1. Home
  2. Approved trials
  3. » فارسی

Measurement of Crostin serum level after administration of Crocina tablet using HPLC technique

Protocol summary

Study aim
Measurement of Crostin serum level after administration of 15mg Crocina
Design
Field trial, pragmatic, without blinding.
Settings and conduct
After obtaining informed consent, one crocin tablet made by Sami Saz company containing 15 mg of crocin will be administered orally during the trial to 5 healthy male volunteers. In the next step, blood sampling will be done at 0, 30, 60, 90, 120, 180 and 240 minutes after drug administration. blood serum will be separated with a centrifuge at 5000 rpm for 20 minutes. In the next step, crostin is extracted from the serum and prepared for injection into the HPLC device. Analysis of crostin in blood will be done by HPLC. The concentration curve will be drawn in terms of time, and the pharmacokinetic parameters including the maximum concentration, the time required to reach the maximum concentration, the area under the concentration graph in terms of time and the half-life time will be calculated.
Participants/Inclusion and exclusion criteria
Entry conditions: Patient willingness to participate in the study, Age above 18 years, No addiction to narcotics and sedatives and alcohol, No history of mental illness, not using anticoagulants, Absence of diabetes, Absence of underlying disease; Non-entry conditions: Hemodynamic instability in participant, history of, Cardiopulmonary resuscitation in participant, past medical history of admission in the intensive care unit, abnormal liver tests ( AST، ALT، CBC ), abnormal kidney tests ( U/A، BUN، Cr )
Intervention groups
One tablet of Crocina (15 mg) made by Samisaz Company is given orally to healthy people who do not take any other medicine.
Main outcome variables
blood concentration of crocetin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130507013263N2
Registration date: 2022-08-19, 1401/05/28
Registration timing: registered_while_recruiting

Last update: 2022-08-19, 1401/05/28
Update count: 0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
hadizadehf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Measurement of Crostin serum level after administration of Crocina tablet using HPLC technique
Public title
Measurement of Crostin serum level after administration of Crocina tablet using HPLC technique
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Patient willingness to participate in the study Age above 18 years No addiction to narcotics, sedatives and alcohol No history of mental illness, no use of anticoagulants Absence of diabetes Absence of underlying disease
Exclusion criteria:
Hemodynamic instability in participant history of Cardiopulmonary resuscitation in participant past medical history of admission in the intensive care unit abnormal liver tests ( AST، ALT، CBC ) abnormal kidney tests ( U/A، BUN، Cr )
Age
From 18 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Mashhad University of Medical Sciences
Street address
school of Pharmacy, Mashhad University of Medical Sciences, Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.MUMS.REC.1401.016

Health conditions studied

1

Description of health condition studied
Evaluation of the concentration-time curve of the a Crostin in healthy people
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of crostin blood concentration
Timepoint
Blood sampling will be done at 0, 30, 60, 90, 120, 180 and 240 minutes after drug administration.
Method of measurement
Determination of crostin blood concentration by HPLC (High-performance liquid chromatography) system

Secondary outcomes

empty

Intervention groups

1

Description
Administration of one crocin tablet made by Samisaz company containing 15 mg of crocin orally.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Pharmacy, Mashhad
Full name of responsible person
Farzin Hadizadeh
Street address
School of Pharmacy, Campus of University, Azadi Sq., Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1128
Fax
+98 51 3882 3251
Email
hadizadehf@mums.ac.ir
Web page address
https://medchimdept.mums.ac.ir/member/aza-group

Sponsors / Funding sources

1

Sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
empty
Title of funding source
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzin Hadizadeh
Street address
School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1128
Fax
+98 51 3180 1128
Email
hadizadehf@mums.ac.ir
Grant name
Grant code / Reference number
4001501
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farzin Hadizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1128
Email
hadizadehf@mums.ac.ir
Web page address
https://medchimdept.mums.ac.ir/member/aza-group

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzin Hadizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1128
Email
hadizadehf@mums.ac.ir
Web page address
https://medchimdept.mums.ac.ir/member/aza-group

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzin Hadizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1128
Email
hadizadehf@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Co-worker of proposal. Hossein Kamali and Faezeh Ghorbanzadeh and Mojgan Nejabat
Under which criteria data/document could be used
-
From where data/document is obtainable
Refer to me Farzin Hadizadeh. contact us: hadizadehf@mums.ac.ir
What processes are involved for a request to access data/document
-
Comments
-
Loading...