Osteoarthritis, KneeNCT05869630
Exercise on microRNA in Osteoarthritis
A study testing Exercise Programme and Experiments in people with Osteoarthritis, Knee and Epigenetic Disorder, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The present study is a prospective cohort study. This study will be conducted to determine the change in miRNA levels with exercise in knee Osteoarthritis (OA) patients. The main questions that the study aims to answer are: Question 1: Does exercise therapy affect microrna expressions in patients with knee… Read more about this study
- Who is it for?
- Ages 38 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Epigenetic Disorder, Quality of Life
- What is being tested?
- Exercise Programme and Experiments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 17 Jun 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 38 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having Kellgren-Lawrence grade 2 or grade 3 knee OA
- Body mass index (BMI) between 20-35.
Who cannot join
- Rheumatoid Arthritis,
- Having knee replacement surgery,
- Intra-articular injection in the last six months,
- Usage of opioid analgesics or corticosteroids,
- Being under severe pain (VAS>7),
- Pregnancy,
- Having cardiovascular disease,
- Stroke and chronic obstructive pulmonary disease (COPD).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Hospital Research Hospital, Physical Medicine and Rehabilitation
Istanbul
About this study
Official title: Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Knee Osteoarthritis
The present study is a prospective cohort study. This study will be conducted to determine the change in miRNA levels with exercise in knee Osteoarthritis (OA) patients. The main questions that the study aims to answer are:
Question 1: Does exercise therapy affect microrna expressions in patients with knee osteoarthritis?
Read more
Question 2: Does exercise therapy affect quality of life, pain, functional status and depression level in patients with knee osteoarthritis?
Participants; demographic information such as age, height, weight will be questioned. Exercises will performed twice a week under supervision and once a week as home program for eight weeks. Before and after exercise treatment, peripheral venous blood samples will taken from both groups. miRNA-146a, miRNA-155, miRNA-221-3p and miRNA-145 gene expressions will studied with the real-time PCR (polymerase chain reaction) method. miRNA-146a, miRNA-155, and miRNA-221-3p, miRNA-145 gene expressions will studied with the Real-time PCR method. The pain will evaluated with the Numeric Rating Scale (NRS), functional status with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), depression level with the Beck Depression Inventory (BDI), and quality of life with Short Form-36 (SF-36).
Read the detailed description
Osteoarthritis is a degenerative disease causing joint pain, stiffness, and limitation of motion with loss of cartilage, osteophyte development, subchondral sclerosis, changes in the joint capsule and synovial membrane as a result of the disruption of genetic, biomechanical, and biochemical balances. Pharmacological treatments of osteoarthritis include simple analgesics, non-steroidal anti-inflammatory drugs, opioids and topical analgesics. Patient education, self-management programs, exercise, weight loss, assistive devices and lifestyle changes are non-pharmacological treatment methods.Exercise is one of the basic elements of the treatment modality. The purpose of the exercise; to relieve symptoms and improve muscle strength around joints. It is aimed to increase the quality of life with the adaptation of individuals to exercise.
miRNA, one of the small non-coding RNA subunits, is responsible for the modulation of protein-coding genes as a result of post-transcriptional repression. miRNA play an active role in many biological events such as cellular differentiation, apoptosis, proliferation, erythropoiesis, fibrosis and angiogenesis. Due to the role of miRNAs in normal development and diseases, it is thought that they will be a new biomarker for therapeutic purposes in the future. It was found that miRNAs play a key role in physiological conditions e.g. skeletal muscle hypertrophy, mitochondrial biogenesis, vascular angiogenesis, and metabolic events when combined with exercise. The identification of miRNAs that change in circulation with exercise is important in terms of providing new data on the physiological adaptation of exercise. In recent years, a large number of miRNAs have been identified in osteoarthritic tissues, which is important in terms of the regulation of gene expressions related to the pathogenesis of OA. OA-specific miRNA expressions is necessary for early diagnosis and treatment of OA as well as for monitoring the progression of the disease. It has been reported that miRNA-146a is intensely expressed in OA tissue and its expression is induced by inflammatory cytokines. MiRNA-145 is associated with chondrocyte homeostasis and is thought to be involved in the degradation of the extracellular matrix. MiRNA-155 is a miRNA that has a role in the development and regulation of innate and acquired immunity, and its expression is increased in tissues with OA compared to healthy tissue. It has an important role in hematopoiesis. MiRNA-221-3p was found to be associated with chondrocyte proliferation, gene expression, matrix degradation and apoptosis.
In this study it was aimed to determine the changes in miRNA levels of knee OA patients with exercise.
