Double blinded Clinical trial of comparison between the effect of ginger and placebo on blood glucose in the women with gestational diabetes in two groups of ginger and placebo
Purpose of this 3rd phase research is investigating the effect of ginger tablets on the blood sugar of women with gestational diabetes whom they are in 24-28 weeks of pregnancy and are referred to Arash hospital. For these 80 pregnant women with gestational diabetes that are screened by glucose tolerance test will choose and divide into two groups and randomized through blocking. We will give ginger tablets in 3 tablets with dose 1500 milligrams to women in case group and placebo tablets to control group with same dose. Between two groups the blood sugar levels will test by using glucose tolerance test values and homeostasis model assessment index before and 6 weeks after the intervention. In addition non of researchers and research instances do not know any of groups uses the ginger tablets or placebos.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090523897N1
Registration date:2016-05-10, 1395/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-10, 1395/02/21
Registrant information
Name
ِDr. Shahideh Jahanian Sadatmahalleh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4826
Email address
shahideh.jahanian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2016-01-10, 1394/10/20
Expected recruitment end date
2016-05-10, 1395/02/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blinded Clinical trial of comparison between the effect of ginger and placebo on blood glucose in the women with gestational diabetes in two groups of ginger and placebo
Public title
Ginger Tablets effect on gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with one fetus in uterine;
The women who their Fasting Blood Sugars are below of 92 in their first visit of prenatal care;
The women with gestational diabetes diagnosis in 24-28 weeks of pregnancy;
Lack of using drugs that affects blood sugar;
Lack of having underlying disease such as cardiovascular, respiratory or renal diseases;
The women who had normal Blood Sugar before pregnancy;
Lack of hard exercise;
Lack of need to insulin therapy by doctor diagnose;
Women who candidate for low sugar diet treatment;
exclusion criteria:
any reaction of body and sensitivity to tablets
Age
From 18 years old to 50 years old
Gender
Female
Phase
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
Single
Other design features
Randomization:
In this research randomization is done through 3 and 6 blocks and through this blocks persons go to drug group or placebo group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr bridg, Ale ahmad high way,Tehran
City
Tehran
Postal code
14115-331
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.TMU.REC.1394.181
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Blood glucose
Timepoint
Before intervention, Six weeks after intervention
Method of measurement
Glucose Tolerance Test. Iin this test fast blood sugar of persons will measure and then 1 hour and 2 hours after using 75 gr glucose blood sugar of them will measure.
2
Description
Resistance to insulin index
Timepoint
Before intervention, Six weeks after intervention
Method of measurement
Through measure of fast blood sugar and fasting insulin with formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will take ginger tablets which made by dineh company and contain 500 milligram of ginger, they will use 1500 milligram daily for 6 weeks.
Category
Treatment - Drugs
2
Description
Control groups take placebo tablets
in dose 500 milligrams which are made by Dineh company and use 1500 milligrams of these placebos daily for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Shahide Jahanian
Street address
Arash hospital, third Sq. of Tehranpars, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tarbiat Modares University
Full name of responsible person
Mansoure Movahedin
Street address
Faculty of Medical Sience 1 , Tarbiat Modares University , Nasr bridge, Jalal Al Ahmad Highway,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Shahideh Jahanian
Position
Assistant professor
Other areas of specialty/work
Street address
Tarbiat Modares University , Nasr bridge،Jalal Al Ahmad High way, Tehran
City
Tehran
Postal code
Phone
+98 21 8801 3030
Fax
Email
shahideh.jahanian@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shahideh Jahanian
Position
Assistant professor
Other areas of specialty/work
Street address
Tarbiat Modares University، Jalal Al Ahmad High way, Tehran
City
Tehran
Postal code
Phone
+98 21 8801 3030
Fax
Email
shahideh.jahanian@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)