Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder
• Intervention / Treatment: Dietary supplement: Chamomile Tea; Dietary supplement: Chamomile Extract Capsule; Dietary supplement: Placebo Capsule

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Capsule	Dietary supplement: Placebo Capsule; Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section.
Experimental: 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.	Dietary supplement: Chamomile Tea; Chamomile tea bags consumed by subjects as described in study arms section.
Experimental: 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.	Dietary supplement: Chamomile Extract Capsule; Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Prothrombin Time	One week following each treatment

Secondary Outcome Measures

Outcome Measure	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	One week following each treatment

Collaborators and Investigators

• Sponsor: Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Coagulation; Chamomile
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: IRB2021-00314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No