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The preventive effect of aqueous – alcoholic extract of Zataria multiflora and carvacrol on asthma disease

Protocol summary

Summary
Objectives: determine the effect of hydro-alcoholic extract of Zataria multiflora Boiss and carvacrol on treatment (prevention) of asthma. Design: Randomized, double-blind, controlled with placebo, phase II trial Setting and conduct: In this study, sixty patients with moderate to severe asthma were selected and treated for two months in four groups including: treated patients with hydro-alcoholic extract (in two doses five and ten milligrams per kilogram per day), patients receiving carvacrol (one mg per kg per day) and patients receiving placebo. Major Inclusion and Exclusion criteria: Inclusion criteria including; the diagnosis of asthma according to the World Health Organization criteria for the diagnosis and management of asthma (GINA), the willingness of patients to participate in the project. Exclusion criteria; intolerance of Zataria multiflora Boiss side effects (nausea, vomiting, diarrhea). Intervention: Prescription of Zataria multiflora Boiss syrup and carvacrol for two months to asthma patients. main outcome measures (variables): Measurement of pulmonary function tests, blood cells, inflammatory mediators in serum such as hsCRP, IL-10, IL-4, IFN-ᵞ and gene expression of IL-10, IL-4, IFN-ᵞ in peripheral blood lymphocytes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014101519546N1
Registration date: 2016-11-26, 1395/09/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Azam Alavinezhad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2217
Email address
alavina901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The preventive effect of aqueous – alcoholic extract of Zataria multiflora and carvacrol on asthma disease
Public title
The effect of zataria multiflora boiss on symptoms of asthmatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of asthma, according to World Health Organization criteria, guidelines on diagnosis and management of asthma (GINA), patient willingness to participate in the project. exclusion criteria: the existence of systemic diseases, Taking other medicines with antioxidant properties, taking any herbal thyme intolerance side effects (nausea, vomiting, diarrhea, etc.), inflammatory disease, gestational, age below 12 years
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

2

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ghorshi beelding, Daneshgah street
City
Mashhad
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
IR.MUMS.REC.1392.91

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45.8
ICD-10 code description
Mixed asthma

Primary outcomes

1

Description
Volume and lung capacity
Timepoint
Baseline, the end of First and second month
Method of measurement
Spirometry

2

Description
Serum cytokines
Timepoint
zero and sixty days
Method of measurement
ELAISA

3

Description
Cells blood
Timepoint
zero, thirty and sixty days
Method of measurement
Auto analyzer

4

Description
Gen expression
Timepoint
zero and sixty days
Method of measurement
Real time PCR

Secondary outcomes

empty

Intervention groups

1

Description
Control group: placebo (5 ml syrup orally three times daily)
Category
Treatment - Drugs

2

Description
Intervention group 1: Zataria multiflora Boiss syrup (5 mg milligrams per kilogram daily)
Category
Treatment - Drugs

3

Description
Intervention group 2: Zataria multiflora Boiss syrup (10 milligrams per kilogram daily)
Category
Treatment - Drugs

4

Description
Intervention group 3: Capsule of active ingredient (carvacrol 1.2 milligrams per kilogram daily)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Fariba Rezaei talab
Street address
Imam Reza Hospital, Special clinic
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Avenue, Building Qureshi
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad hossein Boskabady
Position
Respiratory Physiology PhD
Other areas of specialty/work
Street address
Department of Physiology, Faculty of Medicine, Ferdowsi University campus,Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3800 2228
Fax
Email
boskabadymh@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neurogenic Inflammation Research Centre and Dept. of Physiology, School of Medicine, Mashhad Univers
Full name of responsible person
Mohammad hossein Boskabady
Position
Respiratory Physiology PhD
Other areas of specialty/work
Street address
Department of Physiology, Faculty of Medicine, Ferdowsi University campus,Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3800 2228
Fax
Email
boskabadymh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam Alavinezhad
Position
Physiology PhD candidate
Other areas of specialty/work
Street address
Department of Physiology, Faculty of Medicine, Ferdowsi University campus,Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3800 2228
Fax
Email
alavina901@mums.ac.ir
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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