Vertigo, ParoxysmalNCT04469309
Comparison of Half-Somersault Exercise With Brandt-Daroff Exercise in BPPV.
A study testing Group I Brandt-Daroff Exercises and Group II Half-Somersault Maneuver in people with Vertigo, Paroxysmal, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is important as there are numbers of BPPV patients presenting to outpatient departments which needs more efficient techniques for management of BPPV. Talking about literature, there are numbers of studies done on different maneuvers but there is yet no study available which compares these maneuvers. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Vertigo, Paroxysmal
- What is being tested?
- Group I Brandt-Daroff Exercises and Group II Half-Somersault Maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2020to 31 Oct 2020
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed Patients with PC-BPPV
- Age group 25-50 years.
- DHI Scale: 36-42 (moderate handicap)
- Both gender
- Duration of complaints: from the past 6 months
Who cannot join
- Migraine related dizziness and Anxiety disorder
- Other vestibular conditions are: Acoustic neuroma, Labyrinthitis, Vestibular hypo function, Meniere's disease.
- Any cervical pathology,
- CNS Pathology causing dizziness and vertigo
- Other pathologies which may affect balance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Half-Somersault Exercise With Brandt-Daroff Exercise in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial
This study is important as there are numbers of BPPV patients presenting to outpatient departments which needs more efficient techniques for management of BPPV. Talking about literature, there are numbers of studies done on different maneuvers but there is yet no study available which compares these maneuvers. So the purpose of this study is to compare these techniques to find which one is more effective in treating PC-BPPV.
Read the detailed description
Benign paroxysmal positional vertigo (BPPV) is one of the most common causes in patients with vestibular disorders .BPPV has often been described as "self-limiting" because symptoms often subside or disappear within six months of onset . BPPV may be characterized by sudden changes in the position of the head, such as lying down on one or both sides, looking right or left side . Vertigo is defined as illusion of movement which could be spinning, rocking, tilting or dropping . Benign paroxysmal positional vertigo (BPPV) is the most frequent vestibular disorder and the leading cause of vertigo in adults.BPPV may be divided into 3 types based on canal involvement i.e Posterior, Horizontal, and Anterior Semicircular Canal BPPV. BPPV clinical findings agree with the hypothesis that semicircular canals with greater incidence is posterior canal, have floating particles or debris, which are heavier than the circulating endolymph . The vestibular system is located in the inner ear and consists of the utricle, saccule and three semicircular canals (i.e. posterior, anterior and horizontal). These canals react to rotational movements of the head . Of the types of BPPV, posterior semicircular canal BPPV (PC-BPPV) is the most common form, accounting for 85 to 90% of cases Lateral Canal BPPV is about 20%, and Anterior Canal BPPV is very rare as it is self-treated due to gravity . BPPV accounts for 8% of the subjects with moderate or severe dizziness/vertigo. It may be present in child hood but increases with age. The lifetime prevalence is estimated to be 2%. It´s reported that the oneyear prevalence is 0.5% in 18-39 years old and 3.4% in people over 60-years of age . Benign paroxysmal positional vertigo (BPPV) is the paroxysmal transient vertigo caused by specific changes in head position, accounting for 60% of peripheral vertigo, with an incidence rate of approximately 64/10000 . The average recurrence rate is around 50%. BPPV is more common in women than men; and the ratio of women to man population is 2:1.BPPV can be caused either by canalithiasis or by cupulolithiasis. Movement of the head causes these otoliths to inappropriately trigger the receptors in the semicircular canals and send false signals to the brain, causing vertigo and nystagmus . Factors that can be helpful in guiding the clinician in the evaluation of the patient with dizziness include the characteristics of the dizziness; associated symptoms (ie, hearing loss or tinnitus) duration of symptoms; and what, if anything, triggered the symptoms (precipitating factors) . Posterior canal BPPV is treated using canalith repositioning procedures, the most common of which is the Epley maneuver(EM) , half somersault exercises , Brandt Daroff exercise , Semont maneuver, vestibular habituation exercises, balance and eye exercises . Dix-Hallpike test is used to diagnose BPPV patients . Paramasivan Mani et al suggested in their study that half somersault exercise with Brandt Daroff exercise for 3 weeks showed significantly greater improvement in reducing self-perceived handicap among Patients with Posterior Canal Benign Paroxysmal Positional Vertigo . Ashok Kumar Gupta et.al concluded that Epley maneuver has produced maximum improvement than Semont maneuver and least improvement was produced by Brandt-Daroff Exercises . Herman Guild Manayil John et al observed in their study that Epley's manoeuvre to be a simple, useful and cost-effective treatment for BPPV . Nevzat Demirbilek, conducted a study of Combined Epley and Semont Maneuver in Benign Paroxysmal Positional Vertigo and concluded that, the combined maneuvers in our study were found to have an increased success rate . Devangi S. Desai et al concluded that, both Epley's maneuver and Brandt-daroff treatment approaches are effective in reducing symptoms and improving independence level but combined approaches can give better results so modified epley'smaneuver should be applied 3 times in one session along with brandt- daroff exercise as home exercise .
- Conditions
- Vertigo, Paroxysmal
- Being tested
- Group I Brandt-Daroff Exercises, Group II Half-Somersault Maneuver
- Keywords
- Half-Somersault Exercise, Brandt-Daroff exercise, Posterior Canal, Benign Paroxysmal Positional Vertigo
- Medical subject headings
- Vertigo, Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I Brandt-Daroff ExercisesOther
In group I Brandoff Exercises will be performed using standard method, in which the patient is in the sitting position on examination table, the patient moves into the lying position on the affected side on the shoulder, with the head angled upward with about 45. The patient stays in this for 30 s and then goes back to the sitting position, looks forward and remains in this position for 30 s as well. The patient repeats the same procedure for the other side, too.
The patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. Pre, mid and post assessment.
Group II Half-Somersault ManeuverOther
In group II Half-Somersault Maneuver will be done, the patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I will receive Brandoff Exercises Receives: Other: Group I Brandt-Daroff Exercises |
| Group II | Active comparator | Group II will receive Somersault exercises Receives: Other: Group II Half-Somersault Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular activities and participation measure
The Vestibular Activities and Participation Measure (VAP) is a 34-item self-report questionnaire that asks the individual to evaluate the effect of dizziness and/or balance problems on their ability to perform activity and participation tasks.The response range from none (0 points) ,moderate (2 points), severe (3 points) unable to do (4 points) to not applicable. The total score is obtained after calculating the average of the item scale values and excluding the not applicable item scale scores
Measured: Change from Baseline dizziness and balance to 2 Weeks
Dix-Hall pike test
Dix-Hall pike is the standard procedure for diagnosis of PC-BPPV. The Dix-Hallpike Test (DHT) is considered the gold standard assessment for the diagnosis of the vestibular disorder Benign Paroxysmal Positional Vertigo (BPPV). The Dix-Hallpike test involves rapidly moving the patient from a sitting position to "head hanging," where the patient's head is at least 10 degrees below horizontal.
Measured: Change from Baseline dizziness to 2 Week
Secondary outcomes (1)
Fall efficacy scale (FES)
Fall efficacy scale (FES) scale is a measure used to quantify an individual's concern of falling during different tasks. The FES is a reliable and valid tool for measuring an individual's concern of falling in a sample of people with vestibular disorders. It consists of 10 activities which are asked from patients.On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, A total score of greater than 70 indicates that the person has a fear of falling.
Measured: Change from Baseline dizziness to 2 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Jun 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vertigo, ParoxysmalStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469309
- Sponsor's protocol ID
- REC/00744 M Jaffar
- Status last verified
- Mar 2021
- First submitted
- 14 Apr 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta AK, Sharma KG, Sharma P. Effect of Epley, Semont Maneuvers and Brandt-Daroff Exercise on Quality of Life in Patients with Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (PSCBPPV). Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):99-103. doi: 10.1007/s12070-018-1322-7. Epub 2018 Mar 30.
PubMed 30906723Maranhao ET, Whitney SL, Maranhao-Filho P. Tumarkin-like phenomenon as a sign of therapeutic success in benign paroxysmal positional vertigo. Arq Neuropsiquiatr. 2018 Aug;76(8):534-538. doi: 10.1590/0004-282X20180073.
PubMed 30231127Beeumen N Van. Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie. 2018
Zhang YX, Wu CL, Zhong FF, Ding CN. Evaluation of efficacies and recurrence rates of three self-treatment maneuvers for posterior semicircular canal benign paroxysmal positional vertigo. Int J Clin Exp Med. 2016;9(6):11780-7
Kinne BL. Benign paroxysmal positional vertigo. Eye Mov Disord (Nystagmus Strabismus) Diagnosis, Manag Impact Qual Life. 2014;9(1):1-30.
Desai DS, Chauhan AS, Trivedi MN. Role of Modified Epley'S Maneuver and Brandt-Daroff Exercises in Treatment of Posterior Canal Bppv: a Comparative Study. Int J Physiother Res. 2015;3(3):1059-64.
Manayil John HG, John A. Efficacy of Epley'S Manoeuvre in Posterior Canal Benign Paroxysmal Positional Vertigo. J Evid Based Med Healthc. 2016;3(102):5624-7.
Jaffar M, Ghous M, Ayaz M, Khan AA, Akbar A, Haleem F. Effects of Half-Somersault and Brandt-Daroff exercise on dizziness, fear of fall and quality of life in patients with posterior canal benign paroxysmal positional vertigo: A randomised control trial. J Pak Med Assoc. 2023 Jan;73(1):139-142. doi: 10.47391/JPMA.3333.
PubMed 36842024
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Half-Somersault Exercise With Brandt-Daroff Exercise in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04469309
- Acronym / sponsor ID
- REC/00744 M Jaffar
- Conditions
- Vertigo, Paroxysmal
- Keywords
- Half-Somersault Exercise, Brandt-Daroff exercise, Posterior Canal, Benign Paroxysmal Positional Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 14 Jul 2020 (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 important as there are numbers of BPPV patients presenting to outpatient departments which needs more efficient techniques for management of BPPV. Talking about literature, there are numbers of studies done on different maneuvers but there is yet no study available which compares these maneuvers. So the purpose of this study is to compare these techniques to find which one is more effective in treating PC-BPPV.
Detailed description
Benign paroxysmal positional vertigo (BPPV) is one of the most common causes in patients with vestibular disorders .BPPV has often been described as "self-limiting" because symptoms often subside or disappear within six months of onset . BPPV may be characterized by sudden changes in the position of the head, such as lying down on one or both sides, looking right or left side . Vertigo is defined as illusion of movement which could be spinning, rocking, tilting or dropping . Benign paroxysmal positional vertigo (BPPV) is the most frequent vestibular disorder and the leading cause of vertigo in adults.BPPV may be divided into 3 types based on canal involvement i.e Posterior, Horizontal, and Anterior Semicircular Canal BPPV. BPPV clinical findings agree with the hypothesis that semicircular canals with greater incidence is posterior canal, have floating particles or debris, which are heavier than the circulating endolymph . The vestibular system is located in the inner ear and consists of the utricle, saccule and three semicircular canals (i.e. posterior, anterior and horizontal). These canals react to rotational movements of the head . Of the types of BPPV, posterior semicircular canal BPPV (PC-BPPV) is the most common form, accounting for 85 to 90% of cases Lateral Canal BPPV is about 20%, and Anterior Canal BPPV is very rare as it is self-treated due to gravity . BPPV accounts for 8% of the subjects with moderate or severe dizziness/vertigo. It may be present in child hood but increases with age. The lifetime prevalence is estimated to be 2%. It´s reported that the oneyear prevalence is 0.5% in 18-39 years old and 3.4% in people over 60-years of age . Benign paroxysmal positional vertigo (BPPV) is the paroxysmal transient vertigo caused by specific changes in head position, accounting for 60% of peripheral vertigo, with an incidence rate of approximately 64/10000 . The average recurrence rate is around 50%. BPPV is more common in women than men; and the ratio of women to man population is 2:1.BPPV can be caused either by canalithiasis or by cupulolithiasis. Movement of the head causes these otoliths to inappropriately trigger the receptors in the semicircular canals and send false signals to the brain, causing vertigo and nystagmus . Factors that can be helpful in guiding the clinician in the evaluation of the patient with dizziness include the characteristics of the dizziness; associated symptoms (ie, hearing loss or tinnitus) duration of symptoms; and what, if anything, triggered the symptoms (precipitating factors) . Posterior canal BPPV is treated using canalith repositioning procedures, the most common of which is the Epley maneuver(EM) , half somersault exercises , Brandt Daroff exercise , Semont maneuver, vestibular habituation exercises, balance and eye exercises . Dix-Hallpike test is used to diagnose BPPV patients . Paramasivan Mani et al suggested in their study that half somersault exercise with Brandt Daroff exercise for 3 weeks showed significantly greater improvement in reducing self-perceived handicap among Patients with Posterior Canal Benign Paroxysmal Positional Vertigo . Ashok Kumar Gupta et.al concluded that Epley maneuver has produced maximum improvement than Semont maneuver and least improvement was produced by Brandt-Daroff Exercises . Herman Guild Manayil John et al observed in their study that Epley's manoeuvre to be a simple, useful and cost-effective treatment for BPPV . Nevzat Demirbilek, conducted a study of Combined Epley and Semont Maneuver in Benign Paroxysmal Positional Vertigo and concluded that, the combined maneuvers in our study were found to have an increased success rate . Devangi S. Desai et al concluded that, both Epley's maneuver and Brandt-daroff treatment approaches are effective in reducing symptoms and improving independence level but combined approaches can give better results so modified epley'smaneuver should be applied 3 times in one session along with brandt- daroff exercise as home exercise .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Group I Brandt-Daroff ExercisesGroup I will receive Brandoff Exercises |
| Group II | Active comparator | Other: Group II Half-Somersault ManeuverGroup II will receive Somersault exercises |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed Patients with PC-BPPV
- Age group 25-50 years.
- DHI Scale: 36-42 (moderate handicap)
- Both gender
- Duration of complaints: from the past 6 months
Key exclusion criteria (5 listed)
- Migraine related dizziness and Anxiety disorder
- Other vestibular conditions are: Acoustic neuroma, Labyrinthitis, Vestibular hypo function, Meniere's disease.
- Any cervical pathology,
- CNS Pathology causing dizziness and vertigo
- Other pathologies which may affect balance.
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 |
|---|---|---|
| Group I Brandt-Daroff ExercisesIn group I Brandoff Exercises will be performed using standard method, in which the patient is in the sitting position on examination table, the patient moves into the lying position on the affected side on the shoulder, with the head angled upward with about 45. The patient stays in this for 30 s and then goes back to the sitting position, looks forward and remains in this position for 30 s as well. The patient repeats the same procedure for the other side, too. The patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. Pre, mid and post assessment. | Other | Group I |
| Group II Half-Somersault ManeuverIn group II Half-Somersault Maneuver will be done, the patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. | Other | Group II |
Primary outcome
Vestibular activities and participation measure
Time frame: Change from Baseline dizziness and balance to 2 Weeks
The Vestibular Activities and Participation Measure (VAP) is a 34-item self-report questionnaire that asks the individual to evaluate the effect of dizziness and/or balance problems on their ability to perform activity and participation tasks.The response range from none (0 points) ,moderate (2 points), severe (3 points) unable to do (4 points) to not applicable. The total score is obtained after calculating the average of the item scale values and excluding the not applicable item scale scores
Dix-Hall pike test
Time frame: Change from Baseline dizziness to 2 Week
Dix-Hall pike is the standard procedure for diagnosis of PC-BPPV. The Dix-Hallpike Test (DHT) is considered the gold standard assessment for the diagnosis of the vestibular disorder Benign Paroxysmal Positional Vertigo (BPPV). The Dix-Hallpike test involves rapidly moving the patient from a sitting position to "head hanging," where the patient's head is at least 10 degrees below horizontal.
1 secondary outcome
Fall efficacy scale (FES)
Time frame: Change from Baseline dizziness to 2 Week
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 9 Mar 2021.
- Background: PubMed 30906723Gupta AK, Sharma KG, Sharma P. Effect of Epley, Semont Maneuvers and Brandt-Daroff Exercise on Quality of Life in Patients with Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (PSCBPPV). Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):99-103. doi: 10.1007/s12070-018-1322-7. Epub 2018 Mar 30.
- Background: PubMed 30231127Maranhao ET, Whitney SL, Maranhao-Filho P. Tumarkin-like phenomenon as a sign of therapeutic success in benign paroxysmal positional vertigo. Arq Neuropsiquiatr. 2018 Aug;76(8):534-538. doi: 10.1590/0004-282X20180073.
- BackgroundBeeumen N Van. Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie. 2018
- BackgroundZhang YX, Wu CL, Zhong FF, Ding CN. Evaluation of efficacies and recurrence rates of three self-treatment maneuvers for posterior semicircular canal benign paroxysmal positional vertigo. Int J Clin Exp Med. 2016;9(6):11780-7
- BackgroundKinne BL. Benign paroxysmal positional vertigo. Eye Mov Disord (Nystagmus Strabismus) Diagnosis, Manag Impact Qual Life. 2014;9(1):1-30.
- BackgroundDesai DS, Chauhan AS, Trivedi MN. Role of Modified Epley'S Maneuver and Brandt-Daroff Exercises in Treatment of Posterior Canal Bppv: a Comparative Study. Int J Physiother Res. 2015;3(3):1059-64.
- BackgroundManayil John HG, John A. Efficacy of Epley'S Manoeuvre in Posterior Canal Benign Paroxysmal Positional Vertigo. J Evid Based Med Healthc. 2016;3(102):5624-7.
- Derived from this study: PubMed 36842024Jaffar M, Ghous M, Ayaz M, Khan AA, Akbar A, Haleem F. Effects of Half-Somersault and Brandt-Daroff exercise on dizziness, fear of fall and quality of life in patients with posterior canal benign paroxysmal positional vertigo: A randomised control trial. J Pak Med Assoc. 2023 Jan;73(1):139-142. doi: 10.47391/JPMA.3333.
- 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.
Misbah Ghous, MSNMPT principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I Brandt-Daroff Exercises and Group II Half-Somersault Maneuver in people with Vertigo, Paroxysmal, run by Riphah International University at 1 site in Pakistan.
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 5 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: finished, as of the sponsor's last update on 9 Mar 2021. 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 Pakistan. 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?
Vestibular activities and participation measure (time frame: Change from Baseline dizziness and balance to 2 Weeks). 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 NCT04469309, which also lists 8 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 9 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.