Comparison of the effect of budesonide and Rasasinex on the control of allergic rhinitis symptoms
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 100 patients.
Settings and conduct
1-place of the study: The lung and allergy clinic of Baqiyatallah Hospital in Tehran.
2-blinding: Medicines are prepared in the same packaging and appearance and size. Then they are coded based on codes already prepared using random numbers table
The list of codes for each drug will remain with one of the executors until the end of the study. On drugs, numerical codes from 1 to 100 are recorded and patients receive drug no. 1 to 100 after entering the study, respectively. When analyzing the data, the code enforcers will provide the data analyzer in the form of A or B, so the study will be done in double-blind form.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all adults more than 18 years old; mild to moderate allergic rhinitis.
Non-inclusion: allergy to black seed products and olive oil; active nasal bleeding; acute bronchitis; upper respiratory tract infection; pneumonia.
Intervention groups
Intervention group 1: budesonide spray recipient. Intervention group 2: Rasasinex spray recipient.
Main outcome variables
Symptoms of congestion and nasal congestion and the extent to which these symptoms resolve; Sleep disorder; Disorders in daily activities, leisure or exercise; Disruption in work and school affairs; Painful symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110614006804N2
Registration date:2021-01-15, 1399/10/26
Registration timing:registered_while_recruiting
Last update:2021-01-15, 1399/10/26
Update count:0
Registration date
2021-01-15, 1399/10/26
Registrant information
Name
Mohammad Javad Behzadnia
Name of organization / entity
Baghyatallah medical sciences university
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2012
Email address
behzadnia@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-17, 1399/09/27
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Budesonide and Rasa Sinex nasal sprays on control of allergic rhinitis patients
Public title
Budesonide and Rasa Sinex effects on allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with allergic rhinitis who are confirmed by the clinical immunologist or Otolaryngologist
Exclusion criteria:
History of Asthma
Acute bacterial sinusitis
Recent topical or systemic Corticosteroid treatment
Severe polyposis in rhino-endoscopy
allergy to the black seeds and olive oil
active nasal bleeding
acute bronchitis
pneumonia
upper respiratory tract infection
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
First, the medicines are prepared in the same packaging and appearance and size. Then they are coded based on codes already prepared using random numbers table.
Randomization method: Permuted block randomization is done so that first all blocks of size 4 containing two codes A and B are prepared and then random blocks are selected by placement using random numbers table (25 blocks). These blocks form a sequence of 100 codes A and B, each of which is randomly assigned to one of the groups. The list of codes for each drug will remain with one of the executors until the end of the study. Numerical codes from 1 to 100 are recorded on drugs, and patients receive drug no. 1 to 100 after entering the study, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, first of all, we explain the patients about the random allocation in one of the two routine treatment. Then, according to the simple randomized method, they will put in group A or B. According to this, one of the drugs that are completely similar and only tagged as A, B will be prescribed for him/her.
Placebo
Not used
Assignment
Parallel
Other design features
none
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah hospital
Street address
Trauma Research Center; Baqiyatallah University of Medical Sciences; Nosrati alley; Sheikh Bahaie street; Molla Sadra street; Vanaq square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-12-17, 1399/09/27
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.043
Health conditions studied
1
Description of health condition studied
Allergy
ICD-10 code
J30.1
ICD-10 code description
Allergic rhinitis due to pollen
2
Description of health condition studied
Allergy
ICD-10 code
J30.2
ICD-10 code description
Other seasonal allergic rhinitis
Primary outcomes
1
Description
Allergic symptoms severity score based on the European Standard Allergy Questionnaire (ECRHS SCREENING QUESTIONNAIRE)
Timepoint
day 0 and day30.
Method of measurement
we will use the Demographic information and symptom severity questionnaire based on the European Standard Allergy Questionnaire (ECRHS SCREENING QUESTIONNAIRE), a validated sample of which is used in Persian.
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group is consisted of people who receive Rasa sinex spray. This spray is made by Artiman Company, contain olive oil and black seeds extract. The patient should use the drug twice a day every 12 hours in the nose for one month.
Category
Treatment - Drugs
2
Description
The second intervention group is consisted of those who receive Budesonide spray. This spray is manufactured by Cipla India company, named Naxonella, contain 0.5 mg/2 cc of inhaled glucocorticoids. The patient should use the drug twice a day every 12 hours in the nose for one month.
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After deleting the patient's identification data; data sharing could be possible.
When the data will become available and for how long
Immediately after the result publication.
To whom data/document is available
Only for academic and research requesting
Under which criteria data/document could be used
After researcher's request assessment, it could be possible for sharing the data.
From where data/document is obtainable
Via the corresponding author of the research.
What processes are involved for a request to access data/document
First of all a requesting email should send for the corresponding author;after the confirmation of the sender identity and his/her goal, we could share the data.