StressNCT05335850
Yoga for Mental Health in Parkinson's Patients
A study testing Isha Kriya, Nadi Shuddhi and Nada Yoga in people with Stress and Anxiety, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Isha Kriya, Nadi Shuddhi and Nada Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 25 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18
- Interested in attending the Breath, Sound, and Meditation Webinar
- Diagnosed with Parkinson's Disease
- PAS score of 12 or higher
- Able to read and comprehend English.
- Physically and mentally able to participate in the study procedure
- Currently residing in the United States.
Who cannot join
- Severe stage of PD
- Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
- Not able to self-consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02115
About this study
Official title: Meditation and Breathing for Mental Health in Parkinson's Disease Patient
This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Enrollment into the study will be ongoing until we are able to get a sufficient sample size as described in the "Statistical Consideration" section. Upon enrollment and randomization, surveys will be administered to both the intervention and control groups at four time-points: baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be collected weekly for 12 weeks for both groups.
Read the detailed description
Mental health issues caused by emotional and behavioral changes are common among people diagnosed with Parkinson's disease. Research from the Parkinson's Foundation's Parkinson's Outcomes Project has found that anxiety and depression play a key role in the disease's impact on people's quality of life. The death of dopamine-producing cells in the brain affects both movement and mood. As a result, both anxiety and depression are common non-motor symptoms of the disease rather than reactions to the diagnosis.
According to the Parkinson's Outcomes Project, during their illness:
- At least 50% of people will experience some form of depression
- At least 40% of people will experience an anxiety disorder
Forms of anxiety include Generalized Anxiety Disorder, Anxiety Attacks, Social Avoidance, and OCD1. Depression in Parkinson's disease often manifests as dissatisfaction with life, sadness, irritability, pessimism, and suicidal thoughts.
Meditative techniques have been shown to effectively reduce symptoms of anxiety and depression. Treating these non-motor symptoms can have a positive impact on people with Parkinson's disease by decreasing disability and improving their quality of life.
The purpose of this study is to investigate the impact of a set of simple, safe and scalable, digitally delivered meditation and breathing practices on the neuropsychological and movement disorder symptoms in patients with Parkinson's Disease over a period of 18-20 weeks. The intervention consists of a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Our recent studies using similar interventions have shown feasibility and acceptance as well as Improved perceived stress in healthy subjects.
The subjects will be randomized into two groups after they agree to participate in the study, an intervention group (Group 1) and a waitlisted control group (Group 2). Both groups will learn and practice the intervention for 12 weeks total.The intervention is made of a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Both groups will also take study surveys at 4 timepoints which are each 6 weeks apart (Baseline, T2, T3, and T4). The study surveys consist of an online survey and a clinician, phone administered survey.
This trial will be conducted in 2 phases:
Phase 1: If participants are in the intervention group, they will be asked to learn the practices first for 6 weeks, from T1-T2. They will be asked to complete weekly activity logs for these 6 weeks and the study survey at T2 (6 weeks after learning the intervention). Participants in the waitlisted control group will be asked to perform their regular daily routine as they wait to be enrolled into the intervention at T2 (6 weeks after Baseline). The waitlisted control group will also complete the study survey at T2.
Phase 2: After T2, the intervention group is no longer asked to attend weekly review webinars but they will continue to do weekly activity logs for 6 weeks until until T3. They will then complete the study survey at T3. After T3, they will not be sent any activity logs for the next 6 weeks until T4. At T4, they will be asked to complete the study survey and satisfaction survey. The waitlisted control group will begin the intervention at T2 and will attend review webinars for 6 weeks until T3 at which they will complete the study survey. After T3, they are no longer asked to attend weekly webinars but they will continue to do weekly activity logs for 6 weeks until until T4. At T4, they will be asked to complete the study survey and satisfaction survey.
- Conditions
- Stress, Anxiety, Depression, Parkinson Disease
- Being tested
- Isha Kriya, Nadi Shuddhi, Nada Yoga, Routine Daily Activity
- Keywords
- Stress, Anxiety, Depression, Parkinson's Disease, Meditation, Breathing, Isha Kriya, Yoga, Mental Health
- Medical subject headings
- Anxiety Disorders, Depression, Parkinson Disease, Respiratory Aspiration, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isha KriyaBehavioural
Isha Kriya is a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily.
Nadi ShuddhiBehavioural
Nadi Shuddhi is a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily.
Nada YogaBehavioural
Nada Yoga is a 6-minute meditation that uses sound to create balance and stability in the body and mind.
Routine Daily ActivityOther
Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.
Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Breathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Receives: Behavioral: Isha Kriya; Behavioral: Nadi Shuddhi; Behavioral: Nada Yoga |
| Waitlisted Control Group | Active comparator | This group will be asked to wait for 6 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Receives: Other: Routine Daily Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Compliance
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Participants completing at least 4 days of activity would be considered as compliant for that week.
Measured: For Phase 1 analysis: Baseline to week 6. For Phase 2 analysis: Baseline to week 18.
