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Role of Ginkgo Biloba Extract in IUGR

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02425436
First Posted: April 24, 2015
Last Update Posted: March 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
mohamad sayed abdellah, Assiut University
  Purpose

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.


Condition Intervention Phase
Intrauterine Growth Restriction (IUGR) Drug: Ginkgo Biloba Extract Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral Ginkgo Biloba Extract on Pregnancy Complicated by Asymmetrically Intrauterine Growth Restriction: a Double-blinded Randomized Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by mohamad sayed abdellah, Assiut University:

Primary Outcome Measures:
  • Fetal weight (gm) [ Time Frame: one and half year ]

Secondary Outcome Measures:
  • Doppler blood flow changes in uterine arteries indices [ Time Frame: one and half year ]
  • Doppler blood flow changes in umbilical arteries indices [ Time Frame: one and half year ]
  • Doppler blood flow changes in middle cerebral artery indices [ Time Frame: one and half year ]

Enrollment: 226
Study Start Date: May 2014
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ginkgo Biloba Extract group
This group received Ginko Biloba, two tablets per day
Drug: Ginkgo Biloba Extract
Placebo Comparator: Placebo group
This group received placebo two tablets per day .
Other: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: mohamad sayed abdellah, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02425436     History of Changes
Other Study ID Numbers: Tibonina/ IUGR
First Submitted: April 21, 2015
First Posted: April 24, 2015
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes