Determination the effect of Nigella sativa on Prevention of Neutropenia During Chemotherapy in Children with ALL
Design
In this study, 132 patients with leukemia with inclusion criteria are divided into three intervention groups. Intervention group 1: group under 5 years receive one capsule containing Nigella sativa , Intervention group 2 : The group between5-10years old two capsules containing Nigella sativa and Intervention group 3: group between 10 - 15 years old three capsules containing Nigella sativa .all groups in addition to routine drug receive capsules daily for one months from Barij Essence. After three days the therapeutic effects of the capsule will be assessed and Blood Cells Count checked every week.
Settings and conduct
Clinical trial study Phase 3; Oncology Clinic in shahrekord; Double blind that
the researcher and the patient have no information about the contents of the capsules; Allocated to three intervention groups
Participants/Inclusion and exclusion criteria
Children aged 3 to 15 years With cancer undergoing chemotherapy; no other concomitant diseases
Intervention groups
Intervention group 1: Under 5 years old, in addition to routine medications, receive one capsule containing Nigella sativa daily for one month from Barij Essential Capsules during treatment.
Intervention group 2: The group is five to ten years old who receive two capsules containing Nigella sativa daily for one month in addition to routine medications from Barij Essential during treatment.
Intervention group 3: The group is ten to fifteen years old in addition to routine medications three capsules containing Nigella sativa daily for one month from Barij Essential Capsules during treatment.
Main outcome variables
Complete Blood Count(neutrophils)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191009045035N1
Registration date:2019-12-27, 1398/10/06
Registration timing:registered_while_recruiting
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
kiavash fekri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
fekri@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nigella sativa seed administration on decreasing of White Blood Cells during chemotherapy among children with ALL
Public title
Effect of Nigella sativa seed administration on prevention of neutropenia during chemotherapy among children with blood cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 3 to 15 yearsWith cancer undergoing chemotherapy
No other concomitant diseases
Exclusion criteria:
Congenital or acquired immunodeficiency
Drug Sensitivity
Age
From 3 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The nigella sativa powder produced in capsuls with the same shape and color, and will be coded by the pharmacist, and the codes will be provided only to the supervisor, so that the researcher and the research units will be coded Will be aware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.SKUMS.REC.1397.258
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
Complete Blood Count
Timepoint
every week
Method of measurement
sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Under 5 years old in addition to routine medications, receive one capsule containing Nigella sativa daily for one month from Barij Essence Capsules containing Nigella sativa during treatment.
Category
Prevention
2
Description
Intervention group 2: The group is five to ten years old who receive two capsules containing Nigella sativa daily for one month in addition to routine medications from Barij Essential during treatment.
Category
Prevention
3
Description
Intervention group 3: The group is ten to fifteen years old in addition to routine medications three capsules containing Nigella sativa daily for one month from Barij Essence Capsules during treatment.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Kiavash Fekri
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
fekri@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Kamal Solati
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Deputy of Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Kiavash Fekri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
fekri@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kiavash Fekri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
0098383220016
Email
fekri@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kiavash Fekri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
fekri@skums.ac.ir
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
Total data in article format
When the data will become available and for how long
one years
To whom data/document is available
researchers
Under which criteria data/document could be used
publication
From where data/document is obtainable
journals
What processes are involved for a request to access data/document