Protocol summary
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Study aim
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In this study, the effect of pomegranate extract on asthma will be examined.
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Design
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A clinical trial with control group including a sample size of 64 people,with parallel group, double-blind, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Ages 18 to 65 years,
Mild to moderate persistent allergic asthma,
Body mass index: 18.5-30
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Intervention groups
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2 groups: one group will received supplement of pomegranate extract and the other group will be presented placebo(toasted flour).
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Main outcome variables
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prooxidant-antioxidant balance
General information
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Reason for update
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Due to the rising dollar and increasing prices of kits, we had to remove a series of parameters in the study, which in turn will change the title and a series of goals in the research design.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200205046384N1
Registration date:
2020-05-09, 1399/02/20
Registration timing:
registered_while_recruiting
Last update:
2021-03-01, 1399/12/11
Update count:
1
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Registration date
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2020-05-09, 1399/02/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-20, 1399/02/01
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Expected recruitment end date
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2020-11-20, 1399/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of pomegranate extract on some serum immunologic factors(IL-35، hs-CRP), oxidative stress status (PAB) and spirometry test in patients with persistent allergic asthma with mild and moderate severity
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Public title
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investigating the effect of pomegranate extract in asthma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 pressure-lowering drugs (Statin and ACE Inhibitors)
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The participants will be randomized through the statistical method of permuted block. Blocks will be determined using statistical software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-21, 1398/12/02
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Ethics committee reference number
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IR.AJUMS.REC.1398.905
Health conditions studied
1
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Description of health condition studied
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Asthma
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ICD-10 code
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J45.0
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ICD-10 code description
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آسم
Primary outcomes
1
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Description
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prooxidant-antioxidant balance
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Timepoint
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at the beginning of the study and 8 weeks after the intervention
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Method of measurement
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Based on blood test using calorimetry
2
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Description
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Forced Vital Capacity(FVC)/Forced Expiratory Volume in First Second(FEV1)، FEV1، FVC
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Timepoint
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at the beginning of the study and 8 weeks after the intervention
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Method of measurement
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Based on the result of the spirometer- Variable scale: percent
Secondary outcomes
1
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Description
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High sensitivity C-reactive protein (hsCRP)
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Timepoint
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At the beginning of the study and 8 weeks after intervention
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Method of measurement
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Laboratory measurement (quantitative luminescence) - mg / dl
2
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Description
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blood pressure
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Timepoint
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At the beginning of the study and 8 weeks after the intervention
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Method of measurement
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Based on the results of the Easy Life aneroid Sphygmomanometer-mmHg
3
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Description
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Clinical variables and general patient status
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Timepoint
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At the beginning of the study and 8 weeks after the intervention
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Method of measurement
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Based on a questionnaire filled by a specialist physician
4
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Description
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IL-35
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Timepoint
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At the beginning of the study and 8 weeks after the intervention
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Method of measurement
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Based on laboratory measurements-pg/ml
5
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Description
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complete blood cell count and differential count
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Timepoint
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At the beginning of the study and 8 weeks after the intervention
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Method of measurement
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Based on laboratory measurement
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available