Protocol summary

Summary
Aim of this study: Effectivness of Levisticum officinale on urine cystine of patients with cystinuria admitted in Alzahra hospital in 2013-2014. Convenient sampling method. Not blinded. Placebo not used. Single arm study. An exploratory trial. Inclusion Criteria: Patients with cystinuria admitted in Alzahra hospital in 2013-2014; Obtaining written informed consent. Exclusion criteria: Not having any agreement to participate or continue the study; Any probable complications. Sample size is 18 patients. Intervention is consumption of one tablespoon, two times a day in cystinuria patients for two weeks. Way of consumption is one tablespoon in the morning and one in the evening. Studied consequence is effectiveness of Lovage(Levisticum Officinale)on urine cystine in cystinuric patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013061213655N1
Registration date: 2015-06-23, 1394/04/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-23, 1394/04/02
Registrant information
Name
Mehrdad Mohammadi Sichani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3624 9031
Email address
m_mohammadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Isfahan Medical Faculty, Isfahan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectivness of Levisticum officinale on Urine Cystine of Patients with Cystinuria admitted in Alzahra hospital in 2013-2014
Public title
Effectiveness of Lovage(Levisticum Officinale)in prevention of formation of cystin stones
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with cystinuria admitted in Alzahra hospital in 2013-2014; Obtaining written informed consent. Exclusion criteria: Not having any agreement to participate or continue the study ; Any probable complications.
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Medical Faculty
Street address
Isfahan Medical Faculty, Isfahan University of Medical Sciences, Hezarjarib St, Azadi Sq, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
393023

Health conditions studied

1

Description of health condition studied
Cystinuria
ICD-10 code
E72.0
ICD-10 code description
Disorders of amino-acid transport

Primary outcomes

1

Description
Urine cystine
Timepoint
Before consumption of Lovage and after 2 weeks consumption of Lovage
Method of measurement
Collection of 24 hours urine

Secondary outcomes

1

Description
Level of creatinin in 24 hours urine.Volume of 24 hours urine
Timepoint
Before consumption of Lovage and after two weeks consumption of Lovage
Method of measurement
Collection of 24 hours urine

Intervention groups

1

Description
Consumption of one tablespoon of Lovage,two times a day ,for two weeks of period.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Mehrdad Mohammadi Sichani
Street address
Isfahan, Alzahra Hospital, Urology center
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Adjutancy of Isfahan Medical Faculty
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan Medical Faculty, Isfahan University of Medical Sciences, Hezarjarib St, Azadi Sq, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
393023
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Adjutancy of Isfahan Medical Faculty
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehrdad Mohammadi Sichani
Position
Assistant Professor at Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Urology center, Alzahra Hospital, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
m_mohammadi@med.mui.ac.ir
Web page address
drmmohammadi.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehrdad Mohammadi Sichani
Position
Assistant Professor at Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Urology center, Alzahra Hospital, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
m_mohammadi@med.mui.ac.ir
Web page address
drmmohammadi.ir

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Erfan Parvaneh
Position
Medical student at Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
No 100, 7th Alley ,Jaber St, Mardavij St, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3669 0705
Fax
Email
erfanparvaneh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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