Investigation of the effect of saffron supplementation on the some immunologic factors and oxidative Stress in patients with moderate persistent allergic asthma
Determination of the effect of saffron supplementation on some immunologic factors and oxidative stress in patients with moderate persistent allergic asthma.
Design
An 8 weeks’ double blind randomized placebo-controlled clinical trial with parallel groups.
Settings and conduct
Persons referring to the Imam Khomeini Hospital in Ahvaz who are diagnosed as having a moderate severity of allergic asthma that diagnosed by a physician and have inclusion criteria will be randomly divided into saffron and the placebo group. Blood samples will be collected for the evaluation of Interleukin 10 (IL-10), Transforming growth factor β (TGF-β), Interleukin 35 (IL-35), Prooxidant-antioxidant Balance (PAB) and Complete Blood Count-differential (CBC-diff) at the beginning and after 8 weeks of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 to 65 years old; moderate persistent allergic asthma according to the physician diagnosis and normal body mass index (up to 27). Inclusion criteria dos not belong to the particular gender and includes both of male and female. Non-entry criteria: smoking; diabetes; pregnancy and lactation; autoimmune disease; malignancies; gastrointestinal, liver and kidney disease; pneumonia and other pulmonary disease; taking antioxidant supplements and unwilling to continue the study.
Intervention groups
Individuals will be randomly divided into two groups of 38 patients receiving 100 mg of saffron per day and 38 patients receiving 100 mg of starch (placebo) per day for 8 weeks.
Investigation of the effect of saffron supplementation on the some immunologic factors and oxidative Stress in patients with moderate persistent allergic asthma
Public title
Investigation of the effect of saffron on asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years old
Moderate persistent allergic asthma according to the physician
Normal body mass index (up to 27)
Exclusion criteria:
Smoking
Diabetes
Pregnancy and lactation
Autoimmune disease, malignancies, gastrointestinal, liver and kidney disease, pneumonia and other pulmonary disease
Taking antioxidant supplements
Unwilling to continue the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization will be used to divide the patients into the intervention or placebo groups. According to the sample size and having intervention and control groups, 6 blocks will be used to divide the patients into 2 groups. Possible forms for classifying into the A or B will be written in 6 blocks. The entry of individuals into each of the A or B groups will be done by using the obtained number of blocks from the random table and the layout in the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will receive the 2 capsule that completely identical in shape, size and color. These capsules are prepared by a person who does not involve in the protocol of this study. None of the people involved in the study and the participants not will be aware of the A or B capsules content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Approval date
2018-03-09, 1396/12/18
Ethics committee reference number
IR.AJUMS.REC.1396.1095
Health conditions studied
1
Description of health condition studied
Moderate persistent allergic asthma
ICD-10 code
J45.4
ICD-10 code description
Moderate persistent allergic asthma
Primary outcomes
1
Description
Interleukin 10 (IL-10)
Timepoint
The beginning and end of supplementation
Method of measurement
ELISA method
2
Description
Transforming growth factor β (TGF-β)
Timepoint
The beginning and end of supplementation
Method of measurement
ELISA method
3
Description
Interleukin 35 (IL-35)
Timepoint
The beginning and end of supplementation
Method of measurement
ELISA method
4
Description
Prooxidant-antioxidant Balance (PAB)
Timepoint
The beginning and end of supplementation
Method of measurement
ELISA method
Secondary outcomes
1
Description
Complete Blood Count-differential (CBC-diff)
Timepoint
The beginning and end of the supplementation
Method of measurement
Will be assessed by Sysmex device
2
Description
A frequency of shortness of breath in the day or night
Timepoint
The beginning and end of the supplementation
Method of measurement
Based on the patient's response (number per week)
3
Description
How often do you wake up because of asthma symptoms
Timepoint
The beginning and end of the supplementation
Method of measurement
Based on the patient's response (number per week)
4
Description
Frequency of activity limitation due to asthma and shortness of breath
Timepoint
The beginning and end of the supplementation
Method of measurement
Based on the patient's response (number per week)
5
Description
The frequency of use of salbutamol spray
Timepoint
The beginning and end of the supplementation
Method of measurement
Based on the patient's response (number per week)
Intervention groups
1
Description
Intervention group: consumption 100 mg of saffron (capsule) per day (two 50 mg capsule per day)
Category
Treatment - Drugs
2
Description
Control group: consumption two capsules containing starch per day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Maryam Haddadzadeh
Street address
Imam Khomeini Hospital, 24 meters St, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
00986135715784
Phone
+98 61 3373 8499
Email
Bahreini.m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Highway, Ahvaz, Iran
City
Avaz
Province
Khouzestan
Postal code
00986135715794
Phone
+98 61 3336 7543
Email
Bahreini.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Bahreini
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Phone
+98 61 3373 8499
Email
Bahreini.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Bahreini
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Phone
+98 61 3373 8499
Email
Bahreini.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Bahreini
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Phone
+98 61 3373 8499
Email
Bahreini.m@ajums.ac.ir
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