The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

Conditions
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Coagulation Disorder

Intervention / Treatment
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* Dietary Supplement: Chamomile Tea
* Dietary Supplement: Chamomile Extract Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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: Ginger Garlic Gingko Ginseng Fish oil Black Cohosh Feverfew Valerian 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Our study is a crossover trial with subjects randomized to one of two treatment sequences: (A) a single dose of chamomile extract capsule followed by a single dose of chamomile tea or (B) a single dose of chamomile tea followed by a single dose of chamomile extract capsule. The study requires two visit days where subjects will consume their assigned chamomile preparation at the research site. To minimize any carryover effects, the two visits must be at least 3 days apart, and no more than 8 weeks apart. Randomization will be computer-generated by the biostatistician using the SAS software, and implemented using REDCap software
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chamomile Tea<br>Subjects will consume a single serving of chamomile tea on the visit day. The tea serving will be prepared using 3 grams of chamomile tea steeped in hot water according to the study protocol. | Dietary Supplement: Chamomile Tea<br>* Chamomile tea bags consumed by subjects as described in study arms section.<br>|
| Experimental: Chamomile Extract Capsule<br>Subjects will consume a single chamomile capsule on the visit day. Each capsule consists of 500 milligrams of a chamomile extract that has been standardized to 1.2% apigenin content. | Dietary Supplement: Chamomile Extract Capsule<br>* Chamomile extract capsules consumed by subjects as described in Experimental: Chamomile Extract Capsule study arms section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prothrombin Time |  | At two hours and four hours after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Activated Partial Thromboplastin Time |  | At two hours and four hours after the intervention | 
| Change in Thrombin Time |  | At two hours and four hours after the intervention | 
| Change in Reptilase Time |  | At two hours and four hours after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coagulation, Chamomile