Protocol summary

Summary
Aim: Evaluation of effect of Kohlrabi’s juice on urinary concentration of oxalate, calcium, uric acid, citrate and crystals in patients with history of renal stone. Method of study: Randomized, triple blind, controlled with placebo, unit center, stage 2 trial. Inclusion criteria: 1-Prehension of Informed consent for participation in the study 2-Subjects without special disease and disusing of any traditional or industrial drug. 3-Patients with history of recurrent renal stone: within the study and 6-8 weeks before initiation of it, ought not to use drug associated with decreasing recurrence of renal stone and/or superposed as instance of any urologic procedures such as TUL, PCNL & ESWL. 4-Disusing of warfarin drug and vitamin supplements in all groups. 5-Impassibility to Brassica oleracea in all groups. Exclusion criteria: 1-Patient disinclination for continuance of participation in the study. 2-Incidenting of sensitivity or any adverse reaction to utilized drug. Sample size: Intervention group: 37person, and control group: 37person. Interventions: study was designed in two groups; group 1: patients with history of nephrolithiasis (n=37) that receive placebo (vehicle syrup – 10 mg/kg/day for 2 weeks), and group 2: patients with history of nephrolithiasis (n=37) that receive oral drug of “Kohlrabi” (Brassica oleracea gongylodes) (10mg/kg/day for 2 weeks) Duration of intervention: two weeks Primary outcomes: 1-decreasing of urinary concentration of oxalate, calcium, uric acid and citrate. 2- Decreasing of urinary crystals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021028003N2
Registration date: 2017-03-08, 1395/12/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Sanaz Taherpour
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 859 9857
Email address
taherpour.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour university of medical sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-05-21, 1396/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Kohlrabi’s juice on urinary concentration of oxalate, calcium, uric acid, citrate and crystals in patients with history of renal stone.
Public title
Effect of Kohlrabi on prevention of renal stone
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1-Prehension of Informed consent for participation in the study 2-Subjects without special disease and disusing of any traditional or industrial drug. 3-Patients with history of recurrent renal stone: within the study and 6-8 weeks before initiation of it, ought not to use drug associated with decreasing recurrence of renal stone and/or superposed as instance of any urologic procedures such as TUL, PCNL & ESWL. 4-Disusing of warfarin drug and vitamin supplements in all groups. 5-Impassibility to Brassica oleracea in all groups. Exclusion criteria: 1-Patient disinclination for continuance of participation in the study. 2-Incidenting of sensitivity or any adverse reaction to utilized drug.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahwaz Jundishapour university of medical sciences
Street address
Ahwaz Jundishapour university of medical sciences
City
Ahwaz
Postal code
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.AJUS.REC.1395.688

Health conditions studied

1

Description of health condition studied
Renal stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney-Nephrolithiasis NOS-Renal calculus or stone-Staghorn calculus-Stone in kidney

Primary outcomes

1

Description
Urinary concentration of oxalate
Timepoint
0 & 14th days of study
Method of measurement
24-hour urine collection test

2

Description
Urinary concentration of calcium
Timepoint
0 & 14th days of study
Method of measurement
24-hour urine collection test

3

Description
Urinary concentration of uric acid
Timepoint
0 & 14th days of study
Method of measurement
24-hour urine collection test

4

Description
Urinary concentration of citrate
Timepoint
0 & 14th days of study
Method of measurement
24-hour urine collection test

5

Description
urinary crystals
Timepoint
0 & 14th days of study
Method of measurement
24-hour urine collection test

Secondary outcomes

1

Description
Size of renal stone
Timepoint
0 & 14th days of study
Method of measurement
Abdominopelvic CT scan without contrast

2

Description
Serum cratinine
Timepoint
0 & 14th days of study
Method of measurement
Blood test

3

Description
BUN
Timepoint
0 & 14th days of study
Method of measurement
Blood test

4

Description
ALT
Timepoint
0 & 14th days of study
Method of measurement
Blood test

5

Description
AST
Timepoint
0 & 14th days of study
Method of measurement
Blood test

6

Description
Serum calcium
Timepoint
0 & 14th days of study
Method of measurement
Blood test

7

Description
Serum phosphore
Timepoint
0 & 14th days of study
Method of measurement
Blood test

8

Description
Urine PH
Timepoint
0 & 14th days of study
Method of measurement
Urine test

Intervention groups

1

Description
Control group: placebo (vehicle syrup – 10 mg/kg/day for 2 weeks) / patients with history of nephrolithiasis (n=37)
Category
Treatment - Drugs

2

Description
Intervention group: oral drug of “Kohlrabi” (Brassica oleracea gongylodes) (10mg/kg/day for 2 weeks) / patients with history of nephrolithiasis (n=37)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital, Ahwaz Jundishapour University of medical sciences
Full name of responsible person
ُSanaz Taherpour
Street address
Imam Khomeini hospital
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahwaz Jundishapour University of medical sciences
Full name of responsible person
Mr Dianat
Street address
Ahwaz Jundishapour University of medical sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapour University of medical sciences
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
Ahwaz Jundishapour University of medical sciences
Full name of responsible person
Sanaz Taherpour
Position
medical student/ main cooperator
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Ahwaz
Postal code
Phone
-
Fax
Email
Taherpoursanaz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundishapour University of medical sciences
Full name of responsible person
Dinyar Khazaeli
Position
urologist
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Ahwaz
Postal code
Phone
+98 61 3221 6104
Fax
Email
khazaeli_dinyar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jundishapour University of medical sciences
Full name of responsible person
Sanaz Taherpour
Position
Medical student
Other areas of specialty/work
Street address
City
Ahwaz
Postal code
Phone
00
Fax
Email
Taherpoursanaz@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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