Chronic Heart FailureNCT05862350
Effects of Lavender Essential Oil in Patients With Chronic Heart Failure
A study testing aromatherapy inhalation with lavender essential oil and aromatherapy inhalation with coconut essential oil. in people with Chronic Heart Failure, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The goal of the trial is to study the effects of lavender essential oil on sleep quality, anxiety, and fatigue in patients with chronic heart failure. The main questions it may answer are 1. effects of lavender essential oil on sleep quality 2. effects of lavender essential oil on anxiety 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- aromatherapy inhalation with lavender essential oil and aromatherapy inhalation with coconut essential oil.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2023to 30 Oct 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Met the diagnostic criteria of heart failure:cardiac function grade ⅱ-ⅲ, disease duration ≥6 months.
- Blood pressure ≥90/60mmH, heart rate ≥60 times/min.
- No malignant arrhythmia, no need for oxygen or mechanical ventilation.
- Pittsburgh sleep quality (PSQI) score > 5, State-trait anxiety scale (STAI) score 21-59.
- No nasal diseases, normal sense of smell.
- Normal hearing and language expression, able to communicate, volunteer to participate in this study.
Who cannot join
- Pregnant women.
- Suffering from physical pain diseases or combined with tumors and other serious diseases of the system
- A history of mental illness, the use of psychiatric or sedative hypnotic drugs within 1 month.
- Allergic constitution, allergic to lavender essential oil or coconut oil, suffering from allergic rhinitis, eczema, asthma and other respiratory diseases.
- Declined to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Lavender Essential Oil on Sleep Quality, Anxiety, and Fatigue in Patients With Chronic Heart Failure
The goal of the trial is to study the effects of lavender essential oil on sleep quality, anxiety, and fatigue in patients with chronic heart failure. The main questions it may answer are
- effects of lavender essential oil on sleep quality
- effects of lavender essential oil on anxiety
- effects of lavender essential oil on fatigue
Patients will be randomly divided into experimental and control groups, the control group will inhale essential coconut oil, and the experimental group will inhale lavender essential oil for four weeks. At baseline, on the 7th day, and 28th day, the sleep quality, anxiety, and fatigue will be evaluated.
Read the detailed description
Heart failure (HF)， a severe manifestation or advanced stage of various cardiac diseases, may seriously affect patients' quality of life because repeated hospitalizations lead to changes in work and living environment, changes in roles, economic burdens, sexual dysfunction, limitations of social life, and worries about maintaining life. Patients are often accompanied by mental problems such as anxiety, depression, fatigue, and sleep disorders, so their quality of life is low.
Currently, the treatment of CHF is mainly to improve physical symptoms and control complications. However, insufficient attention is drawn to mental and psychological problems such as anxiety, sleep disorders, and fatigue associated with CHF patients.
Patients with anxiety and sleep disturbances are generally treated with antipsychotic and sedative-hypnotic drugs. Although effective, this method also creates dependencies and tolerability with the long-term application. So in recent years, complementary and alternative medicine is a novel adjunctive therapy, including aromatherapy, and traditional medicine, which can improve the patient's health and maintain a calm inner peace.
The commonly used lavender essential oil (Lavandula angustifolia) is the least toxic and allergenic of all aromatic oils. The main components of lavender are linalool and linalool acetate, which act as sedative, anti-nociceptive, and antispasmodic by reducing sympathetic nerve activity and stimulating the parasympathetic nervous system activity. Aromatherapy using lavender essential oil has been widely used in patients with cancer, postpartum depression, pregnant women, blood purification, acute coronary syndrome, myocardial infarction, and quasi-coronary angiography. Studies have shown that aromatherapy using lavender essential oil can relieve anxiety and depression, reduce fatigue, and improve sleep quality, and it has not been found to cause associated adverse events and complications. It showed good safety, while the use of lavender essential oil in patients with CHF has been less studied.
This study intends to use aromatherapy for CHF patients to observe the effects of lavender essential oil inhalation on sleep quality, anxiety, and fatigue in CHF patients, in order to provide a new care method for CHF patients with all-round mental and physical self-management and improve the long-term quality of life of CHF patients.
- Conditions
- Chronic Heart Failure
- Being tested
- aromatherapy inhalation with lavender essential oil, aromatherapy inhalation with coconut essential oil.
