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临床试验/NCT02882776
NCT02882776已完成不适用

The Effect of Daily Ginger Drinking on Platelet's Function in the Saudi Population

King Abdullah International Medical Research Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
The effect of ginger beverage consumption on platelets activity will be examined in apparently healthy, Saudi adult volunteers.

研究概览

简要总结

This study aims to examine the effect of ginger beverage consumption on platelets activity in apparently healthy Saudi adult volunteers.

As for the Saudi population, consumption of powdered ginger dissolved in hot water is a common practice. Accordingly, in this study, it is tempting to speculate the effect of this form of ginger consumption, given in separate time points per day, on platelet aggregation profile by using platelet aggregation analogues. If positive results were obtained, the herb could provide natural protection against the development of platelet aggregation complications and could be a potential alternative to aspirin, used for improving blood circulation and hematological pathophysiologies in diseased individuals.

详细描述

Herbal medicine products are dietary supplements that people take to improve their health. Many herbs have been used for a long time for claimed health benefits. They are sold as tablets, capsules, powders, beverages, extracts and fresh or dried plants. Herbal medicines have been associated with treatment of several physiological disorders of which hematological, mainly clotting disorders. Those include garlic, onion, and ginger in addition to pharmacological reagents such as aspirin, warfarin, heparin, and others. One of the herbal medications affecting hematological profile is ginger which has gained focus throughout studies conducted in previous years in the field of inhibiting platelet aggregation, taking benefit from some undesirable side effects arising from the use of other anti-platelet aggregation agents, especially aspirin.

Ginger (Zingiber officinale) is a well known spice and flavoring agent used in traditional medicine in many countries. It is a source of valuable phytonutrients characterized by having aromatic odor and pungent taste. The ginger rhizome contains 60% starch, 10%proteins, 10% fats, 5% fibers, 6% inorganic material, 10% residual moisture, 1-4% essential oils including gingerol and zingiberene, in addition to pungent principles such as zingerone, gingerol and shogaol. Shogaols are produced by heating gingerols. It has been speculated that ginger can eliminate symptoms associated with a variety of illnesses since there are a variety of chemical classes that these compounds belong to. Ginger has been used in the management of headache, nervous diseases, nausea, and vomiting. It has also been used to treat migraine headaches without side-effects. In addition, it is recommended in the management of rheumatic disorders and muscular pain. Ginger also acts as a metabolic enhancer where acetone extracts of ginger have stimulated bile secretion and excretion of gallstones. Although ginger is considered a safe herbal medicine with only few and insignificant adverse side effects, few undesirable effects like heartburn were noticed. In quantities higher than 6 g ginger may act as a gastric irritant and inhalation of dust from ginger may produce immunoglobulin E (IGE)-mediated allergy.

As for ginger toxicity, an acute overdose of ginger is usually in excess of about 2g of ginger per kilogram of body mass depending on the ginger tolerance level and can result in a state of central nervous system over-stimulation called "ginger gitters".

Experimental data reveals that ginger may be a dual inhibitor of eicosanoid synthesis, inhibiting the synthesis of both prostaglandins and leukotrienes, which are inflammatory mediators produced from arachidonic acid. With reference to the fact that normal platelet functioning is linked to an interplay between those substances, ginger consumption appears to be linked with reducing platelet aggregation.

Platelets have traditionally been linked with concepts of hemostasis and hemorrhagic disorders. However, with increasing incidence of atherosclerosis and hematologic disorders, the critical role played by platelets is more evident. Platelets are no longer viewed as "scaffolding" for the events of the coagulation cascade but rather as important catalysts in hemostasis, thrombosis, and fibrinolysis. Improved understanding of platelet physiology has led to developments of pharmacologic adjuncts resulting in improved patency rates and improved patient outcomes. Platelets are the smallest components in the blood stream, where they exist as a-nucleate disc-shaped cells in their resting state and travel singly as discoidal particles. In the presence of stimuli such as arachidonic acid, activated platelets change shape into spiny spheres. They bind to fibrinogen, aggregate and release the contents of their intracellular granules, including adenosine diphosphate (ADP) and serotonin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Apparently healthy Saudi volunteers of either sex
  • •Age group = 18-60 years.

排除标准

  • •History of organ abnormalities or concomitant illnesses.
  • •Abnormal platelets count or function.
  • •Individuals with bleeding disorder as Von Willebrand Disorder or Hemophilia.
  • •Known allergy to ginger.
  • •Concurrent warfarin ingestion.
  • •History of ingestion of asprin,clopidogrel, nifedipine, non-steroid anti-inflammatory drugs (NSAIDs) or ethanol within the past two week.
  • •Any volunteer ingests ethanol, aspirin, clopidogrel, wine, beer and contraceptive pills during the study duration will be excluded from the study.
  • •pregnant & lactating women.
  • •Individuals on herbal treatment.
  • •Active G.I ulcers/ recently diagnosed G.I ulcers within one month

研究组 & 干预措施

Ginger drink once daily

Other

this group will receive ginger drink made by dissolving 4g ginger powder in plain water once a day for continuous 5 days.

干预措施: Ginger drink (Dietary Supplement)

Ginger drink twice daily

Other

this group will receive ginger drink made by dissolving 4g ginger powder in plain water twice a day for continuous 5 days.

干预措施: Ginger drink (Dietary Supplement)

结局指标

主要结局

The effect of ginger beverage consumption on platelets activity will be examined in apparently healthy, Saudi adult volunteers.

时间窗: 1 year

次要结局

  • The demographic characteristics of the sample under study will be identified.(1 year)
  • Platelets' count before and after ginger consumption will be compared.(1 year)
  • Any change in platelet morphology before and after ginger consumption will be studied(1 year)
  • Any change in platelets function after ginger consumption via addition of aggregation analogues will be studied.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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