Effect of Nigella Sativa plant on allergic rhinitis in children 3 to 15 years old
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 50 patients. Random number table will used for randomization.
Settings and conduct
The study site was the children's ward of Amirkola Hospital in Babol. The study population consisted of 50 samples. No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 3 to 15 years old; with allergic rhinitis; no consumption of steroids, antihistamines and decongestants during 2 weeks before the study. Non inclusion criteria: Patients with chronic lung diseases other than allergic rhinitis, heart disease, kidney disease, metabolic disorders, malnutrition patients, previous allergy to black seed.
Intervention groups
Intervention group: This group receives standard treatment (including corticosteroid nasal spray, montazone, antihistamine, anti-leukotriene) and Rasa Synx nasal spray (black seed extract, made in Iran). Control group: This group receives only standard treatment.
Main outcome variables
IgE of serum and nasal secretion, Eosinophil count of serum and nasal secretion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220411054489N1
Registration date:2022-05-29, 1401/03/08
Registration timing:prospective
Last update:2022-05-29, 1401/03/08
Update count:0
Registration date
2022-05-29, 1401/03/08
Registrant information
Name
Payam Payandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 314 8922
Email address
p.payandeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-06, 1401/03/16
Expected recruitment end date
2022-09-07, 1401/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of the spray effect of Nigella Sativa plant on allergic rhinitis in children 3 to 15 years old
Public title
The efficacy of Black seed spray in the treatment of Nasal allergic inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 3-15 years with allergic rhinitis
No consumption of steroids, antihistamines and decongestants during 2 weeks before the study
Exclusion criteria:
Patients with chronic lung diseases other than allergic rhinitis
Heart disease
Kidney disease
Metabolic disorders
Malnutrition patients
Previous allergy to black seed
Age
From 3 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After blocking, the samples are randomly divided into two groups of 25 using the table of random numbers in the intervention and control groups.The randomization unit is individual. The size of the blocks is 4 and in each block, each intervention group will be repeated twice. Sequences of size 4 will then be generated using Sealedenvelop.com ¬ software. Using this randomly generated list, participants are assigned to one of two study groups. To hide the random allocation list, a special code will be assigned to each of the intervention groups that even the main executor of the project (supervisor) is not aware of. These codes are written on a piece of paper and placed in a sealed envelope. A unique code that is specific to each patient will be written on this paper as well as its envelope. All envelopes are placed in a larger box in random order and will be sealed in the box. The main researcher, after reviewing the inclusion criteria and obtaining informed consent, as well as registering the patient's details in a special form, with the cooperation of the random allocation list (this person is an expert other than the main researcher involved in the disease recruitment process And the sample is entered) is called and the patient is randomized.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Approval date
2022-03-07, 1400/12/16
Ethics committee reference number
IR.MUBABOL.HRI.REC.1400.245
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.4
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
IgE of serum and nasal secretion
Timepoint
At first and one month later
Method of measurement
Laboratory test
2
Description
Eosinophil count of serum and nasal secretion
Timepoint
At first and one month later
Method of measurement
Laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes a puff of corticosteroid montazone nasal spray every 12 hours with an antihistamine (neotadine tablet or syrup) adjusted by weight, and an anti-leukotriene (5 to 10 mg daily by Montelocast depending on age) and Rasa Synx nasal spray (black seed extract, made in Iran) one puff every twelve hours on each side of the nose (for three weeks).
Category
Treatment - Drugs
2
Description
Control group: Includes corticosteroid montazone nasal spray, one puff every 12 hours, antihistamine (neotadine tablet or syrup) adjusted by weight, and anti-leukotriene (Montelukast 5 or 10 mg daily, 1 depending on age).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kola Babol Children's Hospital
Full name of responsible person
Dr. Payam Payandeh
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 2153
Email
p.payandeh@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajabian
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3219 7667
Email
ramazan@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Taghizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 2153
Email
dr.taghizadehfatemeh15@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Payam Payandeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 2153
Email
p.payandeh@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Payam Payandeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 2153
Email
p.payandeh@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information is confidential on the basis of a contract between the executor and the patients.