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The frst phase of clinical trial of of carvacrol to evaluate the safety and tolerability of the substance in humans

Protocol summary

Summary
Objective: Investigation of side effects of carvacrol and its safety and tolerance in humans as named first phase of clinical trial Study design: Non randomize, not blind, without control and placebo, first phase of clinical trial Method: In this study, forty healthy volunteers divided into two groups and each group of twenty people. In the first group one mg/kg of carvacrol and the second group two mg/kg of carvacrol daily as capsules in three servings for one month will be prescribed. The blood and urine samples were taken before and after eating capsules. Main conditions of entry and departure of participants: Inclusion criteria: Physical and mental health and no history of serious illness, the age limit from 20 to 60 years. Exclusion criteria: cardiovascular diseases, brain and vascular disease, malignancy, chronic inflammatory diseases, autoimmune disorders, psychiatric disorders, metabolic diseases, endocrine disorders, other underlying diseases other than those mentioned. Interventions: one and two mg/kg of carvacrol daily as capsules in three servings for one month Main outcome variables: the measurement of biochemical, hormonal and blood factors

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080429191N1
Registration date: 2016-11-19, 1395/08/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-19, 1395/08/29
Registrant information
Name
Vahideh Ghorani Sirjani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8565
Email address
ghoranisv921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The frst phase of clinical trial of of carvacrol to evaluate the safety and tolerability of the substance in humans
Public title
Investigation of side effects of carvacrol in humans
Purpose
Other
Inclusion/Exclusion criteria
Main conditions of entry to study: Physical and mental health; no history of serious illness; the age limit from 20 to 60 years; write informed consent Main condition of exclusion from study: cardiovascular diseases; brain and vascular disease; malignancy; chronic inflammatory diseases; autoimmune disorders; psychiatric disorders; metabolic diseases; endocrine disorders; other underlying diseases other than those mentioned; one tends to withdraw from the study; drug intolerance; drug use by participants during the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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,Ghoreshi Building, Daneshgah street
City
Mashhad
Postal code
-
Approval date
2015-12-27, 1394/10/06
Ethics committee reference number
IR.MUMS.REC.1394.610

Health conditions studied

1

Description of health condition studied
Healthy volunteers
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Biochemical factors
Timepoint
Before and one month after intervention
Method of measurement
Device analysis

2

Description
hormonal factors
Timepoint
Before and one month after intervention
Method of measurement
Device analysiis

3

Description
Blood factors
Timepoint
Befor and one month after intervention
Method of measurement
Device analysis

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Carvacrol, Capsules cantain 30 mg carvacrol, three times per day for one month
Category
Treatment - Drugs

2

Description
Carvacrol, Capsules cantain 47 mg carvacrol, three times per day for one month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Vahideh Ghorani Sirjani
Street address
School of Medicine, Ferdowsi university campuse, Azadi Square
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
Department of pharmaceutics and panotechnology, School of Pharmacy, Ferdowsi university campuse, Azadi Square
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
Vahideh Ghorani Sirjani
Position
Pharmaceutical Sciences PhD Student
Other areas of specialty/work
Street address
Department of physiology, School of Medicine, Ferdowsi university campuse, Azadi Square
City
Mashhad
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
+98 38828560
Email
Ghoranisv921@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Hossein Boskabady
Position
MD, PhD physiology
Other areas of specialty/work
Street address
Department of physiology, School of Medicine, Ferdowsi University Campuse, Azadi Square
City
Mashhad
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
+98 38828560
Email
Boskabadymh@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahideh Ghorani Sirjani
Position
Pharmaceutical Sciences PhD Student
Other areas of specialty/work
Street address
Department of physiology, School of Medicine, Ferdowsi University Campuse, Azadi Square
City
Mashhad
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
+98 38828560
Email
Ghoranisv921@mums.ac.ir
Web page address
www.mums.ac.ir

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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