Role of Ginkgo Biloba Extract in IUGR
Primary Purpose
Intrauterine Growth Restriction (IUGR)
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ginkgo Biloba Extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intrauterine Growth Restriction (IUGR)
Eligibility Criteria
Inclusion Criteria:
- Pregnant women in their third trimester (28-30 weeks of gestation).
- Pregnant women whose pregnancy was complicated with intra uterine growth restriction (IUGR).
- Normal Doppler indices in uterine, umbilical and middle cerebral arteries at time of recruitment.
Exclusion Criteria:
- Multiple pregnancies,
- Hypertension,
- Fetal congenital anomalies,
- Previous history of congenital anomalies or chromosomal abnormalities.
- Diabetes Mellitus
- Premature pre-labor rupture of membranes
- Antepartum hemorrhage
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ginkgo Biloba Extract group
Placebo group
Arm Description
This group received Ginko Biloba, two tablets per day
This group received placebo two tablets per day .
Outcomes
Primary Outcome Measures
Fetal weight (gm)
Secondary Outcome Measures
Doppler blood flow changes in uterine arteries indices
Doppler blood flow changes in umbilical arteries indices
Doppler blood flow changes in middle cerebral artery indices
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02425436
Brief Title
Role of Ginkgo Biloba Extract in IUGR
Official Title
Effects of Oral Ginkgo Biloba Extract on Pregnancy Complicated by Asymmetrically Intrauterine Growth Restriction: a Double-blinded Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The use of herbal medicinal products is increasing enormously in recent years, mainly among women, who use them for the most varied purposes, such as in menstrual problems, menopausal symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral, antioxidant and antiinflammatory activities, as well as being used in the treatment of osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from the consumption of flavonoids, little is known about their safety and potentially harmful toxic effects, such as mutagenicity and genotoxicity which might occur if taken in large doses . Safety of Ginkgo biloba during pregnancy or lactation was not criticized in literature. Roasted and raw ginkgo seed were not reported in the evidence-based medicine literature as being either safe or contraindicated in pregnancy or lactation. A higher incidence of postpartum hemorrhage was reported in the literature when associated with a 3-month ingestion of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L. (Ginkgoaceae), a medicinal plant widely used by the population . G. biloba has its origin in China, Korea and Japan where its fruits and leaves have been used as food and medicine for a long time.
The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e., ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose metabolites were found in the blood of rats and in human urine after oral administration of EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used in the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular insufficiency and peripheral arterial occlusive disease . In folk medicine, EGb is used as a vermifuge, to induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis and edema . The aim of this study was to evaluate the effect of oral supplementation of Ginkgo Biloba extract on the fetal weight as well as feto-maternal blood flow in cases of intrauterine growth restriction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction (IUGR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ginkgo Biloba Extract group
Arm Type
Active Comparator
Arm Description
This group received Ginko Biloba, two tablets per day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group received placebo two tablets per day .
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba Extract
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Fetal weight (gm)
Time Frame
one and half year
Secondary Outcome Measure Information:
Title
Doppler blood flow changes in uterine arteries indices
Time Frame
one and half year
Title
Doppler blood flow changes in umbilical arteries indices
Time Frame
one and half year
Title
Doppler blood flow changes in middle cerebral artery indices
Time Frame
one and half year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women in their third trimester (28-30 weeks of gestation).
Pregnant women whose pregnancy was complicated with intra uterine growth restriction (IUGR).
Normal Doppler indices in uterine, umbilical and middle cerebral arteries at time of recruitment.
Exclusion Criteria:
Multiple pregnancies,
Hypertension,
Fetal congenital anomalies,
Previous history of congenital anomalies or chromosomal abnormalities.
Diabetes Mellitus
Premature pre-labor rupture of membranes
Antepartum hemorrhage
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Role of Ginkgo Biloba Extract in IUGR
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