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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Capsule | Placebo Comparator |
| |
| Chamomile Tea | Experimental | 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. |
|
| Chamomile Extract Capsule | Experimental | 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. |
|
| 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 | One week following each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activated Partial Thromboplastin Time | One week following each treatment | |
| Change in Thrombin Time | One week following each treatment | |
| Change in Reptilase Time |
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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 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:
Baseline CBC with either a hematocrit below 30% or platelet count below 150,000, white blood cell count above 15,000 or less than 3,000.
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
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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 |
|---|---|---|---|
| 37730613 | Derived | Schwartz JA, Romeiser JL, Kimura R, Senzel L, Galanakis D, Halper D, Mena S, Bennett-Guerrero E. Effect of chamomile intake on blood coagulation tests in healthy volunteers: a randomized, placebo-controlled, crossover trial. Perioper Med (Lond). 2023 Sep 20;12(1):51. doi: 10.1186/s13741-023-00339-7. |
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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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This is a placebo-controlled complete crossover study with 3 treatments: (A) placebo, (B) chamomile extract capsule, and (C) chamomile tea. Every participant will receive all three treatments. There are 6 possible sequences of treatment (ABC, ACB, BAC, BCA, CAB, CBA). Blocked randomization lists for sequence assignment will be computed using statistical software. Each participant will be randomly assigned one of the six treatment sequences using REDCap software. Carryover effects will be minimized by maintaining a consistent washout time of 1 week between treatments. Blood sampling will be conducted immediately before and after the treatment weeks.
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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. |
|
| Placebo Capsule | Dietary Supplement | Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section. |
|
| One week following each treatment |
| D006425 |
| Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |