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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Growth Restriction (IUGR)

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    April 21, 2015
    Last Updated
    March 20, 2016
    Sponsor
    Assiut University
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    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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