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

NCT05272475 | Completed

• 1 other identifier: IRB2022-00036
• Study Type: interventional
• Target: 8
• 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 complete crossover study will investigate the impact of chamomile ingestion acutely on coagulation.

Conditions

Coagulation Disorder

Keywords

Coagulation; Chamomile

Outcome Measures

Primary Outcomes (1)

• Change in Prothrombin Time

  At two hours and four hours after the intervention

Secondary Outcomes (3)

• Change in Activated Partial Thromboplastin Time

  At two hours and four hours after the intervention

• Change in Thrombin Time

  At two hours and four hours after the intervention

• Change in Reptilase Time

  At two hours and four hours after the intervention

Study Arms (2)

Chamomile Tea

EXPERIMENTAL

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

Chamomile Extract Capsule

EXPERIMENTAL

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

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

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 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

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 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

• Kimura R, Schwartz JA, Romeiser JL, Senzel L, Galanakis D, Halper D, Bennett-Guerrero E. The Acute Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers: A Randomized Trial. J Appl Lab Med. 2024 May 2;9(3):468-476. doi: 10.1093/jalm/jfad120.

  PMID: 38300838 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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Our study is a crossover trial with subjects randomized to one of two treatment sequences: (A) a single dose of chamomile extract capsule followed by a single dose of chamomile tea or (B) a single dose of chamomile tea followed by a single dose of chamomile extract capsule. The study requires two visit days where subjects will consume their assigned chamomile preparation at the research site. To minimize any carryover effects, the two visits must be at least 3 days apart, and no more than 8 weeks apart. Randomization will be computer-generated by the biostatistician using the SAS software, and implemented using REDCap software

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 9, 2022
• Study Start: March 16, 2022
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)