Protocol summary

Summary
The aim of this study is to assess the Satureja hortensis effects on metabolic syndrome. Inclusion criteria comprises: waist circumference for men ≥ 102cm and for women ≥ 88cm, fasting blood glucose ≥ 110 mg/dl, HDL-cholesterol for men < 40 mg/dl and for women < 50 mg/dl, Triglycerides ≥ 150 mg/dl, Blood pressure ≥ 130/85 mm Hg. Exclusion criteria also considered as: liver dysfunction; smoking; kidney disorder; consumption of NSAIDs and incidence of any inflammatory disease. This double-blind randomized controlled clinical trial will be done on 60 metabolic syndrome patients (30 for placebo and 30 for intervention group) referred to Shiraz Imam Reza hospital for 7 weeks. Patient selection will be done by a third party in form of simple randomization in two groups of 1 or 2 (placebo or intervention). The patients' codes and group numbers will remain with the third party until the end of study when they will be used for analysis. Measurement of serum levels of glucose, LDL-cholesterol, HDL-cholesterol, triglyceride, hs-CRP and blood pressure will be done at the beginning of the study before treatment. Also at the end of study in day 70 after intervention with Satureja hortensis dry leaf 450 mg in a capsule per day in intervention group and placebo 450 mg in a capsule per day in placebo group, serum levels of aforementioned parameters will be measured again. Data obtained from measurements before and after intervention in both groups will be compared by SPSS software analyzing.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012616372N1
Registration date: 2014-02-26, 1392/12/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-26, 1392/12/07
Registrant information
Name
Farzad Nikaein
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1726 2850
Email address
nikaeinf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vise Chancellor for Research Affairs, Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-04, 1392/05/13
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Satureja hortensis effect on serum glucose, LDL-cholesterol, HDL-cholesterol, triglyceride, hs-CRP and blood pressure in metabolic syndrome patients.
Public title
Satureja hortensis effect on serum glucose, lipids, inflammatory factor and blood pressure in metabolic syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Waist circumference men ≥ 102cm or 40in and women ≥ 88cm or 35in, Fasting blood glucose ≥ 110 mg/dl, HDL-cholesterol for men < 40 mg/dl and for women < 50 mg/dl, Triglycerides ≥ 150 mg/dl, Blood pressure ≥ 130/85 mm Hg. Exclusion criteria: hypothyroidism; alcoholism; smoking; auto immune disease; chronic pancreatitis; liver dysfunction; kidney disorder or nephritic syndrome; simultaneous subscription in other interventional study; any inflammatory disease or incidence of infection at start or during the study period; consumption of other drug such as aspirin, propranolol, NSAIDs, any form of steroids and any kind of blood glucose and lipid lowering agent; angioplasty or heart attack positive history; pregnancy and lactating.
Age
From 30 years old
Gender
Both
Phase
3
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Commitee
Street address
Shiraz University of Medical Sciences Ethics Commitee, Zand st., Shiraz, Iran
City
Shiraz
Postal code
Approval date
2013-09-28, 1392/07/06
Ethics committee reference number
92-6707

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified

Primary outcomes

1

Description
Fasting Blood Glucose
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
Laboratory kit, Pars Azmoon

2

Description
LDL-cholesterol
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
Laboratory kit, Pars Azmoon

3

Description
High sensetive- C Reactive Protein
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
Laboratory kit, Pars Azmoon

4

Description
Blood Pressure (systolic and diastolic)
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
Beurer Upper Arm Digital Blood Pressure Monitor

5

Description
HDL-cholesterol
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
Laboratory kit, Pars Azmoon

6

Description
Triglyceride
Timepoint
Begining of study first day and at the end of study 70th dayBegining and end of study
Method of measurement
Laboratory kit, Pars Azmoon

Secondary outcomes

1

Description
Alanine Aminotransferase
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
Laboratory kit, Pars Azmoon

2

Description
Aspartate Aminotransferase
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
Laboratory kit, Pars Azmoon

3

Description
Complete Blood Count
Timepoint
Begining of study first day and at the end of study 70th day
Method of measurement
CBC counter machine, Sysmex

Intervention groups

1

Description
Intervention group: Satureja hortensis dry leaf 450 mg in a capsule per day for 70 days
Category
Treatment - Drugs

2

Description
Control group: Starch and green edible color 450 mg in a capsule per day for 70 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Healthy Heart Institute
Full name of responsible person
Mrs. Maryam Rezaei
Street address
Healthy Heart Institute, Fazilat St., Modares Blvd., Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Full name of responsible person
Dr. Ali Poostforush
Street address
Vice Chancellor for Research Affairs, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
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
School of Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Farzad Nikaein
Position
Msc. Candidate for Nutrition
Other areas of specialty/work
Street address
School of Nutrition, Razi blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1726 2850
Fax
Email
nikaeinf@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Siavash Babajafari
Position
Professor Assistant
Other areas of specialty/work
Street address
School of Nutrition, Razi Blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1726 2850
Fax
Email
jafaris@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Farzad Nikaein
Position
Msc. Candidate for Nutrition
Other areas of specialty/work
Street address
School of Nutrition, Razi blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1726 2850
Fax
Email
nikaeinf@sums.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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