Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

NCT05006378 | Completed

• 1 other identifier: IRB2021-00314
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation Disorder

Keywords

Coagulation; Chamomile

Outcome Measures

Primary Outcomes (1)

• Change in Prothrombin Time

  One week following each treatment

Secondary Outcomes (3)

• Change in Activated Partial Thromboplastin Time

  One week following each treatment

• Change in Thrombin Time

  One week following each treatment

• Change in Reptilase Time

  One week following each treatment

Study Arms (3)

Placebo Capsule

PLACEBO COMPARATOR

Dietary Supplement: Placebo Capsule

Chamomile Tea

EXPERIMENTAL

Subjects will consume three servings of chamomile tea throughout the day for the one-week treatment period. Each tea serving will be prepared using 3 grams of chamomile tea steeped in hot water according to the study protocol.

Dietary Supplement: Chamomile Tea

Chamomile Extract Capsule

EXPERIMENTAL

Subjects will consume three chamomile capsules throughout the day for the one-week treatment period. 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

Chamomile Tea DIETARY_SUPPLEMENT

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

Chamomile Tea

Chamomile Extract Capsule DIETARY_SUPPLEMENT

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

Chamomile Extract Capsule

Placebo Capsule DIETARY_SUPPLEMENT

Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section.

Placebo Capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

• Schwartz JA, Romeiser JL, Kimura R, Senzel L, Galanakis D, Halper D, Mena S, Bennett-Guerrero E. Effect of chamomile intake on blood coagulation tests in healthy volunteers: a randomized, placebo-controlled, crossover trial. Perioper Med (Lond). 2023 Sep 20;12(1):51. doi: 10.1186/s13741-023-00339-7.

  PMID: 37730613 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Thrombosis

Interventions

Chamomile extract

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 16, 2021
• Study Start: August 31, 2021
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)