Protocol summary

Study aim
The effect of compound honey syrup on clinical manifestations of chronic sinusitis in cystic fibrosis (CF) patients
Design
This study is a double-blind randomized clinical trial with a sample size of 40 cases.
Settings and conduct
This double-blind study is performed in the lung clinic of Mofid Children's Hospital in Tehran. At the first visit, the relevant questionnaires are completed and the examination is performed by the pulmonary specialist. All standard medications are prescribed. The patient is followed up by phone in the second, fourth, eighth and tenth weeks and in the sixth week, re-examination, control of drug side effects, filling out the questionnaire, re-administration of the drugs are performed. Finally, in the twelfth week, the final visit will be made and the questionnaires will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with cystic fibrosis with clinical signs of sinusitis over 6 years of age who refer to the pulmonary clinic of Mofid Children's Hospital and if they receive informed consent from the parents of children and children over 6 years old Criteria for not entering: Patients with cystic fibrosis under 6 years of age, lack of clinical signs of sinusitis, patients in need of hospitalization and patients with underlying conditions such as allergic bronchopulmonary aspergillosis (ABPA) and Tuberculosis
Intervention groups
All standard and required drugs are prescribed to the patient and in the experimental group, in addition to the above treatments, combined honey syrup and in the control group, the placebo is also prescribed. Consumption of compound honey syrup and placebo, 5-10 cc (according to the weight of children) in 100 cc of boiled and lukewarm water twice a day 30 minutes after meal.
Main outcome variables
Runny nose ,Nasal obstruction ,Ear fullness ,Dizziness ,Ear pain ,Facial pain/pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201009048976N1
Registration date: 2021-01-23, 1399/11/04
Registration timing: registered_while_recruiting

Last update: 2021-01-23, 1399/11/04
Update count: 0
Registration date
2021-01-23, 1399/11/04
Registrant information
Name
Samira Borhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 5872
Email address
samiraborhani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of compound honey syrup on clinical manifestations of chronic sinusitis in cystic fibrosis (CF) patients
Public title
The effect of compound honey syrup on chronic sinusitis in cystic fibrosis patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cystic fibrosis with clinical signs of sinusitis over 6 years of age who refer to the pulmonary Clinic of Mofid Children's Hospital and enter the study with the informed consent of the parents of children and children over 6 years of age.
Exclusion criteria:
Patients with cystic fibrosis under 6 years of age referred to the pulmonary Clinic of the Mofid Children's Hospital, lack of clinical signs of sinusitis, patients in need of hospitalization and patients with increased cough, sputum and fever, and patients with underlying conditions such as allergic bronchopulmonary aspergillosis(ABPA) and Tuberculosis are not included in the study.
Age
From 6 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is based on a table of random numbers and blocks of 4 and the study is double-blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
The compound honey syrup and placebo have been coded for blinding. The patient and researcher are unaware of the type of drug administered.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman Ave., Sh. Aarabi Ave., Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.441

Health conditions studied

1

Description of health condition studied
cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis

Primary outcomes

1

Description
Runny nose
Timepoint
At the beginning of the study(Before starting the intervention), the end of the Sixth and twelfth week
Method of measurement
SNOT questionnair

2

Description
Nasal obstruction
Timepoint
At the beginning of the study, the end of the Sixth and twelfth week
Method of measurement
SNOT questionnair

3

Description
Ear fullness
Timepoint
At the beginning of the study, the end of the Sixth and twelfth week
Method of measurement
SNOT questionnair

4

Description
Dizziness
Timepoint
At the beginning of the study, the end of the Sixth and twelfth week
Method of measurement
SNOT questionnair

5

Description
Ear pain
Timepoint
At the beginning of the study, the end of the Sixth and twelfth week
Method of measurement
SNOT questionnair

6

Description
Facial pain/pressure
Timepoint
At the beginning of the study, the end of the Sixth and twelfth week
Method of measurement
SNOT questionnair

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to all the standard and required medicines for the patient, in the experimental group, compound honey syrup is also prescribed. Consumption of compound honey syrup, 5-10 cc (according to the weight of children, in the weight of over 30 kg, 10 cc and in the low weight of 30 kg, 5 cc) in 100 cc of boiled and lukewarm twice a day 30 minutes after the meal. The study period is 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: In addition to all the standard and required drugs for the patient, in the control group, placebo approved by the pharmaceutical group (containing sodium saccharin) is also prescribed. Consumption of placebo syrup is 5-10 cc (according to the weight of children, in the weight of over 30 kg, 10 cc and in the low weight of 30 kg, 5 cc) in 100 cc of boiled and lukewarm water twice a day 30 minutes after the meal.The study period is 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid pediatric hospital
Full name of responsible person
samiraborhani
Street address
Mofid pediatric hospital, Shariati Ave, Tehran, Iran
City
tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2222 7021
Email
samiraborhani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sponsor Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
samiraborhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
samiraborhani
Position
MD, PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
Email
samiraborhani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahpar Kaveh Bagh Bahadorani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave.
City
tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6029
Email
samiraborhani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
samiraborhani
Position
MD, PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
samiraborhani@yahoo.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
Publishing results in the form of a Ph.D. thesis and an article indexing in ISI
When the data will become available and for how long
After PhD thesis defence
To whom data/document is available
Public
Under which criteria data/document could be used
For research reasons
From where data/document is obtainable
Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
Approval of the relevant responsible
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