Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

Not Applicable

Completed

• Conditions: Coagulation Disorder
• Interventions: Dietary Supplement: Placebo Capsule; Dietary Supplement: Chamomile Tea; Dietary Supplement: Chamomile Extract Capsule

• Registration Number: NCT05006378
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-08
• Study First Posted: 2021-08-16
• Study Start: 2021-08-31
• Primary Completion: 2022-01-19
• Study Completion: 2022-01-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Capsule	Placebo Capsule	-
Chamomile Tea	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.
Chamomile Extract Capsule	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.

Primary Outcome Measures

Name	Time	Method
Change in Prothrombin Time	One week following each treatment

Secondary Outcome Measures

Name	Time	Method
Change in Activated Partial Thromboplastin Time	One week following each treatment
Change in Thrombin Time	One week following each treatment
Change in Reptilase Time	One week following each treatment

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States