Study the effect of the product contains Black Seed on the bigger stones or equal to five millimetres in patients with kidney stones without metabolic or infectious risk factors.
The purpose of this study was to investigate the effect of Nigella sativa on kidney stone dissolving.
Design
In this research, 60 eligible patients with a history of kidney stone equal or larger than to 5 mm diameter on kidney ultrasonography were randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participant.
Settings and conduct
We designed a randomized, double arm, double blind, placebo-controlled clinical trial. This study was carried out in urology clinic of Ghaem and Imam Reza Hospital, affiliated to Mashhad University of Medical Sciences, Iran, from November 2015 to May 2016.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Men and women aged 20 to 60 years, people 20-60 years old with kidney stone disease that has been confirmed by ultrasound sonography. They should have kidney stones equal or larger than 5 mm.
Exclusion criteria : Breast feeding, pregnancy, any renal disorder which requires new treatment protocols and known allergy to black seed.
Intervention groups
Eligible patients were divided into two groups. Patients were randomly assigned to receive either a 10 weeks black seed capsules (500 mg 2 times per day) as the intervention group, or placebo capsules (500 mg 2 times per day) as the control group.
Main outcome variables
The primary outcome measure in this trial was change in the size of renal stones by using ultrasound sonography. Secondary outcome measures were changes in the levels of serum calcium and urine PH.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160619028530N2
Registration date:2018-02-20, 1396/12/01
Registration timing:retrospective
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Mohamad Reza Ardakani Movaghati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8342
Email address
ardakanimr1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
personal- medical university of Mashhad
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2016-02-20, 1394/12/01
Actual recruitment end date
2016-10-16, 1395/07/25
Trial completion date
empty
Scientific title
Study the effect of the product contains Black Seed on the bigger stones or equal to five millimetres in patients with kidney stones without metabolic or infectious risk factors.
Public title
Efficacy of black seed (Nigella sativa) on kidney stone dissolving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 20 to 60 years, people 20-60 years old with kidney stone disease that has been confirmed by ultrasound sonography
Patients with kidney stones equal or larger than 5 mm diameter
People who do not have poor renal and hepatic function (according to tests and records)
people who are satisfied with traditional treatment
Exclusion criteria:
pregnancy
breast feeding
any renal disorder which requires new treatment protocols
known allergy to black seed
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Actual sample size reached:
53
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
1- Use coded questionnaires
2- The use of similar drug packs in both intervention and control groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Building Ghoreshi., Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177501365
Approval date
2016-02-13, 1394/11/24
Ethics committee reference number
IR.MUMS.REC.1394.659
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
Stone number
Timepoint
Before the intervention and 70 days after the start of taking the black seed
Method of measurement
Change in the number of stones after intervention by kidney ultrasound based on millimetres.
2
Description
Stone size
Timepoint
Before the intervention and 70 days after the start of taking the black currant.
Method of measurement
Change in the size of the stones after the intervention by kidney ultrasound based on millimetres.
Secondary outcomes
1
Description
The amount of calcium in the blood
Timepoint
Before the intervention and 70 days after the start of taking the black seed.
Method of measurement
Photometric
2
Description
Ph level of urine
Timepoint
Before the intervention and 70 days after the start of taking the black seed
Method of measurement
pH meter
Intervention groups
1
Description
Intervention group: Capsules of black seed (500 mg twice a day) were given to patients for 10 weeks. Capsules were taken with honey syrup.
Category
Placebo
2
Description
Control group: Placebo capsules (500 mg twice a day) were given to patients for 10 weeks. Capsules were taken with honey syrup.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mahdi yousofi
Street address
Central Clinic, Imam Reza Hospital, Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Yousofim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Booali Square, Bouali Research Center, Drug Growth Center of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177501365
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Reza Ardakani Movaghati
Position
Traditional Medicine Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional medicine clinic, Imam Reza Hospital, Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3032
Fax
Email
ardakanimr1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional Medicine clinic, Imam Reza Hospital, Bahar street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3032
Fax
Email
Yousofim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Reza Ardakani Movaghati
Position
Traditional Medicine Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional Medicine Clinic, Imam Reza Hospital, Bahar street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3032
Fax
Email
ardakanimr1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available