This study is a randomized double blind clinical trial. This study is performed on patients referred to the institute of Endocrinology and Metabolism of Tehran University of Medical Sciences and were selected after getting a written consent and inclusion criteria .Randomly, 40 patients were selected as the intervention group and 40 of them were selected as control group. Intervention group received daily,2/400gram of turmeric powder in the form of 3 capsules (800mg) and placebo group received 2/400 gram corn starch in the form of 3 capsules 800mg daily. Intervention period in this study was 8 weeks. Before and after the intervention, blood samples were taken from all the volunteers. So that the possible changes in glycemic status, lipid parameters, CRP and total serum antioxidant capacity (TAC) will be studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204162602N7
Registration date:2012-05-12, 1391/02/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-12, 1391/02/23
Registrant information
Name
Shahryar Eghtesadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
egtesadi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tehran university of Medical Sciences
Expected recruitment start date
2012-06-20, 1391/03/31
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Turmeric on blood Indicators and blood pressure in hyperlipidemic type 2 diabetes mellitus patients
Public title
The effect of Turmeric on blood Indicators and blood pressure in hyperlipidemic type 2 diabetes mellitus patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; People with type 2 diabetes; Aged people with 30 to 70 years of age; Aged people with 30 to 70 years of age; People having HbA1c above 6; Patients with TG>150mg/dl, LDL above 100mg/dl; Lack of consumption of multivitamin; supplements, antioxidants, polyphenols, since last three months;
BMI 20 – 35 .
Exclusion criteria of the study: Participants of the study under treatment had no changes in consumption of medicine; Patients having fasting blood glucose >200mg/dl or LDL>160mg/dl were excluded from the study; Changes in dose and type of medication;
Inclusion criteria for the study: Acute cardiac disease, renal failure, liver and thyroid disease; Rejection of turmeric powder supplement.
actation or pregnancy; Severe gastrointestinal disease and gastric ulcers; Risk of gall stones Changes in physical activity and diet;
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tehran University of Medical Sciences
Street address
Sixth Floor,Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-04-08, 1391/01/20
Ethics committee reference number
2581/130/د/90
Health conditions studied
1
Description of health condition studied
hyperlipidemic type 2 diabetes mellitus patients
ICD-10 code
E11,E12,E1
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
8 weeks
Method of measurement
sphygmomanometer
2
Description
Diastolic blood pressure
Timepoint
8 weeks
Method of measurement
sphygmomanometer
3
Description
FBS
Timepoint
8 week
Method of measurement
Laboratory kit
4
Description
Fasting Insulin
Timepoint
8 week
Method of measurement
Laboratory kit
5
Description
HbA1C
Timepoint
8 weeks
Method of measurement
Laboratory kit
6
Description
Triglyceride (TG)
Timepoint
8 weeks
Method of measurement
Laboratory kit
7
Description
Total Cholesterol (TC)
Timepoint
8 weeks
Method of measurement
Laboratory kit
8
Description
LDL
Timepoint
8 weeks
Method of measurement
Laboratory Kit
9
Description
HDL
Timepoint
8 weeks
Method of measurement
Laboratory Kit
10
Description
Apo A-I
Timepoint
8 weeks
Method of measurement
Laboratory Kit
11
Description
Apo B-100
Timepoint
8 weeks
Method of measurement
Laboratory kit
12
Description
CRP
Timepoint
8 weeks
Method of measurement
Laboratory kit
13
Description
TAC
Timepoint
8 weeks
Method of measurement
Laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
group receiving turmeric:capsules containing 800mg turmeric, three a day for 8 weeks
Category
Treatment - Drugs
2
Description
placebo group receiving :capsules containing 800mg of corn starch, three a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Institute of Endocrinology & Metabolism of Tehran University of Medical Sciences
Full name of responsible person
Dr Iraj Hidari
Street address
Taleghani Hospital, Vali Asr Avenue intersection above Fyrzgr
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Research section , Tehran University of Medical Sciences, Ghods st, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
school of health tehran university of medicalSciences
Full name of responsible person
Zohreh Adab
Position
Student Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition, Health school, Tehran University of Medical Sciences, Alvand st., Argentine Square, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
Zohre_adab2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahriar Eghtesadi
Position
PhD of Nutrition sciences
Other areas of specialty/work
Street address
Department of Nutrition, Health school, Tehran University of Medical Sciences, Alvand st., Argentine Square, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
egtesadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Health. Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahriar Eghtesadi
Position
Professor
Other areas of specialty/work
Street address
School of Health, Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
egtesadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)