- Keywords
- Chronic Heart Failure, lavender essential oil, sleep quality, Anxiety Disorders, Fatigue
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapy inhalation with lavender essential oilOther
patients in the experimental group will receive aromatherapy inhalation by 4 drops of 50% lavender essential oil，which is diluted with coconut essential oil， on the cotton chip in the diffuser clip for 8 hours each night during sleep
aromatherapy inhalation with coconut essential oil.Other
patients in the experimental group will receive aromatherapy inhalation by 4 drops of 100% coconut essential oil on the cotton chip in the diffuser clip for 8 hours each night during sleep
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy inhalation with lavender essential oil | Experimental | Patients in this group will receive aromatherapy inhalation with lavender essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day. Receives: Other: aromatherapy inhalation with lavender essential oil |
| Aromatherapy inhalation with coconut essential oil | Placebo comparator | Patients in this group will receive aromatherapy inhalation with coconut essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day. Receives: Other: aromatherapy inhalation with coconut essential oil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index assesses sleep quality, with scores ranging from 0 to 21. Higher scores mean poorer sleep quality.
Measured: at base line,7th day, 14th day, 28th day
Change of State-trait anxiety inventory
The State-trait anxiety inventory is used to assess state anxiety and trait anxiety on a scale from 20 to 80, with higher scores meaning more severe anxiety.
Measured: at base line,7th day, 14th day, 28th day
Change of the Fatigue Assessment Scale
The Fatigue Assessment Scale assesses fatigue levels on a scale of 10 to 50, with higher scores meaning more fatigue.
Measured: at base line,7th day, 14th day, 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start10 May 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingwen Hu, Master, Principal investigator, the First Afiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862350
- Sponsor's protocol ID
- XJTU1AF2022LSK-400
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drexler H, Coats AJ. Explaining fatigue in congestive heart failure. Annu Rev Med. 1996;47:241-56. doi: 10.1146/annurev.med.47.1.241.
PubMed 8712779Easton K, Coventry P, Lovell K, Carter LA, Deaton C. Prevalence and Measurement of Anxiety in Samples of Patients With Heart Failure: Meta-analysis. J Cardiovasc Nurs. 2016 Jul-Aug;31(4):367-79. doi: 10.1097/JCN.0000000000000265.
PubMed 25930162Kessing D, Denollet J, Widdershoven J, Kupper N. Fatigue and self-care in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2016 Aug;15(5):337-44. doi: 10.1177/1474515115575834. Epub 2015 Feb 25.
PubMed 25715645Steinhorn DM, Din J, Johnson A. Healing, spirituality and integrative medicine. Ann Palliat Med. 2017 Jul;6(3):237-247. doi: 10.21037/apm.2017.05.01. Epub 2017 May 22.
PubMed 28595441Cavanagh HM, Wilkinson JM. Biological activities of lavender essential oil. Phytother Res. 2002 Jun;16(4):301-8. doi: 10.1002/ptr.1103.
PubMed 12112282Cheraghbeigi N, Modarresi M, Rezaei M, Khatony A. Comparing the effects of massage and aromatherapy massage with lavender oil on sleep quality of cardiac patients: A randomized controlled trial. Complement Ther Clin Pract. 2019 May;35:253-258. doi: 10.1016/j.ctcp.2019.03.005. Epub 2019 Mar 8.
PubMed 31003666Dos Reis Lucena L, Dos Santos-Junior JG, Tufik S, Hachul H. Lavender essential oil on postmenopausal women with insomnia: Double-blind randomized trial. Complement Ther Med. 2021 Jun;59:102726. doi: 10.1016/j.ctim.2021.102726. Epub 2021 Apr 24.
PubMed 33905827Lee J, Hur MH. The Effects of Aroma Essential Oil Inhalation on Stress, Pain, and Sleep Quality in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2022 Feb;16(1):1-8. doi: 10.1016/j.anr.2021.11.002. Epub 2021 Dec 24.
PubMed 34954406Shammas RL, Marks CE, Broadwater G, Le E, Glener AD, Sergesketter AR, Cason RW, Rezak KM, Phillips BT, Hollenbeck ST. The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial. J Reconstr Microsurg. 2021 Jul;37(6):530-540. doi: 10.1055/s-0041-1724465. Epub 2021 Feb 6.
PubMed 33548936Moradi K, Ashtarian H, Danzima NY, Saeedi H, Bijan B, Akbari F, Mohammadi MM. Essential Oil from Citrus aurantium Alleviates Anxiety of Patients Undergoing Coronary Angiography: A Single-Blind, Randomized Controlled Trial. Chin J Integr Med. 2021 Mar;27(3):177-182. doi: 10.1007/s11655-020-3266-5. Epub 2020 Jun 22.
PubMed 32572778Hu J, Chong MS, Jia Y, Wu Y, Li J, Wang W. Effects of lavender essential oil inhalation on sleep quality and fatigue in patients with chronic heart failure: a randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jun 16;25(3):619-629. doi: 10.1093/eurjcn/zvag006.
