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临床试验/NCT02425436
NCT02425436已完成2 期

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

Assiut University0 个研究点目标入组 226 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
226
主要终点
Fetal weight (gm)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Multiple pregnancies,
  • Hypertension,
  • Fetal congenital anomalies,
  • Previous history of congenital anomalies or chromosomal abnormalities.
  • Diabetes Mellitus
  • Premature pre-labor rupture of membranes
  • Antepartum hemorrhage

研究组 & 干预措施

Ginkgo Biloba Extract group

Active Comparator

This group received Ginko Biloba, two tablets per day

干预措施: Ginkgo Biloba Extract (Drug)

Placebo group

Placebo Comparator

This group received placebo two tablets per day .

干预措施: Placebo (Other)

结局指标

主要结局

Fetal weight (gm)

时间窗: one and half year

次要结局

  • Doppler blood flow changes in middle cerebral artery indices(one and half year)
  • Doppler blood flow changes in uterine arteries indices(one and half year)
  • Doppler blood flow changes in umbilical arteries indices(one and half year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mohamad sayed abdellah

Dr

Assiut University

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