 160

Group：

Case series

Sample size：

干预措施：

Silodosin

干预措施代码：

Intervention：

Silodosin

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 Islamabad Capital Territory 

市(区县)：

 Islamabad 

Country：

Pakistan

Province：

Islamabad Capital Territory

City：

Islamabad

单位(医院)：

 KRL Hospital Islamabad 

单位级别：

 Tertiary Hospital 

Institution
hospital：

KRL Hospital Islamabad

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

Stone Free Rate

指标类型：

主要指标

Outcome：

Stone Free Rate

Type：

Primary indicator

测量时间点：

stone expulsion after how many days

测量方法：

USG

Measure time point of outcome：

stone expulsion after how many days

Measure method：

USG

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Stone Size,

Tissue：

Ureter

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 19 岁 years
最大 Max age 76 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）：

Non-Probability Consecutive sampling technique was used

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

Non-Probability Consecutive sampling technique was used

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：

No

Blinding：

No

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）：

No

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

Nill

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：

The data collection was approved by the hospital's ethical committee. Silodosin was prescribed to all patients who came to the urology outpatient department, and their contact information was recorded. Patients were called for follow-up on a weekly basis up to 3 weeks to make sure that the stone was passing through their urine. Record of the exact of day when stone was passed, Size, number, and time of presentation were among the data gathered. Quality of life was recorded before starting the treatment & at the end of treatment

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

The data collection was approved by the hospital's ethical committee. Silodosin was prescribed to all patients who came to the urology outpatient department, and their contact information was recorded. Patients were called for follow-up on a weekly basis up to 3 weeks to make sure that the stone was passing through their urine. Record of the exact of day when stone was passed, Size, number, and time of presentation were among the data gathered. Quality of life was recorded before starting the treatment & at the end of treatment

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-06-04 08:39:22
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