PubMed 41499426
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lavender Essential Oil on Sleep Quality, Anxiety, and Fatigue in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05862350
- Acronym / sponsor ID
- XJTU1AF2022LSK-400
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, lavender essential oil, sleep quality, Anxiety Disorders, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 17 May 2023 (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.
The goal of the trial is to study the effects of lavender essential oil on sleep quality, anxiety, and fatigue in patients with chronic heart failure. The main questions it may answer are
- effects of lavender essential oil on sleep quality
- effects of lavender essential oil on anxiety
- effects of lavender essential oil on fatigue
Patients will be randomly divided into experimental and control groups, the control group will inhale essential coconut oil, and the experimental group will inhale lavender essential oil for four weeks. At baseline, on the 7th day, and 28th day, the sleep quality, anxiety, and fatigue will be evaluated.
Detailed description
Heart failure (HF)， a severe manifestation or advanced stage of various cardiac diseases, may seriously affect patients' quality of life because repeated hospitalizations lead to changes in work and living environment, changes in roles, economic burdens, sexual dysfunction, limitations of social life, and worries about maintaining life. Patients are often accompanied by mental problems such as anxiety, depression, fatigue, and sleep disorders, so their quality of life is low.
Currently, the treatment of CHF is mainly to improve physical symptoms and control complications. However, insufficient attention is drawn to mental and psychological problems such as anxiety, sleep disorders, and fatigue associated with CHF patients.
Patients with anxiety and sleep disturbances are generally treated with antipsychotic and sedative-hypnotic drugs. Although effective, this method also creates dependencies and tolerability with the long-term application. So in recent years, complementary and alternative medicine is a novel adjunctive therapy, including aromatherapy, and traditional medicine, which can improve the patient's health and maintain a calm inner peace.
The commonly used lavender essential oil (Lavandula angustifolia) is the least toxic and allergenic of all aromatic oils. The main components of lavender are linalool and linalool acetate, which act as sedative, anti-nociceptive, and antispasmodic by reducing sympathetic nerve activity and stimulating the parasympathetic nervous system activity. Aromatherapy using lavender essential oil has been widely used in patients with cancer, postpartum depression, pregnant women, blood purification, acute coronary syndrome, myocardial infarction, and quasi-coronary angiography. Studies have shown that aromatherapy using lavender essential oil can relieve anxiety and depression, reduce fatigue, and improve sleep quality, and it has not been found to cause associated adverse events and complications. It showed good safety, while the use of lavender essential oil in patients with CHF has been less studied.
This study intends to use aromatherapy for CHF patients to observe the effects of lavender essential oil inhalation on sleep quality, anxiety, and fatigue in CHF patients, in order to provide a new care method for CHF patients with all-round mental and physical self-management and improve the long-term quality of life of CHF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy inhalation with lavender essential oil | Experimental | Other: aromatherapy inhalation with lavender essential oilPatients in this group will receive aromatherapy inhalation with lavender essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day. |
| Aromatherapy inhalation with coconut essential oil | Placebo comparator | Other: aromatherapy inhalation with coconut essential oil.Patients in this group will receive aromatherapy inhalation with coconut essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Met the diagnostic criteria of heart failure:cardiac function grade ⅱ-ⅲ, disease duration ≥6 months.
- Blood pressure ≥90/60mmH, heart rate ≥60 times/min.
- No malignant arrhythmia, no need for oxygen or mechanical ventilation.
- Pittsburgh sleep quality (PSQI) score > 5, State-trait anxiety scale (STAI) score 21-59.
- No nasal diseases, normal sense of smell.
Key exclusion criteria (5 listed)
- Pregnant women.
- Suffering from physical pain diseases or combined with tumors and other serious diseases of the system
- A history of mental illness, the use of psychiatric or sedative hypnotic drugs within 1 month.
- Allergic constitution, allergic to lavender essential oil or coconut oil, suffering from allergic rhinitis, eczema, asthma and other respiratory diseases.
- Declined to participate in this study.
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 |
|---|---|---|
| aromatherapy inhalation with lavender essential oilpatients in the experimental group will receive aromatherapy inhalation by 4 drops of 50% lavender essential oil，which is diluted with coconut essential oil， on the cotton chip in the diffuser clip for 8 hours each night during sleep | Other | Aromatherapy inhalation with lavender essential oil |
| aromatherapy inhalation with coconut essential oil.patients in the experimental group will receive aromatherapy inhalation by 4 drops of 100% coconut essential oil on the cotton chip in the diffuser clip for 8 hours each night during sleep | Other | Aromatherapy inhalation with coconut essential oil |
Primary outcome
Change of Pittsburgh Sleep Quality Index
Time frame: at base line,7th day, 14th day, 28th day
The Pittsburgh Sleep Quality Index assesses sleep quality, with scores ranging from 0 to 21. Higher scores mean poorer sleep quality.
Change of State-trait anxiety inventory
Time frame: at base line,7th day, 14th day, 28th day
The State-trait anxiety inventory is used to assess state anxiety and trait anxiety on a scale from 20 to 80, with higher scores meaning more severe anxiety.
Change of the Fatigue Assessment Scale
Time frame: at base line,7th day, 14th day, 28th day
The Fatigue Assessment Scale assesses fatigue levels on a scale of 10 to 50, with higher scores meaning more fatigue.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 8712779Drexler H, Coats AJ. Explaining fatigue in congestive heart failure. Annu Rev Med. 1996;47:241-56. doi: 10.1146/annurev.med.47.1.241.
- Background: PubMed 25930162Easton K, Coventry P, Lovell K, Carter LA, Deaton C. Prevalence and Measurement of Anxiety in Samples of Patients With Heart Failure: Meta-analysis. J Cardiovasc Nurs. 2016 Jul-Aug;31(4):367-79. doi: 10.1097/JCN.0000000000000265.
- Background: PubMed 25715645Kessing D, Denollet J, Widdershoven J, Kupper N. Fatigue and self-care in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2016 Aug;15(5):337-44. doi: 10.1177/1474515115575834. Epub 2015 Feb 25.
- Background: PubMed 28595441Steinhorn DM, Din J, Johnson A. Healing, spirituality and integrative medicine. Ann Palliat Med. 2017 Jul;6(3):237-247. doi: 10.21037/apm.2017.05.01. Epub 2017 May 22.
- Background: PubMed 12112282Cavanagh HM, Wilkinson JM. Biological activities of lavender essential oil. Phytother Res. 2002 Jun;16(4):301-8. doi: 10.1002/ptr.1103.
- Background: PubMed 31003666Cheraghbeigi N, Modarresi M, Rezaei M, Khatony A. Comparing the effects of massage and aromatherapy massage with lavender oil on sleep quality of cardiac patients: A randomized controlled trial. Complement Ther Clin Pract. 2019 May;35:253-258. doi: 10.1016/j.ctcp.2019.03.005. Epub 2019 Mar 8.
- Background: PubMed 33905827Dos Reis Lucena L, Dos Santos-Junior JG, Tufik S, Hachul H. Lavender essential oil on postmenopausal women with insomnia: Double-blind randomized trial. Complement Ther Med. 2021 Jun;59:102726. doi: 10.1016/j.ctim.2021.102726. Epub 2021 Apr 24.
- Background: PubMed 34954406Lee J, Hur MH. The Effects of Aroma Essential Oil Inhalation on Stress, Pain, and Sleep Quality in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2022 Feb;16(1):1-8. doi: 10.1016/j.anr.2021.11.002. Epub 2021 Dec 24.
- Background: PubMed 33548936Shammas RL, Marks CE, Broadwater G, Le E, Glener AD, Sergesketter AR, Cason RW, Rezak KM, Phillips BT, Hollenbeck ST. The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial. J Reconstr Microsurg. 2021 Jul;37(6):530-540. doi: 10.1055/s-0041-1724465. Epub 2021 Feb 6.
- Background: PubMed 32572778Moradi K, Ashtarian H, Danzima NY, Saeedi H, Bijan B, Akbari F, Mohammadi MM. Essential Oil from Citrus aurantium Alleviates Anxiety of Patients Undergoing Coronary Angiography: A Single-Blind, Randomized Controlled Trial. Chin J Integr Med. 2021 Mar;27(3):177-182. doi: 10.1007/s11655-020-3266-5. Epub 2020 Jun 22.
- Derived from this study: PubMed 41499426Hu J, Chong MS, Jia Y, Wu Y, Li J, Wang W. Effects of lavender essential oil inhalation on sleep quality and fatigue in patients with chronic heart failure: a randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jun 16;25(3):619-629. doi: 10.1093/eurjcn/zvag006.
- 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.
Jingwen Hu, Master principal investigator
the First Afiliated Hospital of Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy inhalation with lavender essential oil and aromatherapy inhalation with coconut essential oil. in people with Chronic Heart Failure, run by First Affiliated Hospital Xi'an Jiaotong University.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Hu, Master (008602985383801, jingwenhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pittsburgh Sleep Quality Index (time frame: at base line,7th day, 14th day, 28th day). The study lists 3 primary outcomes in all. 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 NCT05862350, which also lists 11 linked publications.
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 17 May 2023.