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the effect of crocin on fasting blood sugar, lipid profile, inflammatory cytokines, pro-oxidants-antioxidants balance, depression and anxiety in the patients with metabolic syndrome

Protocol summary

Summary
The purpose of this study is to evaluate the effectiveness of crocin in patients with metabolic disorders. This is a 8-week randomized and double-blind placebo controlled clinical trial. Sixty adult patients who will be diagnosed with early stage metabolic syndrome based on AHA 2009 guidelines will be randomly assigned into crocin (15 mg/BID) or control (placebo/BID) group. At the first visit for intervention study and end of treatment course, a blood sample will be drawn and the following factors will be measured; lipid profile ( LDL, TG, TC, HDL level), fasting blood sugar (FBS), inflammatory cytokines, including TNF-α, VEGF, EGF, INF-γ, and IL1-α, IL1-β, IL2, IL4, IL6, IL8, IL10, MCP-I and antibody HSP27 , pro-oxidants- antioxidants balance (PAB) and genetic and novel biomarkers of cardio - vascular disorders. In addition, the effect of crocin on the depression and anxiety of the subjects will be investigated. The crocin tablets contain 15 mg crocin (active ingredient), and Lactose and Avicel (as excipients). placebo has no crocin. The tablets are administered orally twice daily for eight weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013080514279N1
Registration date: 2015-02-01, 1393/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-01, 1393/11/12
Registrant information
Name
Mojtaba Foroutan Tanha
Name of organization / entity
Medical University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 3255
Email address
foroutantm851@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2014-04-06, 1393/01/17
Expected recruitment end date
2014-06-28, 1393/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of crocin on fasting blood sugar, lipid profile, inflammatory cytokines, pro-oxidants-antioxidants balance, depression and anxiety in the patients with metabolic syndrome
Public title
the effect of crocin on patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the desire to participate in the study; having no previous history of angiography; having no order of emergency angiography; having 20 number anxiety; age over 18 years old;; health in the legs and hands; patients not taking the narcotic drug alcohol, ; having no previous history of mental disorder; not using anticoagulation medications; No diabetes; Do not have the risk of deep vein thrombosis. Exclusion criteria: injury or infection at the site of reflex zone therapy; anxiolytic or hypnotic drugs in the 8 hours before reflex zone therapy; condition of hemodynamic is unstable; transfer of patient to intensive care unit and cardiopulmonary resuscitation of the patient
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The subjects who entered the trial, chose a numbered sealed envelope containing the randomized allocation to the intervention or control group. All subjects gave written informed consent before beginning the study.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
The Regional Committee for Ethics in Research, Mashhad University of Medical Sciences
Street address
Qureshi Building, Daneshagh Street
City
Mashhad
Postal code
Approval date
2013-11-02, 1392/08/11
Ethics committee reference number
920782

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
Lipid profiles
Timepoint
Before the intervention, and 8 weeks after the intervention
Method of measurement
Laboratory analysis of the blood samples taken before the intervention and 8 weeks after the commencement of the intervention

2

Description
inflammatory cytokines
Timepoint
Before the intervention, and 8 weeks after the intervention
Method of measurement
Laboratory analysis of the blood samples taken before the intervention and 8 weeks after the commencement of the intervention

3

Description
Fast blood sugar (FBS)
Timepoint
Before the intervention, and 8 weeks after the intervention
Method of measurement
Laboratory analysis of the blood samples taken before the intervention and 8 weeks after the commencement of the intervention

4

Description
pro-oxidants- antioxidants balance (PAB)
Timepoint
Before the intervention, and 8 weeks after the intervention
Method of measurement
Laboratory analysis of the blood samples taken before the intervention and 8 weeks after the commencement of the intervention

5

Description
depression and anxiety
Timepoint
Before the intervention, and 8 weeks after the intervention
Method of measurement
Analysis of the questionnaires filled before the intervention and 8 weeks after the commencement of the intervention

6

Description
Antibody HSP27
Timepoint
Before the intervention, and 8 weeks after the intervention
Method of measurement
Laboratory analysis of the blood samples taken before the intervention and 8 weeks after the commencement of the intervention

Secondary outcomes

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Intervention groups

1

Description
Patients in the intervention group receive 2 oral pills/day containing 15 mg of crocin for 8 consecutive weeks. Crocin is a carotenoid, which is isolated and purified from the extract of saffron.
Category
Treatment - Drugs

2

Description
Patients in the control group receive 2 oral placebo pills/day for consecutive 8 weeks. placebo has no crocin and look like the crocin tablets.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
Shariati Square, Ahmadabad Street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
School of Pharmacy, Mashhad University of Medical Sciences, 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
Research Council of 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 Matin Khademi
Position
Pharmacy student
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3764 3188
Fax
Email
Khademim861@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzin Hadizadeh
Position
PhD
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Postal code
91775-1365
Phone
+98 51 3882 3255
Fax
Email
HadizadehF@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
Mojtaba Foroutan Tanha
Position
Pharmacy student
Other areas of specialty/work
Street address
no 6, Modarress 67, Modarress street
City
Birjand
Postal code
9718717673
Phone
+98 56 1444 5434
Fax
Email
Foroutantm851@mums.ac.ir
Web page address

Sharing plan

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