The effect of aqueous extract Thymus kotschyanus Boiss. et Hohen. on glycemic control and dyslipidemia associated with type II diabetes is determined.
Inclusion Criteria: no hypertension; no myocardial infarction; not taking Insulin.
Exclusion Criteria: Not wanting to continue cooperation.
64 patients aged 30-60 years with confirmed diagnosis of type II diabetes selected from Diabetes Center of Arak. The intervention group has taken drugs as usual plus Thymus. K aqueous 20 grams per day. The control group has taken drugs only. Before and three months after intervention, blood glucose and lipid profile measured based on the same methodology in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080129149N1
Registration date:2016-09-09, 1395/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-09, 1395/06/19
Registrant information
Name
Saeed Changizi-Ashtiyani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3545
Email address
dr.ashtiyani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Arak University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-02-09, 1394/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Thymus kotschyanus Boiss. et Hohen. on glycemic control and dyslipidemia of patients with type II diabetes
Public title
The effect of aqueous extract Thymus kotschyanus Boiss. et Hohen. on glycemic control and dyslipidemia associated with type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: no hypertension; no myocardial infarction; not taking Insulin.
Exclusion Criteria: Not wanting to continue cooperation.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Sardasht Sq.
City
Arak
Postal code
Approval date
2014-04-27, 1393/02/07
Ethics committee reference number
92-160-6
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus Type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting Blood sugar
Timepoint
Before and after intervention
Method of measurement
Test of Blood sample in laboratory
Secondary outcomes
1
Description
Blood Lipids
Timepoint
Before and After intervention
Method of measurement
Test of Blood sample in Laboratory
Intervention groups
1
Description
]ntervention group: The intervention group has taken drugs as usual plus Thymus. K aqueous 20 grams per day.
Category
Treatment - Other
2
Description
Control group: The control group has taken drugs only.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Arak
Full name of responsible person
Dr. Saied Changizi-Ashtiyani
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saied Changizi-Ashtiyani
Street address
Sardasht Sq.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Saied Changizi-Ashtiyani
Position
Faculty Member
Other areas of specialty/work
Street address
Sadasht Sq.
City
Arak
Postal code
Phone
+86 34173545
Fax
Email
dr.ashtiyani@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saied Changizi-Ashtiyani
Position
Faculty Member
Other areas of specialty/work
Street address
Sardash Sq.
City
Arak
Postal code
Phone
+98 86 3417 3545
Fax
Email
dr.ashtiyani@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Saied Changizi-Ashtiyani
Position
Faculty Member
Other areas of specialty/work
Street address
Sardasht Sq.
City
Arak
Postal code
Phone
+86 34173505
Fax
Email
dr.ashtiyani@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)