1. Home
  2. Approved trials
  3. » فارسی

study of the effect of coriander seed supplementation on the control of glycemic indices ,lipid profile and oxidant / antioxidant status in type 2 diabetic patients: Randomized controlled clinical trial

Protocol summary

Study aim
Determination of Coriander Seed Effects on Glycemic Indicators, Lipid Profile and Oxidant / Antioxidant Status in Type 2 Diabetic Patients
Design
Double-blind, randomized controlled clinical trials
Settings and conduct
Patients referred to the Diabetes Clinic of Sina Hospital in Tabriz are selected according to exit criteria. All subjects participating in the study will be taken after a 12-hour fasting blood sample. The specimen will be stored at Freeze-70 until the second test. After 6 weeks of intervention, blood samples will be taken from patients again. The randomized sampling method is simple. A double-blind study, which neither the patient nor the one in charge of the capsule provides them, will not be aware of the type of capsule.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Diabetic patients 30 to 60 years old, having diabetes for more than 3 years, satisfaction to participate in the project Exit criteria: - Smokers, pregnant, lactating, people with complex thyroid disorders, liver, digestive, cardiovascular, renal and ineffective immune systems, consumers of non-steroidal anti-inflammatory drugs and those who are homoeopathic, consumers of antioxidant supplements in the last three months , Non-controlled type 2 diabetic patients and insulin-dependent diabetic patients
Intervention groups
Coriander seed supplement
Main outcome variables
Fasting serum insulin levels, fasting blood glucose, insulin resistance, lipid profile (TC, HDL-C, TG, LDL-C), serum levels of MDA and TAC

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190224042821N2
Registration date: 2019-10-11, 1398/07/19
Registration timing: prospective

Last update: 2019-10-11, 1398/07/19
Update count: 0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
Ali Barzegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
barzegarali@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the effect of coriander seed supplementation on the control of glycemic indices ,lipid profile and oxidant / antioxidant status in type 2 diabetic patients: Randomized controlled clinical trial
Public title
coriander seed supplementation in diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients 30 to 60 years old Having diabetes for over 3 years Satisfaction to participate in the project
Exclusion criteria:
Smokers, pregnant, lactating - People with complex thyroid disorders, liver, digestive, cardiovascular, renal and ineffective immune system Consumers of nonsteroidal anti-inflammatory drugs and those who are homoeopathic Antioxidant supplement supplements in the last three monthsAntioxidant supplement supplements in the last three months Uncontrolled type 2 diabetes and diabetic patients receiving insulin
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Diabetic patients referred to the Sina Diabetes Clinic who had a medical record in this center and were eligible for inclusion were explained about the plan. Individuals who were willing to participate in the project were randomly divided into case and control groups based on their case number and individual number.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications and placebo were coded so that no scholars or participants were reported
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciencesه
Street address
Tabriz University of Medical Sciences,Attar Neyshaburi Ave, Golgasht Ave
City
tabriz
Province
East Azarbaijan
Postal code
5166/1573113
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.TBZMED.REC.1398.677

Health conditions studied

1

Description of health condition studied
type 2 diabets
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Blood glucose
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic methods

2

Description
Lipid profile
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of total cholesterol, triglyceride and HDL by enzymatic methods and calculation of LDL cholesterol by Friedewald formula

3

Description
Oxidant and antioxidant
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of total antioxidant capacity by colorimetric method and malondialdehyde by TBARS method

4

Description
Blood insulin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA

5

Description
Insulin resistance
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of insulin resistance by Homa-IR method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Two daily capsules of coriander seed supplements prepared from Baharan Tabriz Company (500 mg). It will be half an hour before lunch and dinner and for 6 weeks
Category
Treatment - Drugs

2

Description
Control group: Two daily capsules of corn starch prepared from Baharan Tabriz Company (500 mg). It will be half an hour before lunch and dinner and for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital Tabriz. (Diabetes Clinic) using the recall
Full name of responsible person
Dr. Rafat Zanbouiri
Street address
Sina Hospital, Azadi St
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 1300
Email
dr.r.zanbouri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrangiz Ebrahimi Mamaghani
Street address
Tabriz. Gulgasht Street Tabriz University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
6987512345
Phone
+98 41 3356 7973
Email
ebrahimimamagani@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5489624763
Phone
+98 41335789532
Email
Alibarzegar@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz. Gulgasht Street Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5896371459
Phone
+98 41337899583
Email
Alibarzegar@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz. Gulgasht Street Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
7852369421
Phone
+98 41 3375 9862
Email
Alibarzegar@hotmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main implications will be shared.
When the data will become available and for how long
Start the access period 12 months after printing the results
To whom data/document is available
The data will only be available to people working in scientific institutions.
Under which criteria data/document could be used
The study data will be available to other researchers only for meta-analysis studies.
From where data/document is obtainable
To access the required data, researchers can contact Dr. Ali Barzegar: Telephone: 09143116148 Email Address:Alibarzegar@hotmail.com
What processes are involved for a request to access data/document
The applicant must provide a brief explanation of the goals and methodology of his meta-analysis study. Applicants will be investigated by the researchers, and if they all agree, the requested data will be sent to the applicant by email and in Excel file format. All these steps will not last more than 15 days.
Comments
Loading...