AgingNCT07567976
Tai Chi Intervention for Balance Function in Older Adults: Predictive and Modifying Roles of Circadian Age
A study testing Tai Chi Exercise and Health Education in people with Aging and Postural Balance, run by Zhide Liang.
Trial summary
This study investigates the effects of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Participants are randomly assigned to either a Tai Chi exercise group or a health education control group. The primary outcome is balance function measured by the Berg Balance Scale. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Postural Balance, Accidental Falls
- What is being tested?
- Tai Chi Exercise and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 55 years or older
- Community-dwelling
- Able to walk independently (assistive devices such as canes are permitted)
- Berg Balance Scale (BBS) score ≤52 at screening
- Able to understand and follow verbal instructions
- Willing to wear a wrist accelerometer continuously for 7 days at baseline
Show all 9Show fewer
- Willing to accept random group assignment
- Willing to undergo blood collection during the study
- Provides written informed consent
Who cannot join
- Regular Tai Chi or yoga practice (more than once per week) within the past 6 months
- Severe cognitive impairment (Montreal Cognitive Assessment [MoCA] score <20 at screening, or previously diagnosed dementia)
- Unstable cardiovascular disease (myocardial infarction, stroke, or hospitalization within the past 3 months)
- Severe musculoskeletal disease that limits exercise participation
- Neurological diseases affecting balance (e.g., Parkinson's disease, severe peripheral neuropathy)
- Currently participating in another exercise intervention study
Show all 10Show fewer
- Planned surgery or extended absence during the study period
- Contraindications to functional near-infrared spectroscopy (fNIRS) examination (e.g., scalp injury, metallic implants in the head region)
- Severe psychiatric illness (e.g., schizophrenia, bipolar disorder)
- Considered unable to safely participate in moderate-intensity physical activity as judged by the study physician or attending healthcare provider
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Tai Chi on Balance Function in Community-Dwelling Older Adults: A Randomized Controlled Trial Examining the Predictive and Modifying Roles of Circadian Age, With Multi-Omics and Brain Function Assessments
This study investigates the effects of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Participants are randomly assigned to either a Tai Chi exercise group or a health education control group. The primary outcome is balance function measured by the Berg Balance Scale. Secondary outcomes include physical function, psychological well-being, cognitive function, and sleep quality. The study also explores the predictive and modifying roles of baseline circadian age on intervention outcomes.
Read the detailed description
BACKGROUND AND RATIONALE Falls are a leading cause of injury and disability in older adults, and balance dysfunction is a key modifiable risk factor. Tai Chi, a traditional Chinese mind-body exercise, has been shown to improve balance, reduce fall risk, and benefit cognitive health in older populations. However, individual variability in response to Tai Chi remains poorly understood, and the biological mechanisms underlying its benefits are incompletely characterized.
Circadian rhythm disruption has emerged as a hallmark of biological aging. The investigators have developed and validated a circadian age (CircAge) assessment system based on the UK Biobank cohort (N>90,000), which independently predicts mortality risk. Whether individuals with accelerated circadian aging benefit more from Tai Chi intervention is unknown. This trial addresses this gap by integrating circadian age assessment with multi-modal outcome evaluations.
OBJECTIVES The primary objective is to evaluate the effect of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Secondary objectives are to assess effects on physical function, psychological health, cognitive function, and sleep quality. Exploratory objectives are to examine the predictive and modifying roles of baseline circadian age acceleration on intervention outcomes.
STUDY DESIGN This is a two-arm parallel, single-blind (assessor-blinded) randomized controlled trial. Ninety community-dwelling older adults are randomly allocated 1:1 to a Tai Chi group or a health education control group. Randomization is computer-generated using variable block sizes, stratified by sex and baseline Berg Balance Scale score (≤45 vs >45). Allocation concealment is maintained via sequentially numbered opaque sealed envelopes. Outcome assessors are blinded to group allocation. After the 12-week intervention, the control group is offered free Tai Chi classes to ensure ethical equipoise.
ASSESSMENT SCHEDULE Wrist-worn accelerometer (ActiGraph) recordings are collected at baseline over 7 consecutive days for circadian age computation. All baseline accelerometer recordings are completed prior to randomization. Full outcome assessments are conducted at baseline (week 0) and at the end of intervention (week 12). A streamlined midpoint assessment (week 6) includes only the Berg Balance Scale and Timed Up and Go test. Fasting blood samples for routine clinical chemistry are collected at week 0 and week 12.
