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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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History
# Registration date Revision Id
2 2021-02-22, 1399/12/04 173263
1 2020-05-09, 1399/02/20 133494
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  • Protocol summary

    A clinical trial with control group including a sample size of 68 people,with parallel group, double-blind, randomized
    A clinical trial with control group including a sample size of 64 people,with parallel group, double-blind, randomized
    کارآزمایی بالینی دارای گروه کنترل شامل حجم نمونه 68 نفر، با گروه های موازی ، دو سویه کور ، تصادفی شده
    کارآزمایی بالینی دارای گروه کنترل شامل حجم نمونه 64 نفر، با گروه های موازی ، دو سویه کور ، تصادفی شده
    antibody titer of heat-shock protein (HSP) 70
    prooxidant-antioxidant balance
    تیتر آنتی بادی پروتئین شوک حرارتی 70
    تعادل پیش اکسیدانی-آنتی اکسیدانی

  • General information

    68
    64
    empty
    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.
    empty
    به علت بالا رفتن دلار و افزایش قیمت کیت ها ناچار به حذف یک سری از پارامترها در مطالعه شدیم که به تبع آن عنوان و یک سری از اهداف در طرح تحقیقاتی تغییر خواهد کرد.
    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
    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
    بررسی تاثیر عصاره انار بر تیتر آنتی بادی پروتئین شوک حرارتی 70 ، برخی از فاکتورهای ایمونولوژیک سرمی،وضعیت اکسیداتیو و تست اسپیرومتری در افراد مبتلا به آسم آلرژیک پایدار با شدت خفیف و متوسط
    بررسی تاثیر عصاره انار بر برخی از فاکتورهای ایمونولوژیک سرمی (IL-35، hs-CRP)،وضعیت اکسیداتیو (PAB) و تست اسپیرومتری در افراد مبتلا به آسم آلرژیک پایدار با شدت خفیف و متوسط
    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)
    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)
    سیگار کشیدن
    ابتلا به دیابت
    بارداری و شیردهی
    ابتلا به بیماری های اتوایمیون
    بدخیمی ها
    مشکلات گوارشی، کبدی و یا کلیوی
    پنومونی
    سایر بیماری های ریوی
    مصرف آنتی اکسیدان ها
    داروهای کاهنده چربی خون و فشارخون (استاتین و مهارکننده های ACE )
    سیگار کشیدن
    ابتلا به دیابت
    بارداری و شیردهی
    ابتلا به بیماری های اتوایمیون
    بدخیمی ها
    مشکلات گوارشی، کبدی و یا کلیوی
    پنومونی
    سایر بیماری های ریوی
    مصرف آنتی اکسیدان ها
    داروهای کاهنده فشار خون (استاتین و مهارکننده های ACE )

  • Primary outcomes

    #1
    Anti-heat shock protein(HSP) 70
    prooxidant-antioxidant balance
    آنتی بادی پروتئین شوک حرارتی 70
    تعادل پیش اکسیدانی-آنتی اکسیدانی
    Based on blood test using ELISA- ng /ml
    Based on blood test using calorimetry
    بر اساس آزمایش خون با استفاده از روش الایزا- نانوگرم بر میلی لیتر
    بر اساس آزمایش خون با استفاده از کالری متری

  • Secondary outcomes

    #1
    Lipid profile(Triglycerides, total cholesterol, high density lipoprotein(HDL), low density lipoprotein(LDL))
    blood pressure
    پروفایل لیپیدی(تری گلیسیرید، کلسترول توتال،لیپوپروتئین با چگالی بالا، لیپوپروتئین با چگالی پایین )
    فشار خون
    At the beginning of the study and 8 weeks after intervention
    At the beginning of the study and 8 weeks after the intervention
    Based on laboratory measurements by enzymatic method-mg/dl
    Based on the results of the Easy Life aneroid Sphygmomanometer-mmHg
    بر اساس اندازه گیری آزمایشگاهی به روش آنزیمی-میلی گرم بر دسی لیتر
    بر اساس نتایج دستگاه فشار سنج عقربه ای ایزی لایف-میلی متر جیوه
    #2
    blood pressure
    Clinical variables and general patient status
    فشار خون
    متغیرهای بالینی و وضعیت عمومی بیمار
    Based on the results of the Easy Life aneroid Sphygmomanometer-mmHg
    Based on a questionnaire filled by a specialist physician
    بر اساس نتایج دستگاه فشار سنج عقربه ای ایزی لایف-میلی متر جیوه
    بر اساس پرسشنامه پر شده توسط پزشک متخصص
    #3
    Clinical variables and general patient status
    IL-35
    متغیرهای بالینی و وضعیت عمومی بیمار
    اینترلوکین-35
    Based on a questionnaire filled by a specialist physician
    Based on laboratory measurements-pg/ml
    بر اساس پرسشنامه پر شده توسط پزشک متخصص
    بر اساس اندازه گیری آزمایشگاهی-پیکوگرم در میلی لیتر
    #4
    IL-10
    complete blood cell count and differential count
    اینترلوکین-10
    شمارش کامل سلول های خون و شمارش افتراقی
    Based on laboratory measurements-pg/ml
    Based on laboratory measurement
    بر اساس اندازه گیری آزمایشگاهی-پیکوگرم در میلی لیتر
    بر اساس اندازه گیری آزمایشگاهی
    #5
    IL-35
    empty
    اینترلوکین-35
    empty
    At the beginning of the study and 8 weeks after the intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Based on laboratory measurements-pg/ml
    empty
    بر اساس اندازه گیری آزمایشگاهی-پیکوگرم در میلی لیتر
    empty
    #6
    oxidative status(pro-oxidant-antioxidant balance(PAB)، total antioxidant capacity(TAC)،malondialdehyde(MDA))
    empty
    وضعیت اکسیداتیو(تعادل پیش اکسیدانی-آنتی اکسیدانی،ظرفیت آنتی اکسیدانی تام،مالون دی آلدهید)
    empty
    At the beginning of the study and 8 weeks after the intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Based on laboratory measurements-micromole /ml and HK
    empty
    بر اساس اندازه گیری آزمایشگاهی-میکرومول/میلی لیتر و HK
    empty

Protocol summary

Study aim
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 64 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
prooxidant-antioxidant balance

General information

Reason for update
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.
Acronym
IRCT registration information
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
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 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
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 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: 64
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
prooxidant-antioxidant balance
Timepoint
at the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on blood test using calorimetry

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
Method of measurement
Laboratory measurement (quantitative luminescence) - mg / dl

2

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

3

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

4

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

5

Description
complete blood cell count and differential count
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Based on laboratory measurement

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
No more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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