Evaluation of Nigella sativa and honey combination effect on kidney stone expulsion in human
Design
randomized clinical trial with control group - parallel groups,
Settings and conduct
A clinical trial will be conducted on 40 eligible patients who will refer to the urology clinic of Dezful Ganjavian Hospital and will be identified by a sonographist that they have kidney stones smaller than 6 mm. They will be randomly assigned to control and treatment groups. The treatment group will take 8 grams of the product with one glass of warm water daily for one month. The control group will not receive medication. Both groups will drink 6-8 glasses of water per day. At the end, sonography will repeat. Blood and urine biochemical test, 24h urine volume and urine pH will determine before and after intervention too. At last the rate of stone expulsion will compare in two groups with SPSS 22 software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:age>18, stone size> 6 mm, Asymptomatic and without hydronephrosis, No need to medication; Exclusion criteria: Pregnancy, History of the complication or sensitivity to black seed, Receiving drugs that affect kidney stones, Use of stone crushing techniques, Diabetes
Intervention groups
Conrol group: Receive 8 glasses of water for one month each day.
Intervention group: Receive 8 glasses of water + 8 grams of product (po) for one month each day
Main outcome variables
Excreted kidney stone number
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111105008013N6
Registration date:2018-11-15, 1397/08/24
Registration timing:retrospective
Last update:2018-11-15, 1397/08/24
Update count:0
Registration date
2018-11-15, 1397/08/24
Registrant information
Name
Amir Siahpoosh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 2197
Email address
siahpoosh-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Nigella sativa and honey combination effect on kidney stone: A clinical Trial
Public title
Nigella sativa and honey effect on kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age>18
stone size> 8 mm
Asymptomatic and without hydronephrosis
No need to medication
Exclusion criteria:
pregnancy
History of the complication or sensitivity to black seed
Receive drugs that affect kidney stones
Use of stone crushing techniques
Diabetes
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
The site of https://www.randomizer.org will be used for simple randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Road
City
ahvaz
Province
Khouzestan
Postal code
6135733184
Approval date
2017-12-02, 1396/09/11
Ethics committee reference number
IR.AJUMS.REC.1396.645
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Excreted kidney stone number
Timepoint
Start of intervention and a month later
Method of measurement
Ultrasonography and blood and urine tests
Secondary outcomes
1
Description
urine volume 24 h
Timepoint
Start of intervention and a month later
Method of measurement
Urine 24 h test by BT-1500 autoanalyser
2
Description
Creatinine in urine 24h
Timepoint
Start of intervention and a month later
Method of measurement
Urine 24h test by Pars Azmoon kit
3
Description
oxalate in urine 24 h
Timepoint
Start of intervention and a month later
Method of measurement
urine 24 h test by Darmankau kit
4
Description
Citrate in urine 24 h
Timepoint
Start of intervention and a month later
Method of measurement
urine 24 h test by Darmankau kit
5
Description
Uric acid in urine 24 h
Timepoint
Start of intervention and a month later
Method of measurement
urine 24h test by Pars Azmoon kit
6
Description
Calcium in urine 24 h
Timepoint
Start of intervention and a month later
Method of measurement
urine 24h test by Pars Azmoon kit
7
Description
Urine specific gravity
Timepoint
Start of intervention and a month later
Method of measurement
Urinalysis by BT-1500 autoanalyser
8
Description
urine pH
Timepoint
Start of intervention and a month later
Method of measurement
Urinalysis by BT-1500 autoanalyser
9
Description
Urine protein
Timepoint
Start of intervention and a month later
Method of measurement
Urinalysis by BT-1500 autoanalyser
10
Description
Urine Cystine
Timepoint
Start of intervention and a month later
Method of measurement
Urinalysis with Spectrophotometer
11
Description
Serum creatinine
Timepoint
Start of intervention and a month later
Method of measurement
Blood test by Pars Azmoon kit
12
Description
Serum calcium
Timepoint
Start of intervention and a month later
Method of measurement
Blood test by Pars Azmoon kit
13
Description
Serum phosphorus
Timepoint
Start of intervention and a month later
Method of measurement
Blood test by BT-1500 autoanalyser
14
Description
Serum uric acid
Timepoint
Start of intervention and a month later
Method of measurement
Blood test by Pars Azmoon kit
15
Description
BUN
Timepoint
Start of intervention and a month later
Method of measurement
Blood test by BT-1500 autoanalyser
16
Description
Stone size
Timepoint
Start of intervention and a month later
Method of measurement
Sonography
Intervention groups
1
Description
Conrol group: Receive 8 glasses of water for one month each day.
Category
Placebo
2
Description
Intervention group: Receive 8 glasses of water + 8 grams of product (po) for one month each day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ganjavian Hospital
Full name of responsible person
Mr. Dr. Eskand Moghimipour
Street address
Dezful
City
Dezful
Province
Khouzestan
Postal code
6461863915
Phone
+98 61 4252 2952
Email
DARMAN@DUMS.AC.IR
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohamad badavi
Street address
Ahvaz- golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 2414
Email
amirsiahpoosh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Laleh Zaheri Abdehvand
Position
Ph.D. student of traditional pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Ph.D traditional pharmacy
Street address
Ahvaz, golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3337 5356
Email
lalehzaheri44@gmil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
فارماکوگنوزی
Street address
Golestan Road - Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Email
lalehzaheri44@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Laleh Zaheri Abdevand
Position
Ph.D. student of traditional pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D. traditional pharmacy
Street address
Golestan Road -
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Email
lalehzaheri44@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data will be shared.
When the data will become available and for how long
Access time is up to 6 months after the results are published
To whom data/document is available
Information will only be available to researchers working in universities and science centers
Under which criteria data/document could be used
Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis.
From where data/document is obtainable
Applicants can be contacted by email with the author to receive the requested data
What processes are involved for a request to access data/document
Applicants will receive the data from the current study by sending an email to the author responsible for a maximum of one month.