Manual Lymphatic DrainageNCT05976399
Manual Lymph Drainage in Individuals With Migraine
A study testing Connective Tissue Massage and Manual Lymph Drainage in people with Manual Lymphatic Drainage, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, research into the examination of the effect of MLD on migraine is quite limited. Our study aimed to examine the effectiveness of manual lymph drainage and connective tissue massage treatments on neck pain and disability, sleep quality, pain threshold and severity, depression and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Manual Lymphatic Drainage
- What is being tested?
- Connective Tissue Massage and Manual Lymph Drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2019to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be able to read and write
- Diagnosis of migraine by a neurologist according to IHS criteria
- Be willing to participate in the study voluntarily signing an informed consent form
- Have good cognitive functioning
- Between the ages of 18 and 65
- Reported pain intensity of 40 mm or more according to VAS
- Headache (without allodynia) <15 days per month
Who cannot join
- Had any of the contraindications of MLD for the general and neck region
- Had a history of neuromuscular disease,
- Had communication problems to the extent that prevented evaluation methods,
- Had headaches lasting >15 days a month, were diagnosed with other types of headaches (cervicogenic type headache, tension-type headache),
- Were diagnosed with fibromyalgia or myofascial pain syndrome, exhibited whiplash and similar traumas
- Had severe depression symptoms according to the Beck depression inventory,
- Had a congenital musculoskeletal anomaly, received non-pharmacological migraine treatment (acupuncture, dry needling, etc.),
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Democracy University
Izmir, Karabağlar/İZMİR, 35140
About this study
Official title: The Investigation of The Effectiveness Of Manual Lymph Drainage in Individuals With Migraine
In the literature, research into the examination of the effect of MLD on migraine is quite limited. Our study aimed to examine the effectiveness of manual lymph drainage and connective tissue massage treatments on neck pain and disability, sleep quality, pain threshold and severity, depression and quality of life.
Read the detailed description
Although there are evidence-based guidelines for clinical decision-making and reporting the care of patients with migraine, migraine management for the population is inadequate. Even among individuals who are correctly diagnosed, almost more than half of patients are not administered any acute or preventive treatment. Various invasive and non-invasive treatment options are available in the treatment of migraine. Relaxation training, exercise, cold application, massage, transcutaneous electrical nerve stimulation (TENS), biofeedback, manipulation and mobilization techniques, and trigger point therapy are some of the non-invasive treatment options used in migraine treatment. These treatments, which can be applied independently, can also be applied in combination with pharmacological treatments in some patients. In addition, the patient's knowledge about the disease makes it easier to manage the process and cope with the pain better.
Connective tissue massage (CTM) is a manipulative therapy method that is different from traditional massages in terms of both technical and physiological effects and has been used for diagnosis or treatment since 1928. Although the manipulative procedures applied target superficial connective and subcutaneous tissues, they also have effects on organs far from the local stimulation area. Another approach to migraine prophylaxis includes manual lymph drainage (MLD). It is considered that MLD causes sympathetic and parasympathetic effects and is similar to therapeutically effective relaxation therapy by reducing the hyperexcitability of the central system. With the parasympathetic effect it creates, it helps to reduce muscle pain and spasm, making it easier to cope with tension and stress. Reduction of the tension and stress factors may reduce the triggering of migraine and make it easier to cope with the current migraine. Recent studies have shown that the meningeal lymphatic system is located in the brain and that this system is a new way for the drainage of the cerebrospinal fluid.
In the literature, research into the examination of the effect of MLD on migraine is quite limited. We planned this randomized controlled trial to contribute to the reduction of pain and increase the quality of life of individuals with migraine by increasing the awareness of individuals working in this field in our country.
