Protocol summary

Summary
In this double blind clinical trial study, both the investigator or the participant are blind to the nature of the treatment, the participant is receiving . 160 patients from Isfahan diabetes clinic after interview and completing satisfaction's form and according to the entry and exit criteria (Entrance scale: diabetics and range of age 30 up to 50/ Exit scale: smoking, having the underlying disease and other metabolic disorders, alcohol consumption, consumption of other supplements and drugs)will be selected and will be divided to four groups, randomly. All patients during the study,will consume their prescribed drug (Metformin) according to the routine procedure , the first group will receive the extract of Cumin, second group will receive the Rezvin supplement and third group will receive Vitamin c. Fourth group as control group will receive placebo (oral gelatin capsules). At the beginning of the study and after 60 days ( consuming supplements in each group) , from all groups participants , 10 CC of venous blood in fasting status will be taken. On samples, FBS beside tests for Lipid profile, Apo A , Apo B, Gamma glutamyl transferase, Iron ,HBA1c, Glutathione peroxidase, Superoxide dismutase, Glutathione reductase, and Xanthine oxidase, Ghrelin, Paraoxonase, Total antioxidant capacity , MDA, Glutathione will be measured. We hope with affirmation of the assumptions,we could see an improvement by using natural antioxidant supplements and herbal products to deal with the destructive effects of Free radicals and oxidative stress in Diabetic patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100619420N1
Registration date: 2014-11-21, 1393/08/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-21, 1393/08/30
Registrant information
Name
Mohammad Hosein Gharib
Name of organization / entity
Shahrekord University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 3661 9867
Email address
mohogharib@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahrekord University of Medical Science
Expected recruitment start date
2014-11-06, 1393/08/15
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cuminum cyminum extract, Resvin and Vitamin C on Antioxidant parameters, Lipids profile , Ghrelin and several biochemical indices in type 2 Diabetic patients
Public title
Effect of Cuminum cyminum extract, Resvin and Vitamin C in type 2 Diabetic patients
Purpose
Other
Inclusion/Exclusion criteria
inclusion criteria:Diabetic patient, range of age 30 up to 50 exclusion criteria :smoking, alcoholic patient,have another metabolic or outline disease; use of other drugs or supplements
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
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
Morals committee of Shahrekord University of Medical Science
Street address
Morals committee of Shahrekord University of Medical Science, Shahrekord University of Medical Science, Rahmatieh, Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
1393-8-29

Health conditions studied

1

Description of health condition studied
Diabetics type 2
ICD-10 code
E11
ICD-10 code description
Non insulin dependent diabetes mellitus

Primary outcomes

1

Description
Total antioxidant capacity
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

2

Description
Ghrelin
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

Secondary outcomes

1

Description
Cholestrol
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

2

Description
Glucose
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

3

Description
Triglyceride
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

4

Description
HDL
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

5

Description
LDL
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

6

Description
Apo A
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

7

Description
Apo B
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

8

Description
Fe
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

9

Description
Weight
Timepoint
before intervention and 2 month after intervention
Method of measurement
standard scale

10

Description
Blood pressure
Timepoint
before intervention and 2 month after intervention
Method of measurement
standard barometer

11

Description
HbA1c
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

12

Description
Gamma glutamyl transferase
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

13

Description
Paraoxonase
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

14

Description
Superoxide dismutase
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

15

Description
Glutathione peroxidase
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

16

Description
Xanthine oxidase
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

17

Description
Glutathione reductase
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

18

Description
Glutathione
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

19

Description
MDA
Timepoint
before intervention and 2 month after intervention
Method of measurement
blood analysis

Intervention groups

1

Description
Intervention group: Cumin extract, 15 mg/kg/day, oral, during 60days
Category
Treatment - Drugs

2

Description
Intervention group: Rezvin, 10mg/kg/day, oral, during 60 days
Category
Treatment - Drugs

3

Description
Intervention group: VitC, 500 mg/day, oral, during 60 days
Category
Treatment - Drugs

4

Description
control group: Placebo, one Capsule per day, oral, during 60 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord University of Medical Science
Full name of responsible person
Mohammad Hosein Gharib
Street address
Shahrekord University of Medical Science, Rahmatieh, Shahrekord
City
Shahrekord

2

Recruitment center
Name of recruitment center
Diabetic polyclinic
Full name of responsible person
Mohammad Mirzaei
Street address
Diabetic polyclinic, Chahar bagh bala, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Keyhan Ghatreh
Street address
Vice chancellor for research, Shahrekord University of Medical Science, Rahmatieh, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
1393-01-87-2199
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shahrekord University of Medical Science
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
Shahrekord University of Medical Science
Full name of responsible person
Mohammad Hosein Gharib
Position
Msc student
Other areas of specialty/work
Street address
Shahrekord University of Medical Science, Rahmatieh, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 0061
Fax
Email
mohogharib@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Science
Full name of responsible person
keyhan Ghatreh
Position
Doctor of Biochchemistry
Other areas of specialty/work
Street address
Shahrekord University of Medical Science, Rahmatieh, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 0062
Fax
Email
ghatreh_k@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Science
Full name of responsible person
Mohammad Hosein Gharib
Position
Msc student
Other areas of specialty/work
Street address
Shahrekord University of Medical Science, Rahmatieh, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 0061
Fax
Email
mohogharib@skums.ac.ir
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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