AnxietyNCT06128512
Auricular Acupuncture Efficacy for Medical Students' Examination Anxiety
A study testing Auricular acupuncture in people with Anxiety and Anxiety, Exam, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Anxiety is a natural human response when facing challenging circumstances or threats to oneself. It is highly prevalent, estimated to range from 3.8% to 25%. Anxiety significantly impacts daily life and the overall quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety, Anxiety, Exam
- What is being tested?
- Auricular acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Nov 2023to 28 Apr 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medical students preparing to take an examination for a course experience anxiety with a STAI-Y1 score of 40 or higher.
- Voluntary informed consent.
Who cannot join
- Currently experiencing additional anxiety alongside the impending examination anxiety.
- Using stimulants within 24 hours prior.
- Recent use of any drugs impacting intervention outcomes including psychotropic medications, blood pressure, and heart rate-affecting medications.
- History of alcohol or substance addiction.
- History of cardiac and neuropsychiatric disorders.
- Prior experience with auricular acupuncture.
Show all 11Show fewer
- History of hypersensitivity reactions to any form of acupuncture with needles.
- Existing injuries or lesions at the acupoints being investigated in this study.
- Presence of severe medical conditions (e.g., cardiovascular, hepatic, renal, or others) that could potentially influence treatment outcomes as assessed by researchers.
- Currently enrolled in another intervention study.
- Pregnancy or lactating.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Evaluating the Efficacy of Auricular Acupuncture in Reducing Examination Anxiety Among Medical Students
Anxiety is a natural human response when facing challenging circumstances or threats to oneself. It is highly prevalent, estimated to range from 3.8% to 25%. Anxiety significantly impacts daily life and the overall quality of life. Of particular concern is the potential for anxiety to increase cardiovascular risk factors such as hypertension, a higher incidence of heart disease, and premature mortality.
Anxiety occurs in nearly everyone, but university students are particularly prone to experiencing anxiety and higher levels of mental stress compared to the general population. This trend is notably pronounced among medical students, a group with a significantly higher prevalence of anxiety that can reach as high as 90%. Multiple factors contribute to this anxiety and stress, notably the pressure of academic examinations.
Several studies suggest that acupuncture not only positively affects anxiety but also has fewer side effects compared to pharmacological treatments. Among these, a form of acupuncture known as auricular acupuncture (AA) is considered safe and has demonstrated effectiveness in reducing pre-surgical and dental anxiety. However, evidence supporting its effectiveness in reducing examination anxiety among medical students remains insufficient. Hence, in this study, we have designed a randomized controlled trial, including a placebo arm, to establish the efficacy and safety of AA in addressing this issue.
Read the detailed description
Medical students with examination anxiety, identified by a score equal to 40 or more on the STAI-Y1 scale, will be selected and randomly allocated into two groups: the intervention group (AA group) and the placebo group (Sham-AA), at a 1:1 allocation ratio.
The intervention will be carried out 24 hours before the examination and will be monitored until the students complete the test. In the AA group, AA devices will be utilized, while adhesive patches without needles will be used in the Sham-AA group.
Data regarding anxiety levels will be recorded through scores obtained from the STAI-Y1 questionnaire and VAS-100; heart rate, diastolic blood pressure, systolic blood pressure, examination scores, and adverse events will also be evaluated at various intervals.
- Conditions
- Anxiety, Anxiety, Exam
- Being tested
- Auricular acupuncture, Sham Auricular acupuncture
- Keywords
- anxiety, examination anxiety, acupuncture, auricular acupuncture, traditional medicine
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureOther
Auricular acupuncture is administered 24 hours before the examination using patches, each possessing a square shape with a side length of 10 mm, coupled with a sterilized needle measuring 0.25 x 1.3 mm. Four acupoints are selected on one ear, including the Master cerebral point, Tranquilizer point, Relaxation point, and Heart point (CO15). The patch containing the needle will remain in place until the student completes the examination.
Sham Auricular acupunctureOther
Sham Auricular acupuncture is administered 24 hours before the examination using patches, each possessing a square shape with a side length of 10 mm, without a needle. Four acupoints are selected on one ear, including the Master cerebral point, Tranquilizer point, Relaxation point, and Heart point (CO15). The patch will remain in place until the student completes the examination.
| Study group | Role | What they receive |
|---|---|---|
| AA | Experimental | Auricular acupuncture (AA) 24 hours before the examination. Receives: Other: Auricular acupuncture |
| Sham-AA | Sham comparator | Sham Auricular acupuncture (Sham-AA) 24 hours before the examination. Receives: Other: Sham Auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score
The STAI-Y1 comprises 20 questions, each rated on a 4-point scale from 1 "not at all" to 4 "very much so". Therefore, the STAI-Y1 score ranges from 20 to 80, with higher scores indicating increased levels of anxiety.
Measured: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Secondary outcomes (6)
Changes in Visual Analog Scale (VAS) score for anxiety
The VAS includes a 100mm line with endpoints labeled from "no anxiety" to "greatest anxiety ever experienced". Participants will mark on the line the point that represents their current level of anxiety. The VAS score ranges from 0 to 100, with higher scores indicating increased levels of anxiety.
Measured: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in Diastolic Blood Pressure
Diastolic blood pressure is measured using an electronic device, in units of mmHg, conducted by investigators. The higher the value, the higher the diastolic blood pressure.
Measured: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in Systolic Blood Pressure
Systolic blood pressure is measured using an electronic device, in units of mmHg, conducted by investigators. The higher the value, the higher the systolic blood pressure.
Measured: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in heart rate
Heart rate is measured using an electronic device, in units of beats per minute, conducted by investigators. The higher the value, the faster the heart rate.
Measured: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
The examination score
The examination scores will be recorded after the students receive their test results. The scoring scale ranges from 0 to 10 points. Higher scores indicate a better performance on the examination.
Measured: up to 1 month
Proportion of intervention-related adverse effects
Anticipated adverse events (AEs) from auricular acupuncture (AA) may comprise pain at the insertion site, local discomfort, skin irritation (itching and redness), inflammation, bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions.
Moreover, any unanticipated AEs related to AA will be recorded and observed.
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Nov 2023
- Primary completion27 Mar 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128512
- Sponsor's protocol ID
- 698/HDDD-DHYD
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Remes O, Brayne C, van der Linde R, Lafortune L. A systematic review of reviews on the prevalence of anxiety disorders in adult populations. Brain Behav. 2016 Jun 5;6(7):e00497. doi: 10.1002/brb3.497. eCollection 2016 Jul.
PubMed 27458547Roest AM, Martens EJ, de Jonge P, Denollet J. Anxiety and risk of incident coronary heart disease: a meta-analysis. J Am Coll Cardiol. 2010 Jun 29;56(1):38-46. doi: 10.1016/j.jacc.2010.03.034.
PubMed 20620715Mboya IB, John B, Kibopile ES, Mhando L, George J, Ngocho JS. Factors associated with mental distress among undergraduate students in northern Tanzania. BMC Psychiatry. 2020 Jan 29;20(1):28. doi: 10.1186/s12888-020-2448-1.
PubMed 31996200Fares J, Al Tabosh H, Saadeddin Z, El Mouhayyar C, Aridi H. Stress, Burnout and Coping Strategies in Preclinical Medical Students. N Am J Med Sci. 2016 Feb;8(2):75-81. doi: 10.4103/1947-2714.177299.
PubMed 27042604Li M, Li WQ, Li LMW. Sensitive Periods of Moving on Mental Health and Academic Performance Among University Students. Front Psychol. 2019 Jun 13;10:1289. doi: 10.3389/fpsyg.2019.01289. eCollection 2019.
PubMed 31263436Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.
PubMed 25254059Amorim D, Amado J, Brito I, Fiuza SM, Amorim N, Costeira C, Machado J. Acupuncture and electroacupuncture for anxiety disorders: A systematic review of the clinical research. Complement Ther Clin Pract. 2018 May;31:31-37. doi: 10.1016/j.ctcp.2018.01.008. Epub 2018 Jan 31.
PubMed 29705474Karst M, Winterhalter M, Munte S, Francki B, Hondronikos A, Eckardt A, Hoy L, Buhck H, Bernateck M, Fink M. Auricular acupuncture for dental anxiety: a randomized controlled trial. Anesth Analg. 2007 Feb;104(2):295-300. doi: 10.1213/01.ane.0000242531.12722.fd.
PubMed 17242083Zanella S, Buccelletti F, Vassiliadis A, De Bortoli R, Visentini S, Pedrotti G, Azzalin L. Preoperative anxiety management: acupuncture vs. pharmacological treatment - A prospective study. Eur Rev Med Pharmacol Sci. 2022 Feb;26(3):900-905. doi: 10.26355/eurrev_202202_27999.
PubMed 35179756Michalek-Sauberer A, Gusenleitner E, Gleiss A, Tepper G, Deusch E. Auricular acupuncture effectively reduces state anxiety before dental treatment--a randomised controlled trial. Clin Oral Investig. 2012 Dec;16(6):1517-22. doi: 10.1007/s00784-011-0662-4. Epub 2012 Jan 6.
