The current study is a randomized, triple-blind, placebo-controlled trial. Research setting will be high risk pregnancy clinics of Taleghany and Alzahra hospitals in Tabriz. This clinical trial will be conducted on 76 pregnant women. Eligible people after obtaining written informed consent qualified subject to a randomized block design with four and six blocks and with allocation ratio of 1:1 would be allocated in two group. 500 mg capsules of ginger and placebo with similar appearance will be prepared by a pharmacist. The placebo capsules in order to scent after preparing, will be placed in the vicinity of ginger powder for two weeks and then will be packaged in similar cans. This drug is administered (daily, every 12 hours one capsule) from 28 weeks of gestation for 8 weeks. The primary outcomes of this study will be Fasting blood sugar control status for women with gestational diabetes and intake dose of insulin , secondary outcomes will be prevalence of preeclampsia, urinary tract infections,Mean of HbA1C, Fetal bio metric criteria, the number of mothers visits by a specialist physician, side events and satisfaction of drug using during the study . After collecting all the information, the data will be analyzed by using descriptive and analytical statistics of SPSS 21 software including ANCOVA and repeated measure ANOVA test; all of the analyzes will be conducted on the basis of Intention to treat analysis.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201604043027N36
Registration date:2016-12-08, 1395/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Ginger Capsule on Blood Sugar Control status in Gestational Diabetes: a Triple Blind Randomized Controlled Trial
Public title
The Effect of Ginger Capsule on Blood Sugar Control Status in Women with Gestational Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having an ultrasound based on singleton pregnancy; Gestational age between 24-28 weeks; Pregnant women aged 18-35 years; Pregnant woman with gestational diabetes who inject insulin and respond to insulin treatment; Normal blood pressure (less than 140/90 mmHg) in the current pregnancy and the absence of proteinuria in pregnancy tests; have at least read and write literacy; Willingness to participate in the study; Having telephone number and address for follow up; Having health records in Taleghani and ALzahra hospitals in Tabriz.
Exclusion criteria: Alcohol or tobacco consumption; The use of traditional medicines, especially cinnamon; Mothers with a history of chronic hypertension; Blood glucose less than 70 mg/dl
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
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 Sciences
Street address
Research Vice-Chancellor, number 2 Central Building, Tabriz University of Medical Sciences, Golgasht ave, Tabriz, Iran
City
Tabriz
Postal code
5165665931
Approval date
2016-05-10, 1395/02/21
Ethics committee reference number
IR.TBZMED.REC.1395.103
Health conditions studied
1
Description of health condition studied
GDM
ICD-10 code
E00-E90
ICD-10 code description
endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Fasting blood sugar before and after of intervention in groups of study
Timepoint
Before intervention 2, 4, 6 and 8 weeks after intervention
Method of measurement
Laboratory and check list
2
Description
Average blood sugar 2 hours after meals before and after intervention in groups of study
Timepoint
Before intervention2,4, 6 and 8 weeks after intervention
Method of measurement
Laboratory and check lists
3
Description
Insulin dose in the study groups
Timepoint
8 weeks after intervention
Method of measurement
check lists
Secondary outcomes
1
Description
Incidence of urinary tract infection in the study groups
Timepoint
8 weeks after intervention
Method of measurement
Laboratory and check list
2
Description
The mean of HbA1C in the study groups
Timepoint
8 weeks after intervention
Method of measurement
Laboratory and check list
3
Description
The fetal biometric criterias (femur length, head circumference, biparietal diameter, abdominal circumference and fetal weight) in the study groups
Timepoint
8 weeks after intervention
Method of measurement
Sonography and check list
4
Description
Incidence of preeclampsia in the study groups
Timepoint
8 weeks after intervention
Method of measurement
The blood pressure according to millimeter of mercury by using a analog sphygmomanometer and random urine albumin by using diagnostic strips for urine protein assay
5
Description
Mothers satisfaction of the received drugs in the study groups
Timepoint
8 weeks after intervention
Method of measurement
The check list of satisfaction of received drug
6
Description
Frequency of side events in the study groups
Timepoint
8 weeks after intervention
Method of measurement
The side events check list
7
Description
Number of specialist physician visits to control diabetes in study groups
Timepoint
8 weeks after intervention
Method of measurement
check list
Intervention groups
1
Description
Intervention group: Ginger capsule, 500 mg, orally, daily (one capsule every 12 hours) for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo, orally, quite similar to ginger capsule, daily (one capsule every 12 hours) for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani and Alzahra hospitals in Tabriz
Full name of responsible person
Bahramian, Zohre
Street address
Faculty of nursing and midwifery
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mirghafourvand
Street address
Research Vice-Chancellor, number 2 Central Building, Tabriz University of Medical Sciences, Golgasht ave, Tabriz, Iran
City
Tabriz
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
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
Faculty of nursing and midwifery
Full name of responsible person
Shafaie sehhatie fahimeh
Position
Master of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Shariati ave, Tabriz, Iran
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
fahimehsehhatie@yahoo.com
Web page address
sehhatief@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing and midwifery
Full name of responsible person
Shafaie sehhatie fahimeh
Position
Master of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Shariati ave, Tabriz, Iran
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
fahimehsehhatie@yahoo.com
Web page address
sehhatief@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of nursing and midwifery
Full name of responsible person
Shafaie sehhatie fahimeh
Position
Master of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Shariati ave, Tabriz, Iran
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
fahimehsehhatie@yahoo.com
Web page address
sehhatief@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)