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Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

Primary Purpose

Coagulation Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chamomile Tea
Chamomile Extract Capsule
Placebo Capsule
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Coagulation Disorder focused on measuring Coagulation, Chamomile

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

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

Sites / Locations

  • Stony Brook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo Capsule

Chamomile Tea

Chamomile Extract Capsule

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Prothrombin Time

Secondary Outcome Measures

Change in Activated Partial Thromboplastin Time
Change in Thrombin Time
Change in Reptilase Time

Full Information

First Posted
July 27, 2021
Last Updated
February 8, 2022
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT05006378
Brief Title
Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
Official Title
Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
January 19, 2022 (Actual)
Study Completion Date
January 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulation Disorder
Keywords
Coagulation, Chamomile

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Capsule
Arm Type
Placebo Comparator
Arm Title
Chamomile Tea
Arm Type
Experimental
Arm Description
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.
Arm Title
Chamomile Extract Capsule
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chamomile Tea
Intervention Description
Chamomile tea bags consumed by subjects as described in study arms section.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chamomile Extract Capsule
Intervention Description
Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Capsule
Intervention Description
Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section.
Primary Outcome Measure Information:
Title
Change in Prothrombin Time
Time Frame
One week following each treatment
Secondary Outcome Measure Information:
Title
Change in Activated Partial Thromboplastin Time
Time Frame
One week following each treatment
Title
Change in Thrombin Time
Time Frame
One week following each treatment
Title
Change in Reptilase Time
Time Frame
One week following each treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

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