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

Stony Brook University

Status: Completed

Conditions: Coagulation Disorder

Treatments: Dietary Supplement: Chamomile Extract Capsule; Dietary Supplement: Chamomile Tea

Study type: Interventional

Funder types: Other

Identifiers

NCT05272475

IRB2022-00036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Chamomile Tea

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Chamomile Tea

Chamomile Extract Capsule

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Chamomile Extract Capsule