- Conditions
- Osteoarthritis, Knee, Epigenetic Disorder, Quality of Life, Depression, Pain
- Being tested
- Exercise Programme, Experiments
- Keywords
- Osteoarthritis, Epigenetic Disorder, Quality of Life, Depression, Pain
- Medical subject headings
- Osteoarthritis, Knee, Depression, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgrammeOther
All patients were informed about knee OA, joint protection principles, and the exercise effects on knee OA before treatment. The exercises were supervised by a physiotherapist for 30 minutes twice a week and once a week as a home program. The exercise program consisted of a warm-up, strengthening knee extensors and lower extremity stretching exercises. Firstly, quadriceps isometric and adductor isometric (roll tightening) exercises, hamstring stretching, quadriceps stretching, and gastrocnemius stretching were applied. Then, hip flexion-extension-abduction-adduction, and knee extension while sitting were applied with exercise bands. Strengthening exercises were composed of three sets with 10 repetitions. Stretching exercises were performed 10 repetitions for 10 seconds.
ExperimentsOther
The total RNA was isolated from peripheral blood samples taken from patients and the control group by applying the protocol of the manufacturer (LucigenMasterPure™ Complete DNA and RNA Purification Kit, USA). The total RNA was isolated in three steps: Lysis stage of the whole blood samples, precipitation of nucleic acids and precipitation of total RNA. The purity and concentration of the isolated total RNA samples were measured with the spectrophotometer (Thermo Fischer) device. The samples were stored at -80°C until the next step. To determine the microRNA expression levels; firstly, conjugate DNA (cDNA) was synthesized from total RNA samples according to the manufacturer's protocol. Whether the desired region reproduced in the reaction and whether there were primer dimers were checked by adding a melting curve step. In addition, blood samples of 30 age-sex matched healthy volunteers were compared.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | A total of 30 knee OA patients and 30 age/sex-matched healthy volunteers were included in the exercise and control groups. Exercises were performed twice a week under supervision and once a week as home program for eight weeks. Before and after exercise treatment, peripheral venous blood samples were taken from both groups. miRNA-146a, miRNA-155, miRNA-221-3p and miRNA-145 gene expressions were studied with the Real-time PCR method. miRNA-146a, miRNA-155, and miRNA-221-3p, miRNA-145 gene expressions were studied with the Real-time PCR method. The pain was evaluated with the Numeric Rating Scale (NRS), functional status with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), depression level with the Beck Depression Inventory (BDI), and quality of life with Short Form-36 (SF-36). Receives: Other: Exercise Programme; Other: Experiments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Treatment Gene Expressions of microRNA for Treatment Group
By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.
Measured: Baseline
Post-Treatment Gene Expressions of microRNA for Treatment Group
By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.
Measured: Through study completion, an average of 2 months.
Gene Expressions of microRNA for Healthy Control Group
By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.
Measured: Baseline
Pre-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group
WOMAC was used to evaluate functional status. There are a total of 24 questions on pain, morning stiffness and physical function.
0 points means 'not at all', 1 point means 'mild', 2 points 'moderate', 3 points 'severe', 4 points 'very severe'.
The total score is between 0 and 100, and a low score means that the individual is in good health.
Measured: Baseline
Post-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group
WOMAC was used to evaluate functional status. There are a total of 24 questions on pain, morning stiffness and physical function.
0 points means 'not at all', 1 point means 'mild', 2 points 'moderate', 3 points 'severe', 4 points 'very severe'.
The total score is between 0 and 100, and a low score means that the individual is in good health.
Measured: At the beginning of the intervention and through study completion, an average of 2 month
Secondary outcomes (3)
Short Form-36 (SF-36)
SF-36 was used to evaluate quality of life. This questionnaire consists of eight subsections. Scoring is made between 0-100 for each of the subsections. Higher scores indicate better function and well-being.
Measured: At the beginning of the intervention and through study completion, an average of 2 month
Beck Depression Inventory (BDI)
BDI was used to evaluate depression level. The test consists of 20 questions and each question includes 0, 1, 2, 3 points.
takes. At the end of the test; The scores marked by the patient for each question are summed up and the depression status is evaluated according to the score. The higher the score, the higher the level of depression.
Measured: At the beginning of the intervention and through study completion, an average of 2 month
Numeric Rating Scale (NRS)
NRS was used to pain level. A score of 0 means 'no pain' and a score of 10 means 'unbearable pain'.
Measured: At the beginning of the intervention and through study completion, an average of 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Aug 2018
- Primary completion11 Sep 2019
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort Study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fulya Senem KARAAHMETOĞLU, M.Sc, Principal investigator, Saglik Bilimleri UniversitesiZeynep Betül ÖZCAN, M.Sc, Study chair, Saglik Bilimleri UniversitesiMeltem VURAL, Prof. Dr., Study chair, Istanbul Bakırköy Dr.Sadi Konuk Training and Research HospitaIşıl ÜSTÜN, Dr., Study chair, Istanbul Bakırköy Dr.Sadi Konuk Training and Research HospitaAlev KURAL, Prof. Dr., Study chair, Istanbul Bakırköy Dr.Sadi Konuk Training and Research HospitaSibel KURAŞ, M. Sc., Study chair, Saglik Bilimleri UniversitesiBekir ERDOĞAN, M.Sc, Study chair, Saglik Bilimleri UniversitesiHalime Hanım PENÇE, Assoc. Prof., Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869630
- Sponsor's protocol ID
- OA_exercise_microrna
- Status last verified
- May 2023
- First submitted
- 6 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05869630
- Acronym / sponsor ID
- OA_exercise_microrna
- Conditions
- Osteoarthritis, Knee, Epigenetic Disorder, Quality of Life, Depression, Pain
- Keywords
- Osteoarthritis, Epigenetic Disorder, Quality of Life, Depression, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a prospective cohort study. This study will be conducted to determine the change in miRNA levels with exercise in knee Osteoarthritis (OA) patients. The main questions that the study aims to answer are:
Question 1: Does exercise therapy affect microrna expressions in patients with knee osteoarthritis?
Question 2: Does exercise therapy affect quality of life, pain, functional status and depression level in patients with knee osteoarthritis?
Participants; demographic information such as age, height, weight will be questioned. Exercises will performed twice a week under supervision and once a week as home program for eight weeks. Before and after exercise treatment, peripheral venous blood samples will taken from both groups. miRNA-146a, miRNA-155, miRNA-221-3p and miRNA-145 gene expressions will studied with the real-time PCR (polymerase chain reaction) method. miRNA-146a, miRNA-155, and miRNA-221-3p, miRNA-145 gene expressions will studied with the Real-time PCR method. The pain will evaluated with the Numeric Rating Scale (NRS), functional status with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), depression level with the Beck Depression Inventory (BDI), and quality of life with Short Form-36 (SF-36).
Detailed description
Osteoarthritis is a degenerative disease causing joint pain, stiffness, and limitation of motion with loss of cartilage, osteophyte development, subchondral sclerosis, changes in the joint capsule and synovial membrane as a result of the disruption of genetic, biomechanical, and biochemical balances. Pharmacological treatments of osteoarthritis include simple analgesics, non-steroidal anti-inflammatory drugs, opioids and topical analgesics. Patient education, self-management programs, exercise, weight loss, assistive devices and lifestyle changes are non-pharmacological treatment methods.Exercise is one of the basic elements of the treatment modality. The purpose of the exercise; to relieve symptoms and improve muscle strength around joints. It is aimed to increase the quality of life with the adaptation of individuals to exercise.
miRNA, one of the small non-coding RNA subunits, is responsible for the modulation of protein-coding genes as a result of post-transcriptional repression. miRNA play an active role in many biological events such as cellular differentiation, apoptosis, proliferation, erythropoiesis, fibrosis and angiogenesis. Due to the role of miRNAs in normal development and diseases, it is thought that they will be a new biomarker for therapeutic purposes in the future. It was found that miRNAs play a key role in physiological conditions e.g. skeletal muscle hypertrophy, mitochondrial biogenesis, vascular angiogenesis, and metabolic events when combined with exercise. The identification of miRNAs that change in circulation with exercise is important in terms of providing new data on the physiological adaptation of exercise. In recent years, a large number of miRNAs have been identified in osteoarthritic tissues, which is important in terms of the regulation of gene expressions related to the pathogenesis of OA. OA-specific miRNA expressions is necessary for early diagnosis and treatment of OA as well as for monitoring the progression of the disease. It has been reported that miRNA-146a is intensely expressed in OA tissue and its expression is induced by inflammatory cytokines. MiRNA-145 is associated with chondrocyte homeostasis and is thought to be involved in the degradation of the extracellular matrix. MiRNA-155 is a miRNA that has a role in the development and regulation of innate and acquired immunity, and its expression is increased in tissues with OA compared to healthy tissue. It has an important role in hematopoiesis. MiRNA-221-3p was found to be associated with chondrocyte proliferation, gene expression, matrix degradation and apoptosis.
In this study it was aimed to determine the changes in miRNA levels of knee OA patients with exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise Programme, Other: ExperimentsA total of 30 knee OA patients and 30 age/sex-matched healthy volunteers were included in the exercise and control groups. Exercises were performed twice a week under supervision and once a week as home program for eight weeks. Before and after exercise treatment, peripheral venous blood samples were taken from both groups. miRNA-146a, miRNA-155, miRNA-221-3p and miRNA-145 gene expressions were studied with the Real-time PCR method. miRNA-146a, miRNA-155, and miRNA-221-3p, miRNA-145 gene expressions were studied with the Real-time PCR method. The pain was evaluated with the Numeric Rating Scale (NRS), functional status with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), depression level with the Beck Depression Inventory (BDI), and quality of life with Short Form-36 (SF-36). |
Who may qualify
- Ages
- 38 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having Kellgren-Lawrence grade 2 or grade 3 knee OA
- Body mass index (BMI) between 20-35.
Key exclusion criteria (8 listed)
- Rheumatoid Arthritis,
- Having knee replacement surgery,
- Intra-articular injection in the last six months,
- Usage of opioid analgesics or corticosteroids,
- Being under severe pain (VAS>7),
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 |
|---|---|---|
| Exercise ProgrammeAll patients were informed about knee OA, joint protection principles, and the exercise effects on knee OA before treatment. The exercises were supervised by a physiotherapist for 30 minutes twice a week and once a week as a home program. The exercise program consisted of a warm-up, strengthening knee extensors and lower extremity stretching exercises. Firstly, quadriceps isometric and adductor isometric (roll tightening) exercises, hamstring stretching, quadriceps stretching, and gastrocnemius stretching were applied. Then, hip flexion-extension-abduction-adduction, and knee extension while sitting were applied with exercise bands. Strengthening exercises were composed of three sets with 10 repetitions. Stretching exercises were performed 10 repetitions for 10 seconds. | Other | Exercise Group |
| ExperimentsThe total RNA was isolated from peripheral blood samples taken from patients and the control group by applying the protocol of the manufacturer (LucigenMasterPure™ Complete DNA and RNA Purification Kit, USA). The total RNA was isolated in three steps: Lysis stage of the whole blood samples, precipitation of nucleic acids and precipitation of total RNA. The purity and concentration of the isolated total RNA samples were measured with the spectrophotometer (Thermo Fischer) device. The samples were stored at -80°C until the next step. To determine the microRNA expression levels; firstly, conjugate DNA (cDNA) was synthesized from total RNA samples according to the manufacturer's protocol. Whether the desired region reproduced in the reaction and whether there were primer dimers were checked by adding a melting curve step. In addition, blood samples of 30 age-sex matched healthy volunteers were compared. | Other | Exercise Group |
Primary outcome
Pre-Treatment Gene Expressions of microRNA for Treatment Group
Time frame: Baseline
By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.
Post-Treatment Gene Expressions of microRNA for Treatment Group
Time frame: Through study completion, an average of 2 months.
By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.
Gene Expressions of microRNA for Healthy Control Group
Time frame: Baseline
By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.
Pre-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group
Time frame: Baseline
WOMAC was used to evaluate functional status. There are a total of 24 questions on pain, morning stiffness and physical function. 0 points means 'not at all', 1 point means 'mild', 2 points 'moderate', 3 points 'severe', 4 points 'very severe'. The total score is between 0 and 100, and a low score means that the individual is in good health.
Post-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group
Time frame: At the beginning of the intervention and through study completion, an average of 2 month
WOMAC was used to evaluate functional status. There are a total of 24 questions on pain, morning stiffness and physical function. 0 points means 'not at all', 1 point means 'mild', 2 points 'moderate', 3 points 'severe', 4 points 'very severe'. The total score is between 0 and 100, and a low score means that the individual is in good health.
3 secondary outcomes
Short Form-36 (SF-36)
Time frame: At the beginning of the intervention and through study completion, an average of 2 month
Beck Depression Inventory (BDI)
Time frame: At the beginning of the intervention and through study completion, an average of 2 month
Numeric Rating Scale (NRS)
Time frame: At the beginning of the intervention and through study completion, an average of 2 month
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 Jun 2023.
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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.
Fulya Senem KARAAHMETOĞLU, M.Sc principal investigator
Saglik Bilimleri Universitesi
Zeynep Betül ÖZCAN, M.Sc study chair
Saglik Bilimleri Universitesi
Meltem VURAL, Prof. Dr. study chair
Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Programme and Experiments in people with Osteoarthritis, Knee and Epigenetic Disorder, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 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 Jun 2023. 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 Turkey (Türkiye). 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?
Pre-Treatment Gene Expressions of microRNA for Treatment Group (time frame: Baseline). The study lists 5 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 6 Jun 2023.