Role of Ginkgo Biloba Extract in IUGR

NCT ID: NCT02425436

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Intrauterine Growth Restriction (IUGR)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ginkgo Biloba Extract group

This group received Ginko Biloba, two tablets per day

Group Type: ACTIVE_COMPARATOR

Ginkgo Biloba Extract

Intervention Type: DRUG

Placebo group

This group received placebo two tablets per day .

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Ginkgo Biloba Extract

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

mohamad sayed abdellah

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Tibonina/ IUGR

Identifier Type: -

Identifier Source: org_study_id