Role of Ginkgo Biloba Extract in IUGR

Intrauterine Growth Restriction (IUGR) Clinical Trial

Official title:

Effects of Oral Ginkgo Biloba Extract on Pregnancy Complicated by Asymmetrically Intrauterine Growth Restriction: a Double-blinded Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425436
• Other study ID #: Tibonina/ IUGR
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2015
• Last updated: March 20, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt:Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction (IUGR)

Intervention

Drug:
• Ginkgo Biloba Extract

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal weight (gm)		one and half year	Yes
Secondary	Doppler blood flow changes in uterine arteries indices		one and half year	Yes
Secondary	Doppler blood flow changes in umbilical arteries indices		one and half year	Yes
Secondary	Doppler blood flow changes in middle cerebral artery indices		one and half year	Yes