Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 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, placebo-controlled complete crossover study will investigate the impact of chamomile ingestion on coagulation.
详细描述
Subjects will be enrolled into three groups in a crossover fashion upon obtaining written informed consent. Baseline laboratory screening assays of anticoagulation will be obtained. The three intervention groups include (1) chamomile tea intake, (2) chamomile extract intake and (3) placebo capsules. Subjects will consume the chamomile or placebo preparations for one week and partake in a one-week washout period between interventions. Screening assays of coagulation will be obtained immediately before and after each intervention week.
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
- Double (Participant, 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.
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 screening
- •Females who are pregnant, breast-feeding, or lactating
- •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 (including baseline study) 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
- •Baseline CBC with either a hematocrit below 30% or platelet count below 150,000, white blood cell count above 15,000 or less than 3,
- •Inability to discontinue the aforementioned herbal supplements more than 14 days before enrollment into the study.
- •History of estrogen-dependent condition such as uterine fibroids, breast cancer, uterine cancer, or ovarian cancer
- •Significant fear of needles or fainting blood draws
- •Actively taking cyclosporine
- •Patient refusal to participate in study for the allotted study period
研究组 & 干预措施
Placebo Capsule
干预措施: Placebo Capsule (Dietary Supplement)
Chamomile Extract Capsule
Subjects will consume three chamomile capsules throughout the day for the one-week treatment period. Each capsule consists of 500 milligrams of a chamomile extract that has been standardized to 1.2% apigenin content.
干预措施: Chamomile Extract Capsule (Dietary Supplement)
Chamomile Tea
Subjects will consume three servings of chamomile tea throughout the day for the one-week treatment period. Each tea serving will be prepared using 3 grams of chamomile tea steeped in hot water according to the study protocol.
干预措施: Chamomile Tea (Dietary Supplement)
结局指标
主要结局
Change in Prothrombin Time
时间窗: One week following each treatment
次要结局
- Change in Activated Partial Thromboplastin Time(One week following each treatment)
- Change in Thrombin Time(One week following each treatment)
- Change in Reptilase Time(One week following each treatment)
研究者
Jonathon Schwartz
Clinical Assistant Professor
Stony Brook University