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

Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05272475
• Other study ID #: IRB2022-00036
• Status: Completed
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: May 12, 2022

Study information

• Verified date: June 2022
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders

Intervention

Dietary Supplement:
• Chamomile Tea
Chamomile tea bags consumed by subjects as described in study arms section.
• Chamomile Extract Capsule
Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Prothrombin Time		At two hours and four hours after the intervention
Secondary	Change in Activated Partial Thromboplastin Time		At two hours and four hours after the intervention
Secondary	Change in Thrombin Time		At two hours and four hours after the intervention
Secondary	Change in Reptilase Time		At two hours and four hours after the intervention