Evaluation of the effect of compound honey syrup on Fractional exhalation Nitric Oxide (FeNO) changes in Cystic Fibrosis patients
Design
An intervention study of before-after clinical trials and a sample size of 30 people.
Settings and conduct
This project will be done in Mofid Children's Hospital in Tehran and the study will be performed as a before-after Clinical Trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with cystic fibrosis over 6 years of age who are referred to the pulmonary Clinic of Mofid Children's Hospital, who have been diagnosed by a pediatric lung specialist and will enter the study with the informed consent of the parents of children and children over 6 years old.
Exclusion criteria: Patients with cystic fibrosis under 6 years of age referred to the pulmonary clinic of a children's hospital, patients in need of hospitalization, and patients with a disease attack (increased cough, sputum, fever, and need for hospitalization); patients with underlying diseases such as allergic bronchopulmonary aspergillosis, heart failure, and tuberculosis; patients who develop other acute illnesses during treatment, patients who are allergic to any of the components of the compound honey syrup, and patients who have decided to leave the study at their own request. Patients who are unable to cooperate in performing the FeNO test.
Intervention groups
After obtaining informed consent, all standard and required medications are prescribed for the patient also the compound honey syrup is prescribed. Consumption of this syrup is 5-10 cc (depending on the age and weight of children) in 100 CC of boiled and lukewarm water twice a day 30 minutes after a meal for 12 weeks.
Main outcome variables
Fractional exhalation Nitric Oxide, weight, height, body mass index, Staphylococcus aureus and Pseudomonas aeruginosa culture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200428047229N2
Registration date:2020-07-15, 1399/04/25
Registration timing:registered_while_recruiting
Last update:2020-07-15, 1399/04/25
Update count:0
Registration date
2020-07-15, 1399/04/25
Registrant information
Name
Hanieh Tahermohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 4811
Email address
dr.hmohammadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-29, 1399/04/09
Expected recruitment end date
2020-12-29, 1399/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of compound honey syrup on Fractional exhalation Nitric Oxide (FeNO) changes in Cystic Fibrosis patients
Public title
The effect of compound honey syrup on the airways of cystic fibrosis patients Fractional exhalation Nitric Oxide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All cystic fibrosis patients over 6 years of age should be referred to the pulmonary clinic of Mofid Children's Hospital, diagnosed by a pediatric lung specialist.
Conscious consent of parents of children and children over 6 years of age
Exclusion criteria:
Cystic fibrosis patients under 6 years of age referred to the pulmonary clinic of Mofid Children's Hospital
Patients in need of hospitalization
Patients who have attack symptoms of the disease (increased cough, sputum, fever, and need for hospitalization).
Patients with underlying diseases such as allergic bronchopulmonary aspergillosis, heart failure and tuberculosis.
Patients with other acute illnesses during treatment.
Patients who are allergic to any of the components of the compound honey syrup.
Patients who have decided to leave the study at their own request.
Patients who are unable to co-operate with the FeNO test.
Age
From 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی
Street address
خیابان یمن، دانشگاه علوم پزشکی شهیدبهشتی
City
تهران
Province
Tehran
Postal code
1985717443
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.279
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
Fractional exhalation Nitric Oxide
Timepoint
At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup
Method of measurement
FeNO monitor (NObreath®)
Secondary outcomes
1
Description
Weight
Timepoint
At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup
Method of measurement
Scales
2
Description
Height
Timepoint
At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup
Method of measurement
Standing position and by meters
3
Description
Body Mass Index (BMI)
Timepoint
At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup
Method of measurement
Weight/(height)2
4
Description
Staphylococcus aureus bacterial culture
Timepoint
At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup
Method of measurement
Preparation of sputum or throat swab after chest physiotherapy in the absence of sputum
5
Description
Pseudomonas aeruginosa bacterial culture
Timepoint
At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup
Method of measurement
Preparation of sputum or throat swab after chest physiotherapy in the absence of sputum
Intervention groups
1
Description
Intervention group: After receiving informed consent from the parents of patients and children over 6 years of age, all standard and required drugs for cystic fibrosis patients are prescribed and in addition to the above treatments, the compound honey syrup is also prescribed. In the first visit (before starting the syrup) FeNO test, weight and height are taken from the patients and sputum culture is requested. Then compound honey syrup, 5-10 cc (depending on the age and weight of children) in 100 CC of boiled and lukewarm water is administered twice a day for 30 minutes after a meal for 6 weeks, and in weeks 2 and 4, the patient is followed up for the correct use of the drug. At 6 weeks, the patient is visited again, and the drugs and syrup are prescribed again for 6 weeks, and after that, the patient is followed up in the 8th and 10th weeks in terms of proper drug use. Finally, The patient is visited again in the 12th week, and FeNO test, weight and height are taken from the patients and also sputum culture is requested.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's hospital
Full name of responsible person
Hanieh Tahermohammadi
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.hmohammadi@sbmu.ac.ir
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
Tehran - Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yemen St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
dr.hmohammadi@sbmu.ac.ir
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
Hanieh Tahermohammadi
Position
Assistant of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.hmohammadi@sbmu.ac.ir
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
Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
skaveh83@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
hanieh Tahermohammadi
Position
Assistant of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.hmohammadi@sbmu.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
Publishing results in the form of a Ph.D. thesis, an article indexing in ISI, and an article indexing in Pub Med
When the data will become available and for how long
After Ph.D. thesis defense
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