- Conditions
- Manual Lymphatic Drainage
- Being tested
- Connective Tissue Massage, Manual Lymph Drainage
- Keywords
- Migraine, Manual Lymphatic Drainage, Connective Tissue Massage, Quality of Life
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue MassageOther
In participants in the CTM group, the treatment was started with the sacral region called the "basic region" and the whole back was treated. Pulls in the interscapular region were more intense than in other regions. After the interscapular region, the cervical, clavicular, and facial regions were also included in the treatment. Both short and long pulls were used according to the region during CTM. The applications first started with the basic region and then progressed to the lower thoracic, scapular, and interscapular regions. Then, the cervical and clavicular regions were treated. In each region, the applications were performed three times on each of the right and left sides. While positioning the patients, we paid attention to their privacy and the temperature of the room where the treatment was carried out. A total of 12 sessions, which were conducted 2 days a week and took 6 weeks, were performed.
Manual Lymph DrainageOther
The patients, who had filled out their pain diary before and submitted a consent form, were first evaluated before the treatment and then they lay on their back with their neck area open, paying attention to the protection of their privacy. Hand strokes, one of the basic techniques applied for treatment, were planned in accordance with the anatomy and physiology of the lymphatic system. MLD was applied to the lateral neck and face region in 5-7 repetitions so that the lymph collectors could give an adequate reaction to the application. The treatment was performed 2 days a week for 6 weeks, with a total of 12 sessions. Each session lasted 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Manual lymph drainage group | Active comparator | The patients, who had filled out their pain diary before and submitted a consent form, were first evaluated before the treatment and then they lay on their back with their neck area open, paying attention to the protection of their privacy. Hand strokes, one of the basic techniques applied for treatment, were planned in accordance with the anatomy and physiology of the lymphatic system. MLD was applied to the lateral neck and face region in 5-7 repetitions so that the lymph collectors could give an adequate reaction to the application. The treatment was performed 2 days a week for 6 weeks, with a total of 12 sessions. Each session lasted 45 minutes. Receives: Other: Manual Lymph Drainage |
| Connective tissue massage group | Active comparator | In participants in the CTM group, the treatment was started with the sacral region called the "basic region" and the whole back was treated. Pulls in the interscapular region were more intense than in other regions. After the interscapular region, the cervical, clavicular, and facial regions were also included in the treatment. The applications first started with the basic region and then progressed to the lower thoracic, scapular, and interscapular regions. Then, the cervical and clavicular regions were treated. In each region, the applications were performed three times on each of the right and left sides. While positioning the patients, we paid attention to their privacy and the temperature of the room where the treatment was carried out. A total of 12 sessions, which were conducted 2 days a week and took 6 weeks, were performed. Receives: Other: Connective Tissue Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure algometer (Dolorimeter)
The pressure algometer was developed by Fischer to determine the perception of pressure and assess pain sensitivity. in our study, measurements with a dolorimeter were made from a total of 12 regions, including 6 on the right and 6 on the left. Selected 6 muscles were M. Temporalis anterior, M. Sternocleidomastoid, M. Scalenous anterior, M. Suboccipital, M. Levator scapula, and M. Trapezius (Upper).
Measured: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Secondary outcomes (6)
Neck Pain and Disability Scale
It consists of 20 questions that examine the relationship between the severity of neck pain and social, functional, and emotional status. The questions on the scale are scored between 0 and 5 points. A high score indicates severe disability in patients.
Measured: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Visual Analog Scale
The severity of individuals' pain was evaluated using the visual analog scale. The patient evaluates his or her subjective pain sensation with this scale. It is a 100-mm-long horizontal or vertical scale, where 0 indicates no pain and 10 indicates the most severe pain possible
Measured: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Pain diary
This is a method that is used to plan treatment and determine its effectiveness. It includes a diary in which the patient records information, such as the onset of pain, its severity, location, factors that increase or decrease it, and the name and dose of the medication used if any. Forty patients with migraine who were planned to be included in the study were given a pain diary 2 weeks before the initiation of treatment. Patients were asked to record the severity and duration of the pain, the symptoms accompanying it, and the name and the number of medications taken in the pain diary when they had a headache.
Measured: in the study a pain diary were given 2 weeks before the initiation of treatment and after the 6-week-long treatment was completed
Short Form-36
This form was developed by Ware Jr and Sherbourne to evaluate the quality of life.It consists of 36 items that measure 8 dimensions: physical functioning, role limitations due to physical problems, social functioning, role limitations due to emotional problems, pain, mental health, the general perception of health, and energy/vitality. The dimensions are independent of each other, and a high score indicates the quality of life for that dimension.