Change in Anxiety
Parkinson's Anxiety Scale (PAS) is a 12-item validated observer or patient-rated scale consisting of three subscales for persistent anxiety, episodic anxiety, and avoidance behavior in patients with Parkinson Disease. Participants are asked to rate on a scale of 0 (not or never) and 4 (severe or almost always).
Measured: For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.
Secondary outcomes (3)
Change in Perceived Stress Scale (PSS)
PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements.
Measured: For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.
Change in GRID-Hamilton Depression Scale (HAMD)
The GRID-HAMD-17 is used to measure the frequency and intensity of depressive symptoms. Participants are asked to rate frequency of each statement on a scale from "Absent or clinically insignificant" to "Almost all the time." Rating for intensity is on a scale from Absent to Very Severe.
Measured: For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.
Change in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
This is a four-part survey designed for patients with Parkinson Disease. Part I covers non-motor experiences of daily living, Part II covers motor experiences of daily living, Part III covers motor examination and Part IV covers motor complications.
Measured: For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start18 Oct 2022
- Primary completion12 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Crossover
- Model description
- Crossover Assignment A partial crossover model ensures that both experimental and waitlisted control group participants get to experience the effects of a proposed intervention. For our study, we are providing these practices as an intervention and both experimental and waitlisted control group participants get to experience the benefits of meditation and breathing exercises.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundar Subramaniam, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335850
- Sponsor's protocol ID
- 2022P000212
- Status last verified
- Feb 2025
- First submitted
- 6 Apr 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.
PubMed 32665843Rain M, Subramaniam B, Avti P, Mahajan P, Anand A. Can Yogic Breathing Techniques Like Simha Kriya and Isha Kriya Regulate COVID-19-Related Stress? Front Psychol. 2021 Apr 15;12:635816. doi: 10.3389/fpsyg.2021.635816. eCollection 2021.
PubMed 33935886Schneider RB, Auinger P, Tarolli CG, Iourinets J, Gil Diaz MC, Richard IH. Change in the Parkinson Anxiety Scale correlates with change in other clinical measures of anxiety over time. Clin Park Relat Disord. 2021 Dec 13;6:100126. doi: 10.1016/j.prdoa.2021.100126. eCollection 2022.
PubMed 34977549Rayapuraju A, Reed PU, Liu J, Chen M, Pratt M, Chase T, Novack V, Weintraub D, Simon DK, Subramaniam B. Meditation and breathwork on anxiety in Parkinson's disease: A pilot randomized controlled trial. J Parkinsons Dis. 2026 Aug 6:1877718X261463924. doi: 10.1177/1877718X261463924. Online ahead of print.
PubMed 42563479
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation and Breathing for Mental Health in Parkinson's Disease Patient
- ClinicalTrials.gov ID
- NCT05335850
- Acronym / sponsor ID
- 2022P000212
- Conditions
- Stress, Anxiety, Depression, Parkinson Disease
- Keywords
- Stress, Anxiety, Depression, Parkinson's Disease, Meditation, Breathing, Isha Kriya, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 19 Apr 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.
This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Enrollment into the study will be ongoing until we are able to get a sufficient sample size as described in the "Statistical Consideration" section. Upon enrollment and randomization, surveys will be administered to both the intervention and control groups at four time-points: baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be collected weekly for 12 weeks for both groups.
Detailed description
Mental health issues caused by emotional and behavioral changes are common among people diagnosed with Parkinson's disease. Research from the Parkinson's Foundation's Parkinson's Outcomes Project has found that anxiety and depression play a key role in the disease's impact on people's quality of life. The death of dopamine-producing cells in the brain affects both movement and mood. As a result, both anxiety and depression are common non-motor symptoms of the disease rather than reactions to the diagnosis.
According to the Parkinson's Outcomes Project, during their illness:
- At least 50% of people will experience some form of depression
- At least 40% of people will experience an anxiety disorder
Forms of anxiety include Generalized Anxiety Disorder, Anxiety Attacks, Social Avoidance, and OCD1. Depression in Parkinson's disease often manifests as dissatisfaction with life, sadness, irritability, pessimism, and suicidal thoughts.
Meditative techniques have been shown to effectively reduce symptoms of anxiety and depression. Treating these non-motor symptoms can have a positive impact on people with Parkinson's disease by decreasing disability and improving their quality of life.
The purpose of this study is to investigate the impact of a set of simple, safe and scalable, digitally delivered meditation and breathing practices on the neuropsychological and movement disorder symptoms in patients with Parkinson's Disease over a period of 18-20 weeks. The intervention consists of a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Our recent studies using similar interventions have shown feasibility and acceptance as well as Improved perceived stress in healthy subjects.
The subjects will be randomized into two groups after they agree to participate in the study, an intervention group (Group 1) and a waitlisted control group (Group 2). Both groups will learn and practice the intervention for 12 weeks total.The intervention is made of a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Both groups will also take study surveys at 4 timepoints which are each 6 weeks apart (Baseline, T2, T3, and T4). The study surveys consist of an online survey and a clinician, phone administered survey.
