CClinicalTrials.gg
CompletedNCT05272475Updated Jun 10, 2022

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

An interventional study of Chamomile Tea and Chamomile Extract Capsule in Coagulation Disorder, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-10.

Sponsored by Stony Brook University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coagulation Disorder

Keywords

  • Coagulation
  • Chamomile
03

In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's enrollment of 8 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Chamomile Tea

    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.

    Dietary Supplement: Chamomile Tea

  • Experimental
    Chamomile Extract Capsule

    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.

    Dietary Supplement: Chamomile Extract Capsule

Interventions

  • Dietary supplementChamomile Tea

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

  • Dietary supplementChamomile Extract Capsule

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

06

What researchers measure

Primary outcomes

  1. Change in Prothrombin Time

    Time frame: At two hours and four hours after the intervention

Secondary outcomes

  1. Change in Activated Partial Thromboplastin Time

    Time frame: At two hours and four hours after the intervention

  2. Change in Thrombin Time

    Time frame: At two hours and four hours after the intervention

  3. Change in Reptilase Time

    Time frame: At two hours and four hours after the intervention

07

Study locations

1 site
  • Stony Brook University Hospital
    Stony Brook, New York 11794, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05272475
Lead sponsor
Stony Brook University
Responsible party
Jonathon Schwartz (Clinical Assistant Professor, Stony Brook University) — Principal investigator
First posted
Mar 9, 2022
Start date
Mar 16, 2022
Primary completion
May 12, 2022
Completion
May 12, 2022
Last update
Jun 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion