This study is carried out the effect of alcoholic Hibiscus tea extract on lipid profiles, markers of oxidative stress and inflammatory factors, hs-CRP in patients with type 2 diabetes in a randomized double-blind clinical trial in Research Center of Biochemistry and Nutrition in Metabolic Diseases, Medical University of Kashan. A total of 60 patients with type 2 diabetes selected with criteria and were randomized to either an intervention group(n = 30) and control(n = 30). After obtaining informed consent from the patient, a demographic, medical, and a 24-hour dietary recall (to determine energy and nutrient intake of patients) should be completed for each patient. Before the intervention, all patients were measured in fasting blood samples. During the study, the patients are advised not to alter their diet and activity. Because of this study is double-blind, the total package by someone other than the researcher and the patients are encoded. At the end of the study, blood samples will be collected again to measure variables .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212251576N2
Registration date:2012-12-29, 1391/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-29, 1391/10/09
Registrant information
Name
Ali Akbar Rshidi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
rashidi@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences and Barij Essence CO.
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of alcoholic extract of hibiscus sabdariffa on lipid profiles, oxidative stress markers and hs-CRP in type 2 diabetic patients
Public title
Effect of alcoholic extract of hibiscus sabdariffa on lipids and inflammatory markers in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: HbA1c < 8%; LDL < 130 mg/dl; TG< 300 mg/dl; no liver and kidney disease and no concemption of lipid lowering drugs.
Exclusion criteria: Hibiscus tea sensivity; unwillingness to continue the study; insulin usage and change the dose of hypoglycemic drugs during the study.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
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
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, ghotb Ravandi BLV, Kashan
City
Kashan
Postal code
Approval date
2012-12-08, 1391/09/18
Ethics committee reference number
9188
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Glucose
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
mg/dl
2
Description
HbA1c
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
%
3
Description
Total cholesterol
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
mg/dl
4
Description
LDL and HDL cholesterol
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
mg/dl
5
Description
Triglycerides
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
mg/dl
6
Description
Total antioxidants
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
mmol/l
7
Description
hs-CRP
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
ng/ml
Secondary outcomes
1
Description
ALT and AST
Timepoint
Befor intervention and 3 months after intervention
Method of measurement
mg/dl
Intervention groups
1
Description
Control group recived placebo(corn starch) 3 tablet daily for 3 month
Category
Placebo
2
Description
Intervention group: recived 3 Hyporex-B tablet daiy that contain alcoholic extract of Hibiscuc sabdariffa for 3 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Diabetes Center
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Kashan University of Medical Sciences
Full name of responsible person
Somayyeh Nadi
Street address
Ghotb Ravandi BLV, Kashan University of Medical Sciences, Kashan.
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Ali Akbar Rashidi
Position
MSc in Nutrition
Other areas of specialty/work
Street address
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan.
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
rashidi@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatola Asemi
Position
PhD in Nutrition
Other areas of specialty/work
Street address
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
asemi@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Akbar Rashidi
Position
MSc in Nutrition
Other areas of specialty/work
Street address
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)