The purpose of this research is to study of therapeutic effect of curcumin on patients with Metabolic syndrome. In this double blind randomized clinical trial, 100 patients with Metabolic syndrome will be divided in two groups. For 12 weeks, in addition to routine treatments, treat by curcumin capsule (500 mg daily) or placebo. Lipid profile, Fasting Blood Sugar, Hemoglobin A1C, Interleukin 8, Interleukin 6, leptin and Adiponectine are measured before and after study and results of lab tests are compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512181165N12
Registration date:2017-10-27, 1396/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiyatallah University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of curcumin effect on patients with Metabolic syndrome
Public title
Effect of curcumin (tumeric) on patients with Metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with metabolic syndrome; Sign informed consent
Exclusion Criteria: Discontinue of treatment for more than One week; Allergic reaction to herbal compounds; Abnormal results in lab tests
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized, double blinded and control with placebo
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University
Street address
Yasaman alley, Yakhchal steet, Shariati street
City
Tehran
Postal code
Approval date
2015-09-16, 1394/06/25
Ethics committee reference number
IR.IAU.PS.REC.1394.25
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E89.8
ICD-10 code description
Other postprocedural endocrine and metabolic disorder
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
mmHg
2
Description
FBS
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
mg/dl
3
Description
TG
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
mg/dl
4
Description
HDL
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
mg/dl
5
Description
LDL
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
mg/dl
6
Description
Small Density LDL
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
mg/dl
7
Description
Interleukin 8
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
Level of serum
8
Description
Interleukin 6
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
Level of serum
9
Description
Hb A1C
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
Level of serum
10
Description
Leptin
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
ng/ml
11
Description
Adiponectin
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
ng/ml
12
Description
Leptin/Adiponectin Ratio
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
Ratio
Secondary outcomes
1
Description
Body Mass Index (BMI)
Timepoint
Before and after of intervention (12 weeks)
Method of measurement
Kg/m2
Intervention groups
1
Description
Intervention group: Curcumin capsule, once a day for 3 months
Category
Treatment - Drugs
2
Description
Control group: Placebo of curcumin, once a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Baqiyatallah Hospital
Full name of responsible person
Dr. Yunes Panahi
Street address
Mollasadra Street, Vanak Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baghiyatallah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Street address
Mollasadra Street, Vanak Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiyatallah 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
Pharmaceutical Sciences Branch Islamic Azad University
Full name of responsible person
Niloufar Torabi
Position
Pharm.D
Other areas of specialty/work
Street address
Yakhchal Street, Gholhak, Shariati Street
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
y_niloo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baghiyatallah University of Medical Sciences, Chemical Injeries Research Center
Full name of responsible person
Dr. Yunes Panahi
Position
Ph.D of clinical Pharmacy
Other areas of specialty/work
Street address
Mollasadra street, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
yunespanahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)