The efficacy of Compound Honey Syrup on Fractional Exhalation Nitric Oxide (FeNO) Changes, Pulmonary Symptoms and Body Mass Index (BMI) in Cystic Fibrosis Patients
The efficacy of compound honey syrup on fractional exhaled nitric oxide (FeNO) changes, pulmonary symptoms and body mass index in patients with cystic fibrosis
Design
A clinical trial, without control group and blinding in 40 cystic fibrosis patients over 6 years, and follow up for three months To check the effect of the drug
Settings and conduct
patients 6 years and older with fibrocystic cysts referred to the pulmonary clinic of Mofid Hospital in 2019 and 2020.after obtaining the consent, the demographic characteristics questionnaire and the CFQ-R questionnaire for the patient are completed.FeNO test and recorded BMI measurements Then the necessary standard treatments and in addition compound honey syrup are prescribed.The method of use and possible side effects and how to contact the researcher are fully explained.Then the information is analyzed before and after starting the treatment with syrup.
Participants/Inclusion and exclusion criteria
All patients with cystic fibrosis older than 6 years referred to the Lung Clinic of Mofid Children Hospital who are able to perform FeNO testing are enrolled if informed consent is obtained from parents and children.
Exclusion criteria:
Patients with cystic fibrosis under 6 years of age referring to Pediatric Hospital Lung Clinic, patients in need of hospitalization and patients who have exacerbation , patients with underlying diseases such as allergic bronchopulmonary aspergillosis , Patients with another acute illness during treatment, patients who are sensitive to each component of the compound honey syrup, and patients who wish to withdraw from the study. Patients unable to perform FeNO test.
Intervention groups
Administration of compound honey syrup in cystic fibrosis patients to evaluate its effect on FeNO, pulmonary symptoms and Body Mass Index
The efficacy of Compound Honey Syrup on Fractional Exhalation Nitric Oxide (FeNO) Changes, Pulmonary Symptoms and Body Mass Index (BMI) in Cystic Fibrosis Patients
Public title
The Efficacy of Compound Honey Syrup in Cystic Fibrosis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with cystic fibrosis over 6 years who are able to perform FeNO test.
Exclusion criteria:
Patients with cystic fibrosis under 6 years
Patients in need of hospitalization
Patients who have exacerbation (increased cough, sputum, fever and need to be hospitalized)
Patients with underlying diseases such as allergic bronchopulmonary aspergillosis, heart failure, tuberculosis
Patients with another acute illness during treatment
Patients who are allergic to any component of the compound honey syrup
Patients requesting exclusion
Patients unable to perform FeNO test.
Age
From 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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 ملی اخلاق در پژوهش های زیست پزشکی
Street address
Evin, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.SBMU.MSP.REC.1398.877
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
ICD-10 code description
ICD-10
Primary outcomes
1
Description
FeNO
Timepoint
At the beginning of the study and 12 weeks after the administration of the compound honey syrup
Method of measurement
FeNO Testing Device
2
Description
Body Mass Index
Timepoint
At the beginning of the study and 12 weeks after the administration of the compound honey syrup
Method of measurement
Weight / Squared Height
3
Description
Pulmonary Symptoms
Timepoint
At the beginning of the study and 12 weeks after the administration of the compound honey syrup
Method of measurement
CFQ-R questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes patients with cystic fibrosis over 6 years of age referred to the pulmonary clinic of Mofid Children's Hospital who are able to perform FeNO test.Lung examination for pulmonary symptoms and FeNO test performed by standing pulmonary fellowship, patient's BMI is measured.In the next stage, all standard and required treatments of the patient are prescribed, and in addition to routine treatments, compound honey syrup is also prescribed.Consumption of compound honey syrup is 5-10 cc (depending on the weight of children, 10 cc over 30 kg and 5 cc under 30 kg) in 100 cc of boiled water twice a day 30 minutes after a meal.Compound honey syrup is produced by NIAK Pharmaceutical Company with the permission of the Food and Drug Administration of the Ministry of Health and Medical Education. This syrup contains compounds of honey, cinnamon, ginger, saffron and cardamom .The patient was followed up by the researcher in the second and fourth weeks after the first visit and in the sixth week, the patient referred again to the pulmonary clinic of Mofid Children's Hospital for examination by a pulmonologist and then in the eighth and tenth weeks followed by the researcher by phone, and finally in the twelfth week for the final visit to be examined by a pulmonologist, FeNO test and CFQ-R questionnaire in terms of Pulmonary symptoms are also complemented.
Category
Treatment - Drugs
2
Description
Control group: Includes patients with cystic fibrosis over 6 years of age referred to the Pulmonary Clinic of Mofid Children's Hospital who are able to perform FeNO testing. The patient is examined by the pulmonary fellowship for pulmonary symptoms and BMI, and each patient's information is entered into a CFQ-R questionnaire. In other words, information is collected for each patient before starting treatment with honey syrup.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children hospital
Full name of responsible person
Nafise Fadavi
Street address
Shariati street
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 7021
Fax
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Web page address
http://mch.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
دکتر افشین زرقی
Street address
Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
http://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
Nafise Fadavi
Position
Ped pulmonology fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 5, Yas building, Mobarezan Ave, Bozorgmehr street
City
Ardestan
Province
Isfehan
Postal code
8156676155
Phone
+98 31 3230 2382
Fax
Email
nf.fadavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafise Fadavi
Position
Ped pulmonology fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 5, Yas building, Mobarezan Ave, Bozorgmehr street
City
Ardestan
Province
Isfehan
Postal code
8156676155
Phone
+98 31 3230 2382
Fax
Email
nf.fadavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafise Fadavi
Position
Ped pulmonology fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 5, Yas building, Mobarezan Ave, Bozorgmehr street
City
Ardestan
Province
Isfehan
Postal code
8156676155
Phone
+98 31 3230 2382
Fax
Email
nf.fadavi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available