The aim of this study is prevention of preeclampsia, that threatening the life of mother and fetus. This intervention study will be performed as a Double-Blind Randomized Clinical Trial among human subjects. Primigravid Pregnant women in third trimester will be randomly assigned to receive either garlic capsule or placebo capsules (each group 28 subjects). The study outcome, including preeclampsia and drug adverse effects, would be compared across the groups. Physician and Pregnant women are blind about the prescribed capsule. Inclusion criteria are first pregnancy, Turkmen ethnicity, being high-risk for preeclampsia (those with self/family history of preeclampsia), presence of chronic hypertension, lack of hypersensitivity to garlic, and signing the informed consent form. For resolving the problem of cases lost to follow-up, 10% higher than calculated sample population would be enrolled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015053122490N1
Registration date:2015-09-04, 1394/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Shohreh Vosoogh
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 1910
Email address
dr.vosoogh@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Pharmaceutical Sciences
Expected recruitment start date
2015-02-19, 1393/11/30
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Garlic capsule efficacy for reduction of preeclampsia risk among high-risk pregnant Turkmen women
Public title
the Effects of Garlic capsules in prevention of preeclampsia in pregnant Turkmen women
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:
first pregnancy, Turkmen ethnicity, being those with self or family history of preeclampsia, presence of chronic hypertension, and signing the informed consent form
exclusion criteria:
hypersensitivity to garlic, Lack of consent to participate in the study
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:
28
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
Ethics Committee Islamic Azad University, Pharmaceutical Sciences Branch
Street address
No 99, Yasaman Street, Shariati Street
City
Tehran
Postal code
Approval date
2014-12-16, 1393/09/25
Ethics committee reference number
13372
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
o10.0, o14
ICD-10 code description
Pre-existing essential hypertension complicating pregnancy, childbirth and the puerperium, moderate pre-eclampsia, severe pre-eclampsia
Primary outcomes
1
Description
blood pressure
Timepoint
at 28 week, at 32 week, at 36 week
Method of measurement
The use of mercury blood pressure device
Secondary outcomes
empty
Intervention groups
1
Description
therapeutic intervention with drug( garlic capsule)
,with dose of 800mg, once a day, for 2 month (from the 28th up to 36th week of pregnancy period)
Category
Treatment - Drugs
2
Description
therapeutic intervention with placebo, pharmaceutical starch with dose of 800mg, once a day, for 2 month(from the 28th up to 36th week of pregnancy period)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers In Golestan Province
Full name of responsible person
Shohreh Vosoogh
Street address
Sayad Shirazi Hospital, Sayad Shirazi Street
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Sepideh Arbabi Bid Goli
Street address
No99, Yasaman Street, Shariati Street
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 Islamic Azad University, Pharmaceutical Sciences Branch
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
Golestan University of Medical Sciences
Full name of responsible person
Shohreh Vosoogh
Position
Fellowship Perinatology/Assistant Professor
Other areas of specialty/work
Street address
Sayad Shirazi Hospital, Sayad Shirazi Street
City
Gorgan
Postal code
Phone
+98 17 3226 1175
Fax
Email
dr.vosoogh@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Shohreh Vosoogh
Position
Fellowship Perinatology
Other areas of specialty/work
Street address
Sayad Shirazi Street, Sayad Shirazi Hospital
City
Gorgan
Postal code
Phone
+98 17 3226 1175
Fax
+98 32261175
Email
dr.vosoogh@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Shima Afshar
Position
Doctor of Pharmacy
Other areas of specialty/work
Street address
No99, Yasaman Street. Shariati Street
City
Tehran
Postal code
Phone
+98 21 8802 9845
Fax
Email
afshar.shiima@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)