Coagulation DisorderNCT05006378
Effect 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, placebo-controlled complete crossover study will investigate the impact of chamomile ingestion 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?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 19 Jan 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.
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 screening
- Females who are pregnant, breast-feeding, or lactating
Show all 38Show fewer
- 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
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, placebo-controlled complete crossover study will investigate the impact of chamomile ingestion on coagulation.
Read the 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.
- Conditions
- Coagulation Disorder
- Being tested
- Chamomile Tea, Chamomile Extract Capsule, Placebo 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.
Placebo CapsuleDietary supplement
Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Capsule | Placebo comparator | Not described Receives: 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. Receives: 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. 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: One week following each treatment
Secondary outcomes (3)
Change in Activated Partial Thromboplastin Time
Measured: One week following each treatment
Change in Thrombin Time
Measured: One week following each treatment
Change in Reptilase Time
Measured: One week following each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start31 Aug 2021
- Primary completion19 Jan 2022
- Study completion19 Jan 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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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
- NCT05006378
- Sponsor's protocol ID
- IRB2021-00314
- Status last verified
- Feb 2022
- First submitted
- 27 Jul 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37730613
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05006378
- Acronym / sponsor ID
- IRB2021-00314
- Conditions
- Coagulation Disorder
- Keywords
- Coagulation, Chamomile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 16 Aug 2021 (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, 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo Capsule | Placebo comparator | Dietary Supplement: Placebo Capsule |
| Chamomile Tea | Experimental | Dietary Supplement: Chamomile TeaSubjects 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. |
| Chamomile Extract Capsule | Experimental | Dietary Supplement: Chamomile Extract CapsuleSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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.
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 screening
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 |
| Placebo CapsulePlacebo capsules consumed by subjects as described in "Placebo Comparator" study arms section. | Dietary supplement | Placebo Capsule |
Primary outcome
Change in Prothrombin Time
Time frame: One week following each treatment
3 secondary outcomes
Change in Activated Partial Thromboplastin Time
Time frame: One week following each treatment
Change in Thrombin Time
Time frame: One week following each treatment
Change in Reptilase Time
Time frame: One week following each treatment
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 Feb 2022.
- Derived from this study: PubMed 37730613Schwartz 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.
- 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 2 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 Feb 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. Some participants in this study may receive a placebo. 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: One week following each treatment). 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 NCT05006378, 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 Feb 2022.