Introduction: Propolis has a long history of medicinal use, dating back to 250 B.C. This substance derived from honey and it is harmless. According to its inhibitory effect on IL2, IL6, IL1b, INFy and INF10 it potentially is able to improve asthma. It has also showed great anti_inflammatory effect because of its rich CAFÉ (caffeic acid phenethyl ester) content.
Objectives: The propose of this study is to assess the effect of propolis on clinical findings and physiological parameters of asthma.
Materials and methods: Inclusion criteria: Fifty subjects suffering from moderate asthma who have not received drugs for treatment of asthma will be enrolled in this double blind randomized placebo-controlled clinical trial. Subjects suffering from active infection, cigarette smoking and other respiratory diseases will be excluded from study. Primary outcome includes cough, score of ACT questionnaire, and FENO (Expiratory fraction of Nitric Oxide). Time point of outcome measurement is at the beginning of the study and at the end trial (3 weeks). The patients will be divided randomly into 2 groups whom one group will receive Propolis tablet and the other group will receive placebo for 3 weeks. A company will produce the Propolis and placebo in a similar shape. The physician and pharmacist will be blinded to the type of drug or placebo. Telephone call will use for home follow up. The study was approved by our local ethical committee and written inform consent will be given.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209302695N4
Registration date:2015-04-29, 1394/02/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-29, 1394/02/09
Registrant information
Name
Majid Mirsadraee
Name of organization / entity
Islamic Azad University- Mashhad branch
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 6694
Email address
majidmirsadraee@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad Branch, Islamic Azad University
Expected recruitment start date
2014-12-28, 1393/10/07
Expected recruitment end date
2015-12-19, 1394/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Propolis on clinical and physiological parameters of moderate Asthma. A double blind randomized placebo- controlled clinical trial.
Public title
Effect of Propolis on moderate asthma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: New subjects suffering from cough or dyspnea with an intermittent course and history of airway hyper responsiveness; controller drugs was not started; spirometry of the patients showing moderate asthma (forced expiratory volume in the first second between 60 to 80%).
Exclusion criteria: mild (FEV1 mare than 80%); severe asthma (FEV1<60%); respiratory infection; treatment with systemic corticosteroid; rhinosinusitis; gastroesophageal reflux disease; other obstructive lung disease; Churg–Strauss syndrome; smokers; vocal cord dysfunction; reactive airway dysfunction syndrome.
Age
From 7 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
All recruited asthmatic subjects will randomly divided into two groups (Propolis and placebo) by computer generated randomization list. The physician and pharmacist are blind to the exact drug. Propolis and placebo will be packed in bottle with similar appearance and they will get code according to the randomization schedule.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Medical school Islamic Azad University- Mashhad branch
Street address
Shahin Far Building , Azadi street , sarab alley
City
mashhad
Postal code
۹۱۷۸۶۷۳۷۹۹
Approval date
2012-04-26, 1391/02/07
Ethics committee reference number
A34-18
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
j459
ICD-10 code description
asthma , unspecified
Primary outcomes
1
Description
Fractional exhaled Nitric Oxide (FENO)
Timepoint
at the beginning of the study and at the end of the three weeks treatment
Method of measurement
expiratory nitric oxide test with NObreath equipment
2
Description
ACT score test
Timepoint
At the beginning of the study and at the end of the three weeks treatment
Method of measurement
ACT questionnaire
Secondary outcomes
1
Description
Interleukin -4 (IL-4)
Timepoint
At the begining and at the end of the three weeks of therapy
Method of measurement
ELIZA
2
Description
Interleukin-17 (IL-17)
Timepoint
At the begining and at the end of the three weeks of therapy
Method of measurement
ELIZA
3
Description
Interferon-Y (INF-Y)
Timepoint
At the begining and at the end of the three weeks of therapy
Method of measurement
ELIZA
4
Description
Toll Like Receptor-2 (TLR-2)
Timepoint
At the begining and at the end of the three weeks of therapy
Method of measurement
ELIZA
5
Description
Dyspnea
Timepoint
At the beginning of the study and at the end of the three weeks treatment
Method of measurement
MMRC questionnaire
6
Description
Forced expiratory volume in one second
Timepoint
at the beginning of the study and at the end of the three weeks treatment
Method of measurement
spirometry
7
Description
inflammatory cells of sputum
Timepoint
At the beginning of the study and at the end of the three weeks treatment
Method of measurement
sputum cytology
8
Description
Cough
Timepoint
Before and after three weeks of trial time point
Method of measurement
Clinical assessment
Intervention groups
1
Description
Moderate stage asthmatic subjects whom were not previously treated will be evaluated for clinical findings, spirometry, asthma control test, FENO, sputum cytology, IL-4 ، IFN-γ ، IL-17 and TLR-2 at the onset of the study. The subjects will be randomly divided in to two groups. Package of propolis and placebo will be produced in similar appearance and case group will recieve a pack ot Propolis which each pack contains 21 pills and each pill contains 125 mg. The package will get coded base on the random number table by a third person whom will be blind to groups. The code will be saved when the drug gives to the patient. The physician and pharmacist will blind to the codes. The subjects will follow during three weeks period of treatment by telephone call for assessing the side effects and exacerbation of symptoms. Emergency usage of Salbutamol inhaler will be permitted as needed. After 3 weeks the mentioned assessment will be repeated.
Category
Treatment - Drugs
2
Description
Control group: Moderate stage asthmatic subjects who randomly allocated in control group will be evaluated for clinical findings, spirometry, asthma control test, FENO, sputum cytology, IL-4 ، IFN-γ ، IL-17 and TLR-2 as the same as trial group. Package of propolis and placebo will produce in similar appearance and in this group the pack contains 21 placebo pills. The package will get coded base on the random number table by a third person who will be blind to groups. The physician and pharmacist will keep blind to the codes. The subjects will follow during three weeks period of treatment by telephone call for assessing the side effects and exacerbation of symptoms. Emergency usage of Salbutamol inhaler will be permitted as needed. After 3 weeks the mentioned assessment will be repeated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Mashhad Branch
Full name of responsible person
Mojtaba Mashkat
Street address
Shahin-far building, Azadi street, Sarab alley
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Mashhad
Full name of responsible person
Mojtaba Meshkat
Street address
Shahin-far building, Azadi street, Sarab alley
City
MAshhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Mashhad
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University- Mashhad Branch
Full name of responsible person
Majid Mirsadraee
Position
Associate professor
Other areas of specialty/work
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Postal code
91786
Phone
+98 51 1882 5505
Fax
+98 51 1881 6965
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
www.mshdiau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University- Mashhad Branch
Full name of responsible person
Majid Mirsadraee MD
Position
Associate professor,
Other areas of specialty/work
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Postal code
91786
Phone
+98 51 1882 5505
Fax
+98 51 1881 6965
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
www.mshdiau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University- Mashhad Branch
Full name of responsible person
Majid Mirsadraee MD
Position
Associate professor,
Other areas of specialty/work
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Postal code
91786
Phone
+98 51 1882 5505
Fax
+98 51 1881 6965
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
www.mshdiau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)