NCT05272475已完成不适用
The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Prothrombin Time
研究概览
简要总结
Chamomile may possess anticoagulant effects based on the presence of coumarin-like compounds within the flower. This randomized complete crossover study will investigate the impact of chamomile ingestion acutely on coagulation.
详细描述
Subjects will be enrolled into two groups in a crossover fashion upon obtaining written informed consent. The two intervention groups include (1) chamomile tea intake and (2) chamomile extract intake. Subjects will consume a single preparation of chamomile tea or extract capsule, and partake in a minimum of three days washout period between interventions. Screening assays of coagulation will be obtained immediately before the ingestion of chamomile, two hours after ingestion, and four hours after ingestion over the course of a single day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed written consent
- •Able to withhold use of other chamomile products (teas, lotions, supplements, extracts); will only use study-supplied chamomile products for duration of study
- •Able to withhold intake of solid food at least 6 hours before intake of the chamomile preparation
- •Able to withhold intake of clear liquids at least 2 hours before intake of the chamomile preparation
排除标准
- •Past medical/family history of bleeding/thrombotic disorders (e.g. hemophilia, von-Willebrand disease)
- •Chronic medications known to affect hemostasis (anticoagulants, antiplatelet agents, SSRIs, herbal/complementary medicine agents)
- •Three or more alcoholic drinks daily
- •Sedentary status/ restricted mobility
- •Active smoker or quit smoking within one week of study period
- •Females who are pregnant, breast-feeding, or lactating
- •History of estrogen-dependent condition such as uterine fibroids, breast cancer, uterine cancer, or ovarian cancer
- •Scheduled surgical procedure during study period
- •Hospitalized patients
- •Underweight (BMI < 18 kg/m2) or history of malnourishment
- •Active symptoms of a respiratory, dermatologic, urinary, or gastrointestinal infection
- •Diagnosed allergy to chamomile
- •Severe allergy to ragweed
- •Physical inability to consume chamomile tea according to the study dosing schedule
- •Prescription usage of an anticoagulant agent such as warfarin, anti-Xa inhibitor, or other novel oral anticoagulants
- •ADP antagonist use, including clopidogrel, prasugrel, and ticagrelor
- •GPIIb/IIIa inhibitor use, including ticlopidine, eptifibatide
- •More than weekly NSAID use (e.g. aspirin, ibuprofen, naproxen)
- •Diagnosis of a bleeding-diathesis disorder
- •Diagnosis of a hypercoagulable state
- •History of elevated INR or other abnormal bleeding study (PT, aPTT, thrombin time, reptilase time, above the upper limit of normal for Stony Brook Hospital Reference Range) while not taking anticoagulants or herbal supplements listed below
- •Active intake of the following herbal supplements at time of study enrollment that may alter baseline coagulation function including:
- •Black Cohosh
- •Coenzyme Q10
- •Goldenseal
- •St. John Wort
- •Active intake of chamomile extracts or teas at time of study enrollment
- •Inability to discontinue the aforementioned herbal supplements more than 14 days before enrollment into the study
- •Significant fear of needles or fainting blood draws
- •Actively taking cyclosporine
- •Patient refusal to participate in study for the allotted study period
结局指标
主要结局
Change in Prothrombin Time
时间窗: At two hours and four hours after the intervention
次要结局
- Change in Activated Partial Thromboplastin Time(At two hours and four hours after the intervention)
- Change in Reptilase Time(At two hours and four hours after the intervention)
- Change in Thrombin Time(At two hours and four hours after the intervention)
研究者
Jonathon Schwartz
Clinical Assistant Professor
Stony Brook University
研究点 (2)
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