Measured: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Back Depression Inventory
he Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: All individuals participating in the study were evaluated before and after the 6-week-long treatment
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Measured: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start6 Jun 2019
- Primary completion15 Oct 2020
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Manual Lymphatic DrainageStudies 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
- The study included forty individuals with migraine. Participants' neck pain was evaluated with the Neck Pain and Disability Scale, pressure perceptions and pain sensitivity with an algometer, quality of life with the Short Form-3, and headaches with a pain diary kept for 15 days before and after treatment. Then, the individuals were randomly divided into two as the manual lymph drainage group and the connective tissue massage group. Both groups were treated for 45 minutes twice a week for 6 weeks. The groups were assessed before the treatment and at the end of 6 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Çınar Özdemir, Izmir Democracy University
- Investigators
- Özlem Çinar Özdemir, Assoc.Dr, Study director, Izmir Democracy UniversityBetül Yıldırım, Principal investigator, Siirt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976399
- Sponsor's protocol ID
- MLD in Migraine
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goadsby PJ, Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S. Pathophysiology of Migraine: A Disorder of Sensory Processing. Physiol Rev. 2017 Apr;97(2):553-622. doi: 10.1152/physrev.00034.2015.
PubMed 28179394Goats GC, Keir KA. Connective tissue massage. Br J Sports Med. 1991 Sep;25(3):131-3. doi: 10.1136/bjsm.25.3.131.
PubMed 1777777Happe S, Peikert A, Siegert R, Evers S. Erratum to: The efficacy of lymphatic drainage and traditional massage in the prophylaxis of migraine: a randomized, controlled parallel group study. Neurol Sci. 2016 Oct;37(10):1753. doi: 10.1007/s10072-016-2657-z. No abstract available.
PubMed 27412032Yildirim Bulut B, Cinar Ozdemir O. Comparison of the efficacy of connective tissue massage and manual lymphatic drainage in patients with migraine: a randomized controlled trial. J Oral Facial Pain Headache. 2025 Sep;39(3):121-132. doi: 10.22514/jofph.2025.054. Epub 2025 Sep 12.
PubMed 41070573
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of The Effectiveness Of Manual Lymph Drainage in Individuals With Migraine
- ClinicalTrials.gov ID
- NCT05976399
- Acronym / sponsor ID
- MLD in Migraine
- Conditions
- Manual Lymphatic Drainage
- Keywords
- Migraine, Manual Lymphatic Drainage, Connective Tissue Massage, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 4 Aug 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.
In the literature, research into the examination of the effect of MLD on migraine is quite limited. Our study aimed to examine the effectiveness of manual lymph drainage and connective tissue massage treatments on neck pain and disability, sleep quality, pain threshold and severity, depression and quality of life.
Detailed description
Although there are evidence-based guidelines for clinical decision-making and reporting the care of patients with migraine, migraine management for the population is inadequate. Even among individuals who are correctly diagnosed, almost more than half of patients are not administered any acute or preventive treatment. Various invasive and non-invasive treatment options are available in the treatment of migraine. Relaxation training, exercise, cold application, massage, transcutaneous electrical nerve stimulation (TENS), biofeedback, manipulation and mobilization techniques, and trigger point therapy are some of the non-invasive treatment options used in migraine treatment. These treatments, which can be applied independently, can also be applied in combination with pharmacological treatments in some patients. In addition, the patient's knowledge about the disease makes it easier to manage the process and cope with the pain better.
Connective tissue massage (CTM) is a manipulative therapy method that is different from traditional massages in terms of both technical and physiological effects and has been used for diagnosis or treatment since 1928. Although the manipulative procedures applied target superficial connective and subcutaneous tissues, they also have effects on organs far from the local stimulation area. Another approach to migraine prophylaxis includes manual lymph drainage (MLD). It is considered that MLD causes sympathetic and parasympathetic effects and is similar to therapeutically effective relaxation therapy by reducing the hyperexcitability of the central system. With the parasympathetic effect it creates, it helps to reduce muscle pain and spasm, making it easier to cope with tension and stress