This trial will be conducted in 2 phases:
Phase 1: If participants are in the intervention group, they will be asked to learn the practices first for 6 weeks, from T1-T2. They will be asked to complete weekly activity logs for these 6 weeks and the study survey at T2 (6 weeks after learning the intervention). Participants in the waitlisted control group will be asked to perform their regular daily routine as they wait to be enrolled into the intervention at T2 (6 weeks after Baseline). The waitlisted control group will also complete the study survey at T2.
Phase 2: After T2, the intervention group is no longer asked to attend weekly review webinars but they will continue to do weekly activity logs for 6 weeks until until T3. They will then complete the study survey at T3. After T3, they will not be sent any activity logs for the next 6 weeks until T4. At T4, they will be asked to complete the study survey and satisfaction survey. The waitlisted control group will begin the intervention at T2 and will attend review webinars for 6 weeks until T3 at which they will complete the study survey. After T3, they are no longer asked to attend weekly webinars but they will continue to do weekly activity logs for 6 weeks until until T4. At T4, they will be asked to complete the study survey and satisfaction survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment A partial crossover model ensures that both experimental and waitlisted control group participants get to experience the effects of a proposed intervention. For our study, we are providing these practices as an intervention and both experimental and waitlisted control group participants get to experience the benefits of meditation and breathing exercises.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Isha Kriya, Behavioral: Nadi Shuddhi, Behavioral: Nada YogaBreathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). |
| Waitlisted Control Group | Active comparator | Other: Routine Daily ActivityThis group will be asked to wait for 6 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age above 18
- Interested in attending the Breath, Sound, and Meditation Webinar
- Diagnosed with Parkinson's Disease
- PAS score of 12 or higher
- Able to read and comprehend English.
Key exclusion criteria (3 listed)
- Severe stage of PD
- Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
- Not able to self-consent to participate in the 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 |
|---|---|---|
| Isha KriyaIsha Kriya is a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily. | Behavioural | Intervention Group |
| Nadi ShuddhiNadi Shuddhi is a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily. | Behavioural | Intervention Group |
| Nada YogaNada Yoga is a 6-minute meditation that uses sound to create balance and stability in the body and mind. | Behavioural | Intervention Group |
| Routine Daily ActivityParticipants in the control group are asked to perform routine daily activities until enrolled into the intervention arm. Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm. | Other | Waitlisted Control Group |
Primary outcome
Change in Compliance
Time frame: For Phase 1 analysis: Baseline to week 6. For Phase 2 analysis: Baseline to week 18.
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Participants completing at least 4 days of activity would be considered as compliant for that week.
Change in Anxiety
Time frame: For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.
Parkinson's Anxiety Scale (PAS) is a 12-item validated observer or patient-rated scale consisting of three subscales for persistent anxiety, episodic anxiety, and avoidance behavior in patients with Parkinson Disease. Participants are asked to rate on a scale of 0 (not or never) and 4 (severe or almost always).
3 secondary outcomes
Change in Perceived Stress Scale (PSS)
Time frame: For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.
Change in GRID-Hamilton Depression Scale (HAMD)
Time frame: For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.
Change in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.
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 6 Feb 2025.
- Background: PubMed 32665843Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.
- Background: PubMed 33935886Rain M, Subramaniam B, Avti P, Mahajan P, Anand A. Can Yogic Breathing Techniques Like Simha Kriya and Isha Kriya Regulate COVID-19-Related Stress? Front Psychol. 2021 Apr 15;12:635816. doi: 10.3389/fpsyg.2021.635816. eCollection 2021.
- Background: PubMed 34977549Schneider RB, Auinger P, Tarolli CG, Iourinets J, Gil Diaz MC, Richard IH. Change in the Parkinson Anxiety Scale correlates with change in other clinical measures of anxiety over time. Clin Park Relat Disord. 2021 Dec 13;6:100126. doi: 10.1016/j.prdoa.2021.100126. eCollection 2022.
- Derived from this study: PubMed 42563479Rayapuraju A, Reed PU, Liu J, Chen M, Pratt M, Chase T, Novack V, Weintraub D, Simon DK, Subramaniam B. Meditation and breathwork on anxiety in Parkinson's disease: A pilot randomized controlled trial. J Parkinsons Dis. 2026 Aug 6:1877718X261463924. doi: 10.1177/1877718X261463924. Online ahead of print.
- 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.
Balachundar Subramaniam, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isha Kriya, Nadi Shuddhi and Nada Yoga in people with Stress and Anxiety, run by Beth Israel Deaconess Medical Center 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 7 inclusion and 3 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 6 Feb 2025. 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 Compliance (time frame: For Phase 1 analysis: Baseline to week 6. For Phase 2 analysis: Baseline to week 18.). The study lists 2 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 NCT05335850, which also lists 4 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 6 Feb 2025.