Coagulation Disorder
Conditions
Keywords
Coagulation, Chamomile
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTChamomile Tea
Chamomile tea bags consumed by subjects as described in study arms section.
DIETARY_SUPPLEMENTChamomile Extract Capsule
Chamomile extract capsules consumed by subjects as described in Experimental: Chamomile Extract Capsule study arms section.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Prothrombin Time | At two hours and four hours after the intervention |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed