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The Acute Effects 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
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 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

Sites / Locations

  • Stony Brook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chamomile Tea

Chamomile Extract Capsule

Arm 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.

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.

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
February 27, 2022
Last Updated
June 8, 2022
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT05272475
Brief Title
The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
Official Title
The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 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 complete crossover study will investigate the impact of chamomile ingestion acutely on coagulation.
Detailed 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.

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
Our study is a crossover trial with subjects randomized to one of two treatment sequences: (A) a single dose of chamomile extract capsule followed by a single dose of chamomile tea or (B) a single dose of chamomile tea followed by a single dose of chamomile extract capsule. The study requires two visit days where subjects will consume their assigned chamomile preparation at the research site. To minimize any carryover effects, the two visits must be at least 3 days apart, and no more than 8 weeks apart. Randomization will be computer-generated by the biostatistician using the SAS software, and implemented using REDCap software
Masking
Investigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chamomile Tea
Arm Type
Experimental
Arm 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.
Arm Title
Chamomile Extract Capsule
Arm Type
Experimental
Arm 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.
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.
Primary Outcome Measure Information:
Title
Change in Prothrombin Time
Time Frame
At two hours and four hours after the intervention
Secondary Outcome Measure Information:
Title
Change in Activated Partial Thromboplastin Time
Time Frame
At two hours and four hours after the intervention
Title
Change in Thrombin Time
Time Frame
At two hours and four hours after the intervention
Title
Change in Reptilase Time
Time Frame
At two hours and four hours after the intervention

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

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