STATISTICAL ANALYSIS A sample size of 90 (45 per group) provides >80% power to detect a standardized effect size of d=0.50 in Berg Balance Scale change at week 12, assuming α=0.05 (two-sided) and 20% attrition. The primary analysis follows the intention-to-treat principle using linear mixed-effects models adjusted for baseline score, age, sex, and circadian age acceleration, with class as a random effect for the Tai Chi group. Exploratory analyses include circadian age × group interaction terms.
LONG-TERM FOLLOW-UP After the 12-week intervention, participants are invited to enter a long-term health database with periodic follow-ups tracking balance function, fall events, and overall health status.
- Conditions
- Aging, Postural Balance, Accidental Falls
- Being tested
- Tai Chi Exercise, Health Education
- Keywords
- Tai Chi, Tai Ji Quan, Mind-Body Exercise, Older Adults, Fall Prevention, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ExerciseBehavioural
Yang-style 24-form Tai Chi taught by a nationally certified master coach. Classes are offered five days per week, with participants required to attend at least three sessions per week, for a total of 12 weeks (target: ≥36 sessions). Each 60-minute session includes a 10-minute warm-up, 35 minutes of Tai Chi practice, 10 minutes of cool-down (including standing meditation and breathing exercises), and 5 minutes for questions and home practice reminders. Class size is limited to 10-15 participants.
Health EducationBehavioural
Structured health education program delivered by professional medical and health management staff. Seminars cover topics including nutrition and dietary guidance, chronic disease management (hypertension, diabetes), fall prevention strategies, safe medication use, and general health literacy for older adults. The intervention runs for 12 weeks. Participants receive the same health screening, evaluation, and feedback benefits as the Tai Chi group. Free Tai Chi classes are offered to this group after the intervention period ends.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Group | Experimental | Participants in this group receive instruction in Yang-style 24-form Tai Chi from a nationally certified master coach. Tai Chi classes are offered five days per week, and participants are required to attend at least three sessions per week. Each session lasts 60 minutes, including warm-up, Tai Chi practice, cool-down, and Q\&A. The intervention duration is 12 weeks. Class size is limited to 10-15 participants to ensure individualized guidance. Receives: Behavioral: Tai Chi Exercise |
| Health Education Control Group | Active comparator | Participants in this group attend health education seminars led by professional medical and health management staff. Seminar topics include nutrition, chronic disease management, fall prevention, and safe medication use. The intervention duration is 12 weeks. After the intervention ends, this group is offered free Tai Chi classes to ensure ethical equipoise. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Berg Balance Scale (BBS) Score
The Berg Balance Scale (BBS) is a 14-item performance-based measure of static and dynamic balance. Each item is scored 0-4 based on the participant's ability to perform tasks such as sitting to standing, transfers, standing unsupported with eyes closed, turning, and single-leg stance. Total scores range from 0 to 56, with higher scores indicating better balance function. Lower scores are associated with increased fall risk.
Measured: Change from baseline to end of intervention, up to 12 weeks
Secondary outcomes (11)
Change in Timed Up and Go (TUG) Test
Functional mobility and dynamic balance test. Participants stand from an armed chair, walk 3 meters, turn, walk back, and sit down. Time to complete the task is recorded in seconds. Longer times indicate poorer mobility and higher fall risk.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Grip Strength
Maximum grip strength measured using a handheld dynamometer, in kilograms. Three trials per hand; maximum value recorded. Higher values indicate greater muscle strength.
Time Frame: Change from baseline to 12 weeks
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Balance Performance Measured by InBody Balance Trainer
Static balance assessed via center-of-pressure trajectory recorded by the InBody Balance Trainer during quiet standing, reported in millimeters. Shorter path length indicates better postural control.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Single-Leg Eye-Closed Standing Time
Static balance is assessed by measuring the time (in seconds) participants can maintain single-leg standing with eyes closed. Both legs are tested. Longer times indicate better static balance and proprioception.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Vertical Jump Height
Vertical jump test measures lower-extremity power and neuromuscular function. Participants perform three consecutive jumps, and the maximum jump height (in centimeters) is recorded.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Reaction Time
Reaction time test measures central nervous system processing speed using a portable reaction time device. Faster reaction times are associated with lower fall risk and better cognitive processing.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Activities-Specific Balance Confidence (ABC) Scale
The ABC Scale is a 16-item self-report measure of balance confidence during specific activities (e.g., walking, reaching, climbing stairs). Each item is rated 0-100%, with higher scores indicating greater balance confidence.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Geriatric Depression Scale (GDS-15) Score
The 15-item Geriatric Depression Scale (GDS-15) screens for depressive symptoms in older adults. Total scores range from 0 to 15, with scores ≥5 suggesting depression.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Generalized Anxiety Disorder Scale (GAD-7) Score
The 7-item Generalized Anxiety Disorder Scale (GAD-7) measures anxiety severity. Total scores range from 0 to 21, with scores ≥10 indicating moderate-to-severe anxiety.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Shape Trail Test (STT) Part A and Part B Completion Time
The Shape Trail Test (STT) is a culturally adapted variant of the Trail Making Test developed for Chinese populations, avoiding reliance on the Latin alphabet. In Part A, participants connect numbered circles in sequence; in Part B, they alternate between circles and squares while ignoring the numbers. Completion time for each part is recorded in seconds, with longer times indicating poorer processing speed and executive function. STT-A and STT-B completion times are reported separately.
