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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02442492 -
Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction
|
Phase 2/Phase 3 |