Coagulation DisorderNCT05272475
The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
A study testing Chamomile Tea and Chamomile Extract Capsule in people with Coagulation Disorder, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- Chamomile Tea and Chamomile Extract Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to 12 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
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.
Read the detailed 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.
- Conditions
- Coagulation Disorder
- Being tested
- Chamomile Tea, Chamomile Extract Capsule
- Keywords
- Coagulation, Chamomile
- Medical subject headings
- Hemostatic Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chamomile TeaDietary supplement
Chamomile tea bags consumed by subjects as described in study arms section.
Chamomile Extract CapsuleDietary supplement
Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Chamomile Extract Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prothrombin Time
Measured: At two hours and four hours after the intervention
Secondary outcomes (3)
Change in Activated Partial Thromboplastin Time
Measured: At two hours and four hours after the intervention
Change in Thrombin Time
Measured: At two hours and four hours after the intervention
Change in Reptilase Time
Measured: At two hours and four hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start16 Mar 2022
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon Schwartz, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272475
- Sponsor's protocol ID
- IRB2022-00036
- Status last verified
- Jun 2022
- First submitted
- 27 Feb 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38300838
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05272475
- Acronym / sponsor ID
- IRB2022-00036
- Conditions
- Coagulation Disorder
- Keywords
- Coagulation, Chamomile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Chamomile Tea | Experimental | Dietary Supplement: Chamomile TeaSubjects 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. |
| Chamomile Extract Capsule | Experimental | Dietary Supplement: Chamomile Extract CapsuleSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chamomile TeaChamomile tea bags consumed by subjects as described in study arms section. | Dietary supplement | Chamomile Tea |
| Chamomile Extract CapsuleChamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section. | Dietary supplement | Chamomile Extract Capsule |
Primary outcome
Change in Prothrombin Time
Time frame: At two hours and four hours after the intervention
3 secondary outcomes
Change in Activated Partial Thromboplastin Time
Time frame: At two hours and four hours after the intervention
Change in Thrombin Time
Time frame: At two hours and four hours after the intervention
Change in Reptilase Time
Time frame: At two hours and four hours after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 38300838Kimura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chamomile Tea and Chamomile Extract Capsule in people with Coagulation Disorder, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prothrombin Time (time frame: At two hours and four hours after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.