Measured: Change from baseline to end of intervention, up to 12 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality over the past month. Total scores range from 0 to 21, with scores >5 indicating poor sleep quality.
Measured: Change from baseline to end of intervention, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized controlled trial. Participants are randomly assigned in a 1:1 ratio to either the Tai Chi intervention group or the health education control group. Both groups undergo the intervention concurrently for 12 weeks. After the intervention, the control group is offered free Tai Chi classes to ensure ethical equipoise.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhide Liang
- Sponsor type
- University, hospital or other
- Collaborators
- Macao Polytechnic University
- Responsible party
- Sponsor-investigator, Zhide Liang, Hainan Medical College
- Investigators
- Baichao Xu, PhD, Study director, Hainan Medical CollegeZiheng Ning, PhD, Study director, Macao Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567976
- Sponsor's protocol ID
- HainanMC-TaiChi-2026-001
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tai Chi on Balance Function in Community-Dwelling Older Adults: A Randomized Controlled Trial Examining the Predictive and Modifying Roles of Circadian Age, With Multi-Omics and Brain Function Assessments
- ClinicalTrials.gov ID
- NCT07567976
- Acronym / sponsor ID
- HainanMC-TaiChi-2026-001
- Conditions
- Aging, Postural Balance, Accidental Falls
- Keywords
- Tai Chi, Tai Ji Quan, Mind-Body Exercise, Older Adults, Fall Prevention, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhide LiangUniversity, hospital or other
- Collaborators
- Macao Polytechnic University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 May 2026 (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 investigates the effects of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Participants are randomly assigned to either a Tai Chi exercise group or a health education control group. The primary outcome is balance function measured by the Berg Balance Scale. Secondary outcomes include physical function, psychological well-being, cognitive function, and sleep quality. The study also explores the predictive and modifying roles of baseline circadian age on intervention outcomes.
Detailed description
BACKGROUND AND RATIONALE Falls are a leading cause of injury and disability in older adults, and balance dysfunction is a key modifiable risk factor. Tai Chi, a traditional Chinese mind-body exercise, has been shown to improve balance, reduce fall risk, and benefit cognitive health in older populations. However, individual variability in response to Tai Chi remains poorly understood, and the biological mechanisms underlying its benefits are incompletely characterized.
Circadian rhythm disruption has emerged as a hallmark of biological aging. The investigators have developed and validated a circadian age (CircAge) assessment system based on the UK Biobank cohort (N>90,000), which independently predicts mortality risk. Whether individuals with accelerated circadian aging benefit more from Tai Chi intervention is unknown. This trial addresses this gap by integrating circadian age assessment with multi-modal outcome evaluations.
OBJECTIVES The primary objective is to evaluate the effect of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Secondary objectives are to assess effects on physical function, psychological health, cognitive function, and sleep quality. Exploratory objectives are to examine the predictive and modifying roles of baseline circadian age acceleration on intervention outcomes.
STUDY DESIGN This is a two-arm parallel, single-blind (assessor-blinded) randomized controlled trial. Ninety community-dwelling older adults are randomly allocated 1:1 to a Tai Chi group or a health education control group. Randomization is computer-generated using variable block sizes, stratified by sex and baseline Berg Balance Scale score (≤45 vs >45). Allocation concealment is maintained via sequentially numbered opaque sealed envelopes. Outcome assessors are blinded to group allocation. After the 12-week intervention, the control group is offered free Tai Chi classes to ensure ethical equipoise.
ASSESSMENT SCHEDULE Wrist-worn accelerometer (ActiGraph) recordings are collected at baseline over 7 consecutive days for circadian age computation. All baseline accelerometer recordings are completed prior to randomization. Full outcome assessments are conducted at baseline (week 0) and at the end of intervention (week 12). A streamlined midpoint assessment (week 6) includes only the Berg Balance Scale and Timed Up and Go test. Fasting blood samples for routine clinical chemistry are collected at week 0 and week 12.
STATISTICAL ANALYSIS A sample size of 90 (45 per group) provides >80% power to detect a standardized effect size of d=0.50 in Berg Balance Scale change at week 12, assuming α=0.05 (two-sided) and 20% attrition. The primary analysis follows the intention-to-treat principle using linear mixed-effects models adjusted for baseline score, age, sex, and circadian age acceleration, with class as a random effect for the Tai Chi group. Exploratory analyses include circadian age × group interaction terms.
LONG-TERM FOLLOW-UP After the 12-week intervention, participants are invited to enter a long-term health database with periodic follow-ups tracking balance function, fall events, and overall health status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized controlled trial. Participants are randomly assigned in a 1:1 ratio to either the Tai Chi intervention group or the health education control group. Both groups undergo the intervention concurrently for 12 weeks. After the intervention, the control group is offered free Tai Chi classes to ensure ethical equipoise.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Group | Experimental | Behavioral: Tai Chi ExerciseParticipants in this group receive instruction in Yang-style 24-form Tai Chi from a nationally certified master coach. Tai Chi classes are offered five days per week, and participants are required to attend at least three sessions per week. Each session lasts 60 minutes, including warm-up, Tai Chi practice, cool-down, and Q\&A. The intervention duration is 12 weeks. Class size is limited to 10-15 participants to ensure individualized guidance. |
| Health Education Control Group | Active comparator | Behavioral: Health EducationParticipants in this group attend health education seminars led by professional medical and health management staff. Seminar topics include nutrition, chronic disease management, fall prevention, and safe medication use. The intervention duration is 12 weeks. After the intervention ends, this group is offered free Tai Chi classes to ensure ethical equipoise. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 55 years or older
- Community-dwelling
- Able to walk independently (assistive devices such as canes are permitted)
- Berg Balance Scale (BBS) score ≤52 at screening
- Able to understand and follow verbal instructions
Key exclusion criteria (10 listed)
- Regular Tai Chi or yoga practice (more than once per week) within the past 6 months
- Severe cognitive impairment (Montreal Cognitive Assessment [MoCA] score <20 at screening, or previously diagnosed dementia)
- Unstable cardiovascular disease (myocardial infarction, stroke, or hospitalization within the past 3 months)
- Severe musculoskeletal disease that limits exercise participation
- Neurological diseases affecting balance (e.g., Parkinson's disease, severe peripheral neuropathy)
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 |
|---|---|---|
| Tai Chi ExerciseYang-style 24-form Tai Chi taught by a nationally certified master coach. Classes are offered five days per week, with participants required to attend at least three sessions per week, for a total of 12 weeks (target: ≥36 sessions). Each 60-minute session includes a 10-minute warm-up, 35 minutes of Tai Chi practice, 10 minutes of cool-down (including standing meditation and breathing exercises), and 5 minutes for questions and home practice reminders. Class size is limited to 10-15 participants. | Behavioural | Tai Chi Group |
| Health EducationStructured health education program delivered by professional medical and health management staff. Seminars cover topics including nutrition and dietary guidance, chronic disease management (hypertension, diabetes), fall prevention strategies, safe medication use, and general health literacy for older adults. The intervention runs for 12 weeks. Participants receive the same health screening, evaluation, and feedback benefits as the Tai Chi group. Free Tai Chi classes are offered to this group after the intervention period ends. | Behavioural | Health Education Control Group |
Primary outcome
Change in Berg Balance Scale (BBS) Score
Time frame: Change from baseline to end of intervention, up to 12 weeks
The Berg Balance Scale (BBS) is a 14-item performance-based measure of static and dynamic balance. Each item is scored 0-4 based on the participant's ability to perform tasks such as sitting to standing, transfers, standing unsupported with eyes closed, turning, and single-leg stance. Total scores range from 0 to 56, with higher scores indicating better balance function. Lower scores are associated with increased fall risk.
11 secondary outcomes
Change in Timed Up and Go (TUG) Test
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Grip Strength
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Balance Performance Measured by InBody Balance Trainer
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Single-Leg Eye-Closed Standing Time
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Vertical Jump Height
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Reaction Time
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Activities-Specific Balance Confidence (ABC) Scale
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Geriatric Depression Scale (GDS-15) Score
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Generalized Anxiety Disorder Scale (GAD-7) Score
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Shape Trail Test (STT) Part A and Part B Completion Time
Time frame: Change from baseline to end of intervention, up to 12 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Change from baseline to end of intervention, up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Baichao Xu, PhD study director
Hainan Medical College
Ziheng Ning, PhD study director
Macao Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Exercise and Health Education in people with Aging and Postural Balance, run by Zhide Liang.
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Jul 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhide Liang, MS (0853-65597656, p2516238@mpu.edu.mo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Berg Balance Scale (BBS) Score (time frame: Change from baseline to end of intervention, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.