PubMed 22219023Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative anxiety. Anesth Analg. 2001 Nov;93(5):1178-80, table of contents. doi: 10.1097/00000539-200111000-00024.
PubMed 11682391Favre-Felix J, Laurent V, Branche P, Huissoud C, Raffin M, Pradat P, Aubrun F, Dziadzko M. Auricular Acupuncture for Preoperative Anxiety in Parturient Women with Scheduled Cesarean Section: A Randomized Placebo-Controlled Blind Study. J Integr Complement Med. 2022 Jul;28(7):569-578. doi: 10.1089/jicm.2021.0346. Epub 2022 Apr 8.
PubMed 35394895
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Auricular Acupuncture in Reducing Examination Anxiety Among Medical Students
- ClinicalTrials.gov ID
- NCT06128512
- Acronym / sponsor ID
- 698/HDDD-DHYD
- Conditions
- Anxiety, Anxiety, Exam
- Keywords
- anxiety, examination anxiety, acupuncture, auricular acupuncture, traditional medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 13 Nov 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.
Anxiety is a natural human response when facing challenging circumstances or threats to oneself. It is highly prevalent, estimated to range from 3.8% to 25%. Anxiety significantly impacts daily life and the overall quality of life. Of particular concern is the potential for anxiety to increase cardiovascular risk factors such as hypertension, a higher incidence of heart disease, and premature mortality.
Anxiety occurs in nearly everyone, but university students are particularly prone to experiencing anxiety and higher levels of mental stress compared to the general population. This trend is notably pronounced among medical students, a group with a significantly higher prevalence of anxiety that can reach as high as 90%. Multiple factors contribute to this anxiety and stress, notably the pressure of academic examinations.
Several studies suggest that acupuncture not only positively affects anxiety but also has fewer side effects compared to pharmacological treatments. Among these, a form of acupuncture known as auricular acupuncture (AA) is considered safe and has demonstrated effectiveness in reducing pre-surgical and dental anxiety. However, evidence supporting its effectiveness in reducing examination anxiety among medical students remains insufficient. Hence, in this study, we have designed a randomized controlled trial, including a placebo arm, to establish the efficacy and safety of AA in addressing this issue.
Detailed description
Medical students with examination anxiety, identified by a score equal to 40 or more on the STAI-Y1 scale, will be selected and randomly allocated into two groups: the intervention group (AA group) and the placebo group (Sham-AA), at a 1:1 allocation ratio.
The intervention will be carried out 24 hours before the examination and will be monitored until the students complete the test. In the AA group, AA devices will be utilized, while adhesive patches without needles will be used in the Sham-AA group.
Data regarding anxiety levels will be recorded through scores obtained from the STAI-Y1 questionnaire and VAS-100; heart rate, diastolic blood pressure, systolic blood pressure, examination scores, and adverse events will also be evaluated at various intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA | Experimental | Other: Auricular acupunctureAuricular acupuncture (AA) 24 hours before the examination. |
| Sham-AA | Sham comparator | Other: Sham Auricular acupunctureSham Auricular acupuncture (Sham-AA) 24 hours before the examination. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Medical students preparing to take an examination for a course experience anxiety with a STAI-Y1 score of 40 or higher.
- Voluntary informed consent.
Key exclusion criteria (11 listed)
- Currently experiencing additional anxiety alongside the impending examination anxiety.
- Using stimulants within 24 hours prior.
- Recent use of any drugs impacting intervention outcomes including psychotropic medications, blood pressure, and heart rate-affecting medications.
- History of alcohol or substance addiction.
- History of cardiac and neuropsychiatric disorders.
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 |
|---|---|---|
| Auricular acupunctureAuricular acupuncture is administered 24 hours before the examination using patches, each possessing a square shape with a side length of 10 mm, coupled with a sterilized needle measuring 0.25 x 1.3 mm. Four acupoints are selected on one ear, including the Master cerebral point, Tranquilizer point, Relaxation point, and Heart point (CO15). The patch containing the needle will remain in place until the student completes the examination. | Other | AA |
| Sham Auricular acupunctureSham Auricular acupuncture is administered 24 hours before the examination using patches, each possessing a square shape with a side length of 10 mm, without a needle. Four acupoints are selected on one ear, including the Master cerebral point, Tranquilizer point, Relaxation point, and Heart point (CO15). The patch will remain in place until the student completes the examination. | Other | Sham-AA |
Primary outcome
Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score
Time frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
The STAI-Y1 comprises 20 questions, each rated on a 4-point scale from 1 "not at all" to 4 "very much so". Therefore, the STAI-Y1 score ranges from 20 to 80, with higher scores indicating increased levels of anxiety.
