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Survey the effect of saffron supplementation on the antibody titer to heat-shock protein (HSP) 70, hsCRP and spirometry test in patients with moderate persistent allergic asthma

Protocol summary

Summary
Objectives: determination the effect of saffron supplementation on the antibody titer to heat-shock protein (HSP) 70, hsCRP and spirometry test in patients with moderate persistent allergic asthma Design: the study population includes patients referred to the Red Crescent special clinic with diagnosed moderate persistent allergic asthma by doctors. Study groups include saffron and placebo consumer groups. Sample size includes 86 subjects. Study will be done in triple-blind, block randomized and single-center manner and phase 1 clinical trial. Setting and conduct: In this study patients with moderate persistent allergic asthma will randomly divided into saffron and placebo consumer groups and supplementation will be done for 8 weeks. Participants: Inclusion criteria include age between 18 to 65 years old, moderate persistent allergic asthma and normal BMI and exclusion criteria include smoking, diabetes, autoimmune disease, malignancies, gastrointestinal, liver and kidney disease, pneumonia, pregnancy and lactation and not wanting to continue cooperation. Intervention: include saffron capsule consumer and capsule consumer groups. Main outcome variables: Antibody titers to heat shock protein 70, FEV1، FVC، FEV1/FVC, hsCRP, blood pressure, lipid profile, clinical variables and the patient's general status.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012132081N2
Registration date: 2017-04-03, 1396/01/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-03, 1396/01/14
Registrant information
Name
Marzie Zilaee
Name of organization / entity
Department of Nutrition-paramedicine school
Country
Iran (Islamic Republic of)
Phone
+98 910 646 0894
Email address
zilaee.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz jundishapur university of medical sciences
Expected recruitment start date
2017-04-20, 1396/01/31
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of saffron supplementation on the antibody titer to heat-shock protein (HSP) 70, hsCRP and spirometry test in patients with moderate persistent allergic asthma
Public title
Survey the effect of saffron on asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 65 years old, moderate persistent allergic asthma (FEV1 between 40 to 60 percent) according to the physician and normal BMI (up to 27). Inclusion criteria dos not belong to the particular gender and include male and females. Exclusion criteria include smoking, diabetes, pregnancy and lactation, autoimmune disease, malignancies, gastrointestinal, liver and kidney disease, pneumonia and other pulmonary disease and Not wanting to continue cooperation
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
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. Golestan Bolvar. Jundishapur University of Medical Sciences. Research Assistance
City
Ahvaz
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.AJUMS.REC.1395.810

Health conditions studied

1

Description of health condition studied
moderate persistent allergic asthma
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Antibody titers to heat shock protein 70
Timepoint
Before and two months after intervention
Method of measurement
according to the Laboratory Measurement-ng/ml

2

Description
FEV1, FVC, FEV1/FVC
Timepoint
Before and two months after intervention
Method of measurement
According to the results of the spirometer-scale:percent

Secondary outcomes

1

Description
hsCRP
Timepoint
Before and two months after intervention
Method of measurement
according to the laboratory measurement-mg/dl

2

Description
lipid profile
Timepoint
Before and two months after intervention
Method of measurement
according to the laboratory measurement-mg/dl

3

Description
blood presure
Timepoint
Before and two months after intervention
Method of measurement
according to the results of Sphygmomanometer-mmhg

4

Description
clinical variables and the patient's general status
Timepoint
Before and two months after intervention
Method of measurement
according to the Questionnaires completed by physician superspecialty

Intervention groups

1

Description
Saffron consumer group which receiving 100 mg of saffron per day in capsule form (two 50 mg capsule per day). Drug producing center: growth center of Ahvaz Jundishapur University of medical sciences. Duration of drug consumption is 8 weeks.
Category
Treatment - Drugs

2

Description
Placebo consumer group: consumption two capsules per day which containing starch. Drug producing center: growth center of Ahvaz Jundishapur University of medical sciences. Duration of drug consumption is 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ajvaz Imam Khomeini hospital
Full name of responsible person
Maryam Haddadzadeh shushtari. Lung superspecialist
Street address
Ahvaz. 24 m street. Imam Khomeini hospital. Special clinic
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Behzad Sharif Makhmalzadeh
Street address
Ahvaz-Golestan bolvar-Ahvaz jundishapur univesity of medical sciences-development unit
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of nutrition, paramedicine school
Full name of responsible person
Marzie Zilaee
Position
MSc.Ph.D student
Other areas of specialty/work
Street address
Ahvaz-Jundishapur university of medical sciences
City
Ahvaz
Postal code
00986135715794
Phone
+98 61 3336 7543
Fax
+98 61 3336 1544
Email
zilaee.m@ajums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nutrition-paramedicine school- ahvaz jundishapur university of medical sciences
Full name of responsible person
Marzie Zilaee
Position
Msc. Ph.D student
Other areas of specialty/work
Street address
paramedicine school- ahvaz jundishapur university of medical sciences
City
Ahvaz
Postal code
00986135715794
Phone
+98 61 3336 7543
Fax
+98 61 3336 1544
Email
Zilaee.m@ajums.ac.irmarziezilae@gmail.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Department of nutrition of paramedicine school
Full name of responsible person
Marzie Zilaee
Position
MSc.Ph.D student
Other areas of specialty/work
Street address
Ahvaz-Golestan bolvar-Ahvaz Jundishapur University of medical sciences-paramedicine school-department of nutrition
City
Ahvaz
Postal code
00986135715794
Phone
+98 61 3336 7543
Fax
+98 61 3336 1544
Email
Zilaee.m@ajums.ac.irmarziezilae@gmail.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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