Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

NCT ID: NCT05006378

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-01-19

Brief Summary

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.

Detailed Description

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.

Conditions

Coagulation Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Placebo Capsule

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section.

Chamomile Tea

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.

Group Type: EXPERIMENTAL

Chamomile Tea

Intervention Type: DIETARY_SUPPLEMENT

Chamomile tea bags consumed by subjects as described in study arms section.

Chamomile Extract Capsule

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.

Group Type: EXPERIMENTAL

Chamomile Extract Capsule

Intervention Type: DIETARY_SUPPLEMENT

Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.

Interventions

Chamomile Tea

Chamomile tea bags consumed by subjects as described in study arms section.

Intervention Type: DIETARY_SUPPLEMENT

Chamomile Extract Capsule

Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Capsule

Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

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:

• Ginger
• Garlic
• Gingko
• Ginseng
• Fish oil
• Black Cohosh
• Feverfew
• Valerian
• Coenzyme Q10
• Goldenseal
• St. John Wort
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Jonathon Schwartz

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37730613 (View on PubMed)

Other Identifiers

IRB2021-00314

Identifier Type: -

Identifier Source: org_study_id