6 secondary outcomes
Changes in Visual Analog Scale (VAS) score for anxiety
Time frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in Diastolic Blood Pressure
Time frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in Systolic Blood Pressure
Time frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in heart rate
Time frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
The examination score
Time frame: up to 1 month
Proportion of intervention-related adverse effects
Time frame: during 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 30 Apr 2024.
- Background: PubMed 27458547Remes O, Brayne C, van der Linde R, Lafortune L. A systematic review of reviews on the prevalence of anxiety disorders in adult populations. Brain Behav. 2016 Jun 5;6(7):e00497. doi: 10.1002/brb3.497. eCollection 2016 Jul.
- Background: PubMed 20620715Roest AM, Martens EJ, de Jonge P, Denollet J. Anxiety and risk of incident coronary heart disease: a meta-analysis. J Am Coll Cardiol. 2010 Jun 29;56(1):38-46. doi: 10.1016/j.jacc.2010.03.034.
- Background: PubMed 31996200Mboya IB, John B, Kibopile ES, Mhando L, George J, Ngocho JS. Factors associated with mental distress among undergraduate students in northern Tanzania. BMC Psychiatry. 2020 Jan 29;20(1):28. doi: 10.1186/s12888-020-2448-1.
- Background: PubMed 27042604Fares J, Al Tabosh H, Saadeddin Z, El Mouhayyar C, Aridi H. Stress, Burnout and Coping Strategies in Preclinical Medical Students. N Am J Med Sci. 2016 Feb;8(2):75-81. doi: 10.4103/1947-2714.177299.
- Background: PubMed 31263436Li M, Li WQ, Li LMW. Sensitive Periods of Moving on Mental Health and Academic Performance Among University Students. Front Psychol. 2019 Jun 13;10:1289. doi: 10.3389/fpsyg.2019.01289. eCollection 2019.
- Background: PubMed 25254059Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.
- Background: PubMed 29705474Amorim D, Amado J, Brito I, Fiuza SM, Amorim N, Costeira C, Machado J. Acupuncture and electroacupuncture for anxiety disorders: A systematic review of the clinical research. Complement Ther Clin Pract. 2018 May;31:31-37. doi: 10.1016/j.ctcp.2018.01.008. Epub 2018 Jan 31.
- Background: PubMed 17242083Karst M, Winterhalter M, Munte S, Francki B, Hondronikos A, Eckardt A, Hoy L, Buhck H, Bernateck M, Fink M. Auricular acupuncture for dental anxiety: a randomized controlled trial. Anesth Analg. 2007 Feb;104(2):295-300. doi: 10.1213/01.ane.0000242531.12722.fd.
- Background: PubMed 35179756Zanella S, Buccelletti F, Vassiliadis A, De Bortoli R, Visentini S, Pedrotti G, Azzalin L. Preoperative anxiety management: acupuncture vs. pharmacological treatment - A prospective study. Eur Rev Med Pharmacol Sci. 2022 Feb;26(3):900-905. doi: 10.26355/eurrev_202202_27999.
- Background: PubMed 22219023Michalek-Sauberer A, Gusenleitner E, Gleiss A, Tepper G, Deusch E. Auricular acupuncture effectively reduces state anxiety before dental treatment--a randomised controlled trial. Clin Oral Investig. 2012 Dec;16(6):1517-22. doi: 10.1007/s00784-011-0662-4. Epub 2012 Jan 6.
- Background: PubMed 11682391Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative anxiety. Anesth Analg. 2001 Nov;93(5):1178-80, table of contents. doi: 10.1097/00000539-200111000-00024.
- Background: PubMed 35394895Favre-Felix J, Laurent V, Branche P, Huissoud C, Raffin M, Pradat P, Aubrun F, Dziadzko M. Auricular Acupuncture for Preoperative Anxiety in Parturient Women with Scheduled Cesarean Section: A Randomized Placebo-Controlled Blind Study. J Integr Complement Med. 2022 Jul;28(7):569-578. doi: 10.1089/jicm.2021.0346. Epub 2022 Apr 8.
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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 Auricular acupuncture in people with Anxiety and Anxiety, Exam, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 11 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 30 Apr 2024. 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 Vietnam. 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?
Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score (time frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)). 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 NCT06128512, which also lists 12 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 30 Apr 2024.