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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05006378
Other study ID # IRB2021-00314
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2021
Est. completion date January 19, 2022

Study information

Verified date February 2022
Source Stony Brook University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 19, 2022
Est. primary completion date January 19, 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. 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 Design


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.
Placebo Capsule
Placebo capsules consumed by subjects as described in "Placebo Comparator" 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 One week following each treatment
Secondary Change in Activated Partial Thromboplastin Time One week following each treatment
Secondary Change in Thrombin Time One week following each treatment
Secondary Change in Reptilase Time One week following each treatment
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