Comparison the effect of Persian medicine products (containing honey and flax seed) and placebo on Forced Expiratory Volume in First Second and wheezing intensity among patients with severe persistent asthma, A triple-blind randomized placebo-controlled trial
This study aimed to assess the effect of Persian medicine products containing honey and flax seed in patients with severe persistent asthma
Design
A randomized controlled clinical trial and triple blind, parallel study
Settings and conduct
This study is conducted at Shahid Beheshti Hospital in Qom and the blinding will be done using placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with severe persistent asthma over a year; age group of 12-80. Exclusion criteria: Kidney,liver,and heart failure based on the tests, history and physical exam; High blood pressure more than 180 mm Hg; fever; pergnancy and lactation.
Intervention groups
Intervention group: The group will use Persian medicine product (containing honey and flax seed), 40 gram for 3 months, every day. Control group: The group will use placebo, 40 gram every day for 3 months.
Main outcome variables
Forced Expiratory Volume in First Second; Wheezing intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170112031893N5
Registration date:2019-03-16, 1397/12/25
Registration timing:prospective
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Hossein Yusefi
Name of organization / entity
Qom University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0146
Email address
driran1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Persian medicine products (containing honey and flax seed) and placebo on Forced Expiratory Volume in First Second and wheezing intensity among patients with severe persistent asthma, A triple-blind randomized placebo-controlled trial
Public title
The effect of a Persian medicine product on patients with severe persistent asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe persistent asthma over a year
Age group 12-80
Exclusion criteria:
Kidney,liver,and heart failure based on the tests, history and physical exam
High blood pressure more than 180 mm Hg
Fever
Pergnancy and lactation;
Age
From 12 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups using random numbers table developed by Random Allocation Software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, placebo will be used for blinding in which placebo is very similar to the main drug in terms of color and taste. Therefore, patients, statistical analyst and physicians won't bet aware of the allocation of patients to either drug or placebo group and someone outside the group is aware of the allocation of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
Qom
Province
Ghoum
Postal code
87366-37169
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.MUQ.REC.1397.177
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.5
ICD-10 code description
Severe persistent asthma
Primary outcomes
1
Description
Forced Expiratory Volume in First Second
Timepoint
Before and after the intervention (end of month 3)
Method of measurement
Spirometry testing
Secondary outcomes
1
Description
Wheezing intensity determination
Timepoint
At the first of the study(before intervention) and 3 months after intervention
Method of measurement
History and physical exam with stethoscope
Intervention groups
1
Description
Intervention group: The group will use Persian medicine product (containing honey and flax seed), 40 gram for 3 months, every day.
Category
Treatment - Drugs
2
Description
Control group: The group will use placebo, 40 gram every day for 3 months.The placebo contains edible color, aspartame and corn flour, and is made by Tehran University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Hasan Adeli Nia
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
huqom1394@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein saghafi
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3886 0146
Email
driran1399@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Hasan Adeli Nia
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonary Medicine
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
huqom1394@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Muhammad Hossein Yusefi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Internal medicine
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Muhammad Hossein Yusefi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Internal medicine
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
With attention to the type of study and publication of the article, there is no need to do this