Protocol summary

Summary
The purpose of this clinical trial to evaluate the effects of sour tea on metabolic syndrome Inclusion criteria:Patients with metabolic syndrome according to the criteria of panel The Adult Treatment Panel III (ATP III) treatment groups were 2005 adults.These criteria include having 3 of the 5 criteria: Abdominal obesity (waist circumference more 102 cm in men and than 88 cm In women );Decrease in plasma HDL-C (men less than 40 mg/dl and in women less than 50 mg/dl); Plasma hypertriglyceridemia (greater than 150 mg/dl); Hypertension (systolic blood pressure greater than or equal to 130 mm Hg or diastolic blood pressure greater than or equal to 85 mm Hg);And abnormal blood glucose (fasting blood glucose equal to or greater than 100). 40 patients with metabolic syndrome than 18 years will berandomly divided into two treatment groups and control. In the group of patients treated take a daily capsule of hibiscus tea after breakfast, for a month. At the beginning and end of a month of blood samples for determination of total cholesterol, HDL, LDL, TG, VLDL, Apo-A, Apo-B, FBS, insulin, hs-CRP and serum malondialdehyde (MDA). Also, BP and BMI were recorded and used to determine the possible effect of the drug on liver and renal function, serum urea and creatinine levels, as well as Cr and ALT and AST liver enzymes to be determined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310089662N8
Registration date: 2013-12-04, 1392/09/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Sedigheh Asgary
Name of organization / entity
Isfahan Cardiovascular Research Center ,Isfahan Cardiovascular Research institute , Physiology Re
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9090
Email address
s_asgari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
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
Evaluation of the effects of Hibiscus sabdariffa on lipid profile, insulin resistance, oxidative stress, and hs-CRP level in adult patients with metabolic syndrome
Public title
Evaluation of the effects of sour tea on lipid profile, insulin resistance, oxidative stress, and inflammatory markers in adult patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with metabolic syndrome according to the criteria of panel The Adult Treatment Panel III (ATP III) treatment groups were 2005 adults.These criteria include having 3 of the 5 criteria: Abdominal obesity (waist circumference more 102 cm in men and than 88 cm In women );Decrease in plasma HDL-C (men less than 40 mg/dl and in women less than 50 mg/dl); Plasma hypertriglyceridemia (greater than 150 mg/dl); Hypertension (systolic blood pressure greater than or equal to 130 mm Hg or diastolic blood pressure greater than or equal to 85 mm Hg);And abnormal blood glucose (fasting blood glucose equal to or greater than 100). exclusion criteria:People with diseases such as diabetes type 1 or 2;Thyroid disorders; nephrotic syndrome; Liver or kidney disease;Insulin, oral antidiabetic drugs;Drugs which affect blood lipid levels, such as statins;Oral contraceptive pills, hormones such as estrogen and progesterone;Smoking, alcohol and drugs;Pregnancy and lactation; drug allergy.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar jirib St. Isfahan Isfahan, Iran, Islamic Republic Of
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
391169

Health conditions studied

1

Description of health condition studied
metabolic syndrome
ICD-10 code
E78.8
ICD-10 code description
Other disorders of lipoprotein metabolism

Primary outcomes

1

Description
low-density lipoprotein (LDL)
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

2

Description
Triglyceride (TG)
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

3

Description
Total cholesterol (TC)
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

4

Description
high-density Lipoprotein(HDL)
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

5

Description
VLDL
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

6

Description
Apo-A
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

7

Description
َApo- B
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

8

Description
Insulin
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

9

Description
FBS
Timepoint
Baseline and one month after intervention
Method of measurement
mg/dL - enzymatic - photometric

10

Description
hs-CRP
Timepoint
Baseline and one month after intervention
Method of measurement
ng/dl/ Elisa

11

Description
MDA
Timepoint
Baseline and one month after intervention
Method of measurement
ng/dl/ Elisa

Secondary outcomes

1

Description
BMI
Timepoint
Baseline and one month after intervention
Method of measurement
W/M2

Intervention groups

1

Description
In group 1 capsule daily treatment will sour tea. Once a day after breakfast
Category
Treatment - Drugs

2

Description
In the control group taking placebo capsules daily, after breakfast
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Mahtab Keshvari
Street address
Khorram Street, Jomhori Square
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Gholam Hossin Sadri
Street address
Hezar jirib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Cardiovascular Research Center, Applied Physiology Research Center, Isfahan University of Me
Full name of responsible person
Sedigheh Asgary
Position
Pharmacist and PhD Pharmacogenetics
Other areas of specialty/work
Street address
Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31 1335 9090
Fax
Email
sasgary@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Zolghadr
Position
md Pharmacist
Other areas of specialty/work
Street address
Hezar jirib st.
City
Isfahan
Postal code
Phone
+98 31 1335 9090
Fax
Email
zolghadr.mohsen@yahoo.com
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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