Clinical trial NCT05006378: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coagulation Disorder
Keywords: Coagulation
Chamomile
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Change in Prothrombin Time
timeFrame: One week following each treatment
Secondary outcomes:
measure: Change in Activated Partial Thromboplastin Time
timeFrame: One week following each treatment
measure: Change in Thrombin Time
timeFrame: One week following each treatment
measure: Change in Reptilase Time
timeFrame: One week following each treatment
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
References: