Evaluating the effect of pomegranate extract on the antibody titer of heat-shock protein (HSP) 70 , some serum immunologic factors, oxidative stress status and spirometry test in patients with persistent allergic asthma with mild and moderate severity
In this study, the effect of pomegranate extract on asthma will be examined.
Design
A clinical trial with control group including a sample size of 68 people,with parallel group, double-blind, randomized
Settings and conduct
This study is a randomized, double-blind, placebo-controlled trial, which the researcher and participants will be blinded by encoding pomegranate extract and placebo by the other person.
The subjects are patients with asthma who will be selected from the pulmonary department of Imam Khomeini hospital in Ahvaz, which will have the inclusion criteria to enter the study. The participants will be randomized through the statistical method of permuted block. Blocks will be determined using statistical software.
Participants/Inclusion and exclusion criteria
Ages 18 to 65 years,
Mild to moderate persistent allergic asthma,
Body mass index: 18.5-30
Intervention groups
2 groups: one group will received supplement of pomegranate extract and the other group will be presented placebo(toasted flour).
Main outcome variables
antibody titer of heat-shock protein (HSP) 70
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200205046384N1
Registration date:2020-05-09, 1399/02/20
Registration timing:registered_while_recruiting
Last update:2020-05-09, 1399/02/20
Update count:1
Registration date
2020-05-09, 1399/02/20
Registrant information
Name
Zainab Shateri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8330
Email address
shateri.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of pomegranate extract on the antibody titer of heat-shock protein (HSP) 70 , some serum immunologic factors, oxidative stress status and spirometry test in patients with persistent allergic asthma with mild and moderate severity
Public title
investigating the effect of pomegranate extract in asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 65 years
Patients with mild to moderate persistent allergic asthma, Forced Expiratory Volume in First Second(FEV1) greater than 60%
Body mass index(BMI):18.5-30
Both sexes
Exclusion criteria:
smoking
Diabetes
Pregnancy and lactation
Autoimmune diseases
Malignancies
Digestive, liver or kidney problems
Pneumonia
Other pulmonary diseases
Antioxidant usage
Blood lipids and blood pressure lowering drugs (Statin and ACE Inhibitors)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomized through the statistical method of permuted block. Blocks will be determined using statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and participants are blinded by coding the drug in the form of A and B, so that someone else is asked to encode the pomegranate extracts and placebo to A and B which are similar in appearance. The participants and the researcher will be uninformed of the type of intervention. As a result, the study will be performed in the forms of double blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Ahvaz Jondishapour University of Medical Sciences
Street address
Nutrition dep, faculty of Paramedicine, Ahvaz Jondishapour University of Medical Sciences, Golestan Highway, Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-02-21, 1398/12/02
Ethics committee reference number
IR.AJUMS.REC.1398.905
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.0
ICD-10 code description
آسم
Primary outcomes
1
Description
Anti-heat shock protein(HSP) 70
Timepoint
at the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on blood test using ELISA- ng /ml
2
Description
Forced Vital Capacity(FVC)/Forced Expiratory Volume in First Second(FEV1)، FEV1، FVC
Timepoint
at the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on the result of the spirometer- Variable scale: percent
Secondary outcomes
1
Description
High sensitivity C-reactive protein (hsCRP)
Timepoint
At the beginning of the study and 8 weeks after intervention
Lipid profile(Triglycerides, total cholesterol, high density lipoprotein(HDL), low density lipoprotein(LDL))
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Based on laboratory measurements by enzymatic method-mg/dl
3
Description
blood pressure
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on the results of the Easy Life aneroid Sphygmomanometer-mmHg
4
Description
Clinical variables and general patient status
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on a questionnaire filled by a specialist physician
5
Description
IL-10
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on laboratory measurements-pg/ml
6
Description
IL-35
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on laboratory measurements-pg/ml
7
Description
oxidative status(pro-oxidant-antioxidant balance(PAB)، total antioxidant capacity(TAC)،malondialdehyde(MDA))
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on laboratory measurements-micromole /ml and HK
Intervention groups
1
Description
Intervention group: group receiving pomegranate extract 500 mg / day in capsule form (two 250 mg capsules daily). Drug production center: The institute of medicinal plants research of Jahad Daneshgahi. The duration of drug use is 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo-receiving group: Two capsules daily containing 250 mg toasted flour . Drug Production Center: The institute of medicinal plants research of Jahad Daneshgahi. The duration of drug use is 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini hospital
Full name of responsible person
Maryam Haddadzadeh Shoushtari. Lung specialist
Street address
Imam Khomeini hospital,24 metry AVe, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Phone
+98 61 3336 7543
Fax
+98 61 3336 1544
Email
shateri.z@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Development Unit, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
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
Zainab Shateri
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department,Faculty of Paramedicine, Ahvaz Jondishapour University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098613311
Email
shateri.z@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zainab Shateri
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6137515794
Phone
0098613311
Email
shateri.z@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zainab Shateri
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Paramedicine,Ahvaz Jondishapour University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098613311
Email
shateri.z@ajums.ac.ir
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