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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chamomile Tea | Experimental | 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. |
|
| Chamomile Extract Capsule | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chamomile Tea | Dietary Supplement | Chamomile tea bags consumed by subjects as described in study arms section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prothrombin Time | At two hours and four hours after the intervention |
| 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 | |
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Inclusion Criteria:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38300838 | Derived | Kimura R, Schwartz JA, Romeiser JL, Senzel L, Galanakis D, Halper D, Bennett-Guerrero E. The Acute Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers: A Randomized Trial. J Appl Lab Med. 2024 May 2;9(3):468-476. doi: 10.1093/jalm/jfad120. |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000713170 | Chamomile extract |
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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
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| Chamomile Extract Capsule | Dietary Supplement | Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section. |
|
| Change in Reptilase Time |
| At two hours and four hours after the intervention |
| D006425 |
| Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |