Adhesive CapsulitisPIT; ACNCT07134010
The Impact of Perineural Injection Therapy for Adhesive Capsulitis.
A study testing perineural injection and Physiotherapy in people with Adhesive Capsulitis, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to learn if Perineural Injection Therapy (PIT) works to treat adhesive capsulitis (frozen shoulder) in adults. It will also learn about the safety of PIT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- perineural injection and Physiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Jun 2025to 1 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above.
- Diagnosed with primary adhesive capsulitis by a specialist.
- Limitation of range of motion ≥ 50% relative to the normal side or normal reference (in patient with bilateral adhesive capsulitis) in three or more movement directions (i.e., external rotation, abduction, forward flexion, and internal rotation).
- Chronic adhesive capsulitis shoulder pain lasting for at least 3 months.
- Pain score of at least 4/10 on the Numerical Rating Scale (NRS) during movement, indicating at least moderate pain severity.
- Consented to the study.
Who cannot join
- Received any shoulder pain injection within the past 6 weeks or surgical intervention such manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
- Diagnosed with other shoulder pathology such as neurologic deficits affecting shoulder function, tumour, rotator cuff injury or fracture.
- Has history of allergy to dextrose solution.
- Patients receiving steroidsimmunosuppressants, psychotropic medication, or other medications that may affect, the clinical outcomes
- Patients with haemorrhagic disease, taking anticoagulant drugs, or patients with severe diabetes mellitus having an increased risk of infection (HBA1c >8%)
- Do not understand Malay or English language.
- Unable to follow a 3 steps command.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Al-Sultan Abdullah, UiTM Puncak Alam
Kuala Selangor, Selangor, 42300
Noor Hafizah Samsudin Bahari, MD(UKM), +60333963395, 2023204074@student.uitm.edu.my
Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehab(UM), +60333963395, aniefarhana@uitm.edu.my
About this study
Official title: The Impact of Perineural Injection Therapy for Adhesive Capsulitis at a Single Centre University Hospital in Selangor: A Pilot Study
The goal of this clinical trial is to learn if Perineural Injection Therapy (PIT) works to treat adhesive capsulitis (frozen shoulder) in adults. It will also learn about the safety of PIT.
The main questions it aims to answer are:
Read more
Does PIT reduce shoulder pain and improve shoulder range of motion more effectively than conventional therapy alone?
What side effects or medical problems do participants experience when receiving PIT?
Researchers will compare PIT to conventional therapy to see if PIT works better to treat adhesive capsulitis.
Participants will:
Receive either:
PIT once weekly for 6 weeks plus physiotherapy and oral analgesics (excluding NSAIDs), or
Conventional therapy only (physiotherapy and analgesics including NSAIDs)
Attend scheduled follow-up visits at Week 6, 1 month, and 3 months after treatment
Perform daily home-based shoulder exercises and record their analgesic use and any side effects in a patient diary
Read the detailed description
Study Title:
The Impacts of Perineural Injection Therapy on Adhesive Capsulitis in a Single Centre Hospital in Selangor: A Randomized Controlled Trial Pilot Study
Study Overview :
Adhesive capsulitis, commonly known as "frozen shoulder," is a painful condition that limits shoulder movement and affects daily activities such as dressing, reaching overhead, or lifting objects. It often affects adults between the ages of 40 to 60 and can last for months or even years. For some, the condition may improve with physiotherapy and medication, but others continue to struggle with pain and stiffness.
This clinical trial aims to explore a new method of treatment called Perineural Injection Therapy (PIT). PIT involves injecting a natural sugar solution (5% dextrose) just under the skin at specific nerve areas around the shoulder. This method targets nerves that may be irritated or inflamed and helps to reduce pain and improve movement.
Although PIT has shown promising results in treating other painful conditions like nerve entrapments and joint pain, its effects on frozen shoulder have not yet been well studied. This research hopes to find out if PIT can help relieve pain, improve shoulder movement, and enhance function in people with frozen shoulder.
The current treatment options for frozen shoulder (such as physiotherapy, painkillers, and steroid injections) do not work for everyone. PIT is a non-surgical option that may help the healing process by calming nerve-related inflammation. This study will evaluate how effective PIT is and whether it is safe for use in treating adhesive capsulitis.
Participants will be randomly assigned to one of two groups:
Intervention Group: Will receive six weekly sessions of PIT combined with physiotherapy and oral pain medication (excluding NSAIDs like ibuprofen).
Control Group: Will receive only conventional therapy, including physiotherapy and standard painkillers (including NSAIDs).
All participants will:
Be evaluated for shoulder pain, range of motion, and ability to perform daily activities at the beginning of the study, at Week 6, 1-month, and 3-months after treatment.
Be taught home exercises to do daily to improve shoulder mobility and strength.
Be asked to keep a diary to record medication use and any side effects they experience.
Receive support and regular follow-ups from the research team to monitor progress and manage any issues.
Adults aged 18 and above who have been diagnosed with primary (idiopathic) adhesive capsulitis for at least 3 months and are experiencing significant shoulder pain and stiffness may be eligible. Participants must be able to understand and follow instructions in Malay or English.
People will not be eligible if they:
Have had a shoulder injection or surgery recently
Have other serious shoulder problems (like a fracture or nerve injury)
Have poorly controlled diabetes or are on certain medications that may interfere with the study
PIT is generally safe and has been used in other conditions with minimal side effects, such as mild pain or redness at the injection site. In this study, participants will be closely monitored for any adverse effects.
Potential benefits include reduced pain, improved shoulder movement, and better overall function. The information gathered may help develop better treatment options for others with frozen shoulder in the future.
Each participant will be involved in the study for approximately 3 to 4 months, including the 6-week treatment period and two follow-up assessments.
- Conditions
- Adhesive Capsulitis
- Being tested
- perineural injection, Physiotherapy
- Keywords
- Perineural injection therapy in treating Adhesive Capsulitis
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural injectionOther
Also called Perineural injection therapy, PIT
Intervention The procedure will be performed by a rehabilitation physician who has obtained hospital-level credentialing and privileging to practice Perineural Injection Therapy (PIT). The physician has undergone hands-on training with Dr. Lyftogt-certified trainers in Malaysia.
PIT will be administered weekly for six week (Total 6 sessions). In addition to this intervention, patient will also receive conventional therapy which is monthly outpatient physiotherapy with supplementary home-based exercise program, and oral analgesia (except NSAIDs).
Solution: Buffered 5% dextrose.
Pre injection: Chronic constriction injury points will be identified by palpation along the shoulder's cutaneous nerves - the suprascapular, supraclavicular, axillary, musculocutaneous, and radial nerves. These points will be marked to ensure precise targeting. Taking into account these nerve pathways, the maximum injection area for this research is set at 10 sites per session.
PhysiotherapyOther
Patients will be receiving a structured home-based exercise program and will be instructed on how to perform these exercises at home. The exercise regime will be 30 minutes, 3 times a day to enhance shoulder mobility and strength in addition to the regular monthly outpatient physiotherapy session. Oral analgesics exclude NSAIDs will be prescribed as needed to manage pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Perineural injection Therapy Receives: Other: perineural injection; Other: Physiotherapy |
| Conventional group | Sham comparator | Physiotherapy Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Participants will rate their shoulder pain on a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain."
Measured: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Shoulder Range of Motion (ROM)
Tool: Goniometer (standardized physical measurement)
Passive ROM will be measured in four directions: forward flexion, abduction, internal rotation, and external rotation. Values will be recorded in degrees.
Measured: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Secondary outcomes (2)
Functional Outcome
Tool: Shoulder Pain and Disability Index (SPADI) - validated English and Malay versions
A self-reported questionnaire with 13 items divided into two subscales: 5 for pain and 8 for functional disability. Each item is scored from 0 (no pain/disability) to 10 (worst pain/disability), with higher scores indicating greater impairment.
Measured: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Adverse Reactions
Tool: Adverse Event Reporting Form and Patient Diary
Description: Side effects will be classified into:
Mild: Local pain, bruising, or redness
Moderate: Transient numbness, swelling, or prolonged discomfort
Severe: Infection or allergic reaction
Measured: Monitored throughout the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start3 Jun 2025
- Primary completion31 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, single-center, two-arm, parallel-group, randomized controlled pilot trial conducted to assess the impact of Perineural Injection Therapy (PIT) on pain, shoulder mobility, and function in patients with adhesive capsulitis. Participants will be randomly assigned in a 1:1 ratio to either: Intervention Group: PIT plus conventional therapy (physiotherapy and analgesics excluding NSAIDs) Control Group: Conventional therapy alone (physiotherapy and analgesics including NSAIDs) Randomization will be implemented using a computer-generated random sequence prepared in advance and managed by an independent staff nurse not involved in treatment or outcome assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. Due to the procedural nature of PIT, blinding is not feasible for participants and treating physicians. However, outcome assessors (physiotherapists) will be blinded to group assignments to reduce bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Hafizah Binti Samsudin Bahari, Universiti Teknologi Mara
- Investigators
- Noor Hafizah Samsudin Bahari, MD(UKM), Principal investigator, Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh CampusDr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehabMed(UM), Principal investigator, Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh CampusAssoc. Prof. Dr. Nadia Mohd Mustafah, MD(UPM), MRehabMed(UM), Principal investigator, Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134010
- Sponsor's protocol ID
- REC/06/2025 (PG/FB/26)
- Acronym
- PIT; AC
- Status last verified
- Jun 2025
- First submitted
- 14 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perineural Injection Therapy for Adhesive Capsulitis at a Single Centre University Hospital in Selangor: A Pilot Study
- ClinicalTrials.gov ID
- NCT07134010
- Acronym / sponsor ID
- PIT; AC / REC/06/2025 (PG/FB/26)
- Conditions
- Adhesive Capsulitis
- Keywords
- Perineural injection therapy in treating Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Perineural Injection Therapy (PIT) works to treat adhesive capsulitis (frozen shoulder) in adults. It will also learn about the safety of PIT.
The main questions it aims to answer are:
Does PIT reduce shoulder pain and improve shoulder range of motion more effectively than conventional therapy alone?
What side effects or medical problems do participants experience when receiving PIT?
Researchers will compare PIT to conventional therapy to see if PIT works better to treat adhesive capsulitis.
Participants will:
Receive either:
PIT once weekly for 6 weeks plus physiotherapy and oral analgesics (excluding NSAIDs), or
Conventional therapy only (physiotherapy and analgesics including NSAIDs)
Attend scheduled follow-up visits at Week 6, 1 month, and 3 months after treatment
Perform daily home-based shoulder exercises and record their analgesic use and any side effects in a patient diary
Detailed description
Study Title:
The Impacts of Perineural Injection Therapy on Adhesive Capsulitis in a Single Centre Hospital in Selangor: A Randomized Controlled Trial Pilot Study
Study Overview :
Adhesive capsulitis, commonly known as "frozen shoulder," is a painful condition that limits shoulder movement and affects daily activities such as dressing, reaching overhead, or lifting objects. It often affects adults between the ages of 40 to 60 and can last for months or even years. For some, the condition may improve with physiotherapy and medication, but others continue to struggle with pain and stiffness.
This clinical trial aims to explore a new method of treatment called Perineural Injection Therapy (PIT). PIT involves injecting a natural sugar solution (5% dextrose) just under the skin at specific nerve areas around the shoulder. This method targets nerves that may be irritated or inflamed and helps to reduce pain and improve movement.
Although PIT has shown promising results in treating other painful conditions like nerve entrapments and joint pain, its effects on frozen shoulder have not yet been well studied. This research hopes to find out if PIT can help relieve pain, improve shoulder movement, and enhance function in people with frozen shoulder.
The current treatment options for frozen shoulder (such as physiotherapy, painkillers, and steroid injections) do not work for everyone. PIT is a non-surgical option that may help the healing process by calming nerve-related inflammation. This study will evaluate how effective PIT is and whether it is safe for use in treating adhesive capsulitis.
Participants will be randomly assigned to one of two groups:
Intervention Group: Will receive six weekly sessions of PIT combined with physiotherapy and oral pain medication (excluding NSAIDs like ibuprofen).
Control Group: Will receive only conventional therapy, including physiotherapy and standard painkillers (including NSAIDs).
All participants will:
Be evaluated for shoulder pain, range of motion, and ability to perform daily activities at the beginning of the study, at Week 6, 1-month, and 3-months after treatment.
Be taught home exercises to do daily to improve shoulder mobility and strength.
Be asked to keep a diary to record medication use and any side effects they experience.
Receive support and regular follow-ups from the research team to monitor progress and manage any issues.
Adults aged 18 and above who have been diagnosed with primary (idiopathic) adhesive capsulitis for at least 3 months and are experiencing significant shoulder pain and stiffness may be eligible. Participants must be able to understand and follow instructions in Malay or English.
People will not be eligible if they:
Have had a shoulder injection or surgery recently
Have other serious shoulder problems (like a fracture or nerve injury)
Have poorly controlled diabetes or are on certain medications that may interfere with the study
PIT is generally safe and has been used in other conditions with minimal side effects, such as mild pain or redness at the injection site. In this study, participants will be closely monitored for any adverse effects.
Potential benefits include reduced pain, improved shoulder movement, and better overall function. The information gathered may help develop better treatment options for others with frozen shoulder in the future.
Each participant will be involved in the study for approximately 3 to 4 months, including the 6-week treatment period and two follow-up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, single-center, two-arm, parallel-group, randomized controlled pilot trial conducted to assess the impact of Perineural Injection Therapy (PIT) on pain, shoulder mobility, and function in patients with adhesive capsulitis. Participants will be randomly assigned in a 1:1 ratio to either: Intervention Group: PIT plus conventional therapy (physiotherapy and analgesics excluding NSAIDs) Control Group: Conventional therapy alone (physiotherapy and analgesics including NSAIDs) Randomization will be implemented using a computer-generated random sequence prepared in advance and managed by an independent staff nurse not involved in treatment or outcome assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. Due to the procedural nature of PIT, blinding is not feasible for participants and treating physicians. However, outcome assessors (physiotherapists) will be blinded to group assignments to reduce bias.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: perineural injection, Other: PhysiotherapyPerineural injection Therapy |
| Conventional group | Sham comparator | Other: PhysiotherapyPhysiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 and above.
- Diagnosed with primary adhesive capsulitis by a specialist.
- Limitation of range of motion ≥ 50% relative to the normal side or normal reference (in patient with bilateral adhesive capsulitis) in three or more movement directions (i.e., external rotation, abduction, forward flexion, and internal rotation).
- Chronic adhesive capsulitis shoulder pain lasting for at least 3 months.
- Pain score of at least 4/10 on the Numerical Rating Scale (NRS) during movement, indicating at least moderate pain severity.
Key exclusion criteria (7 listed)
- Received any shoulder pain injection within the past 6 weeks or surgical intervention such manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
- Diagnosed with other shoulder pathology such as neurologic deficits affecting shoulder function, tumour, rotator cuff injury or fracture.
- Has history of allergy to dextrose solution.
- Patients receiving steroidsimmunosuppressants, psychotropic medication, or other medications that may affect, the clinical outcomes
- Patients with haemorrhagic disease, taking anticoagulant drugs, or patients with severe diabetes mellitus having an increased risk of infection (HBA1c >8%)
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 |
|---|---|---|
| perineural injectionAlso: Perineural injection therapy, PITIntervention The procedure will be performed by a rehabilitation physician who has obtained hospital-level credentialing and privileging to practice Perineural Injection Therapy (PIT). The physician has undergone hands-on training with Dr. Lyftogt-certified trainers in Malaysia. PIT will be administered weekly for six week (Total 6 sessions). In addition to this intervention, patient will also receive conventional therapy which is monthly outpatient physiotherapy with supplementary home-based exercise program, and oral analgesia (except NSAIDs). Solution: Buffered 5% dextrose. Pre injection: Chronic constriction injury points will be identified by palpation along the shoulder's cutaneous nerves - the suprascapular, supraclavicular, axillary, musculocutaneous, and radial nerves. These points will be marked to ensure precise targeting. Taking into account these nerve pathways, the maximum injection area for this research is set at 10 sites per session. | Other | Intervention group |
| PhysiotherapyPatients will be receiving a structured home-based exercise program and will be instructed on how to perform these exercises at home. The exercise regime will be 30 minutes, 3 times a day to enhance shoulder mobility and strength in addition to the regular monthly outpatient physiotherapy session. Oral analgesics exclude NSAIDs will be prescribed as needed to manage pain. | Other | Conventional group, Intervention group |
Primary outcome
Numerical Rating Scale
Time frame: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Participants will rate their shoulder pain on a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain."
Shoulder Range of Motion (ROM)
Time frame: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Tool: Goniometer (standardized physical measurement) Passive ROM will be measured in four directions: forward flexion, abduction, internal rotation, and external rotation. Values will be recorded in degrees.
2 secondary outcomes
Functional Outcome
Time frame: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Adverse Reactions
Time frame: Monitored throughout the 6-week intervention
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 4 Sep 2025.
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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.
Noor Hafizah Samsudin Bahari, MD(UKM) principal investigator
Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus
Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehabMed(UM) principal investigator
Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus
Assoc. Prof. Dr. Nadia Mohd Mustafah, MD(UPM), MRehabMed(UM) principal investigator
Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perineural injection and Physiotherapy in people with Adhesive Capsulitis, run by Universiti Teknologi Mara at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 Malaysia. 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?
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 Noor Hafizah Samsudin Bahari, MD(UKM) (+60333963395, 2023204074@student.uitm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (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?
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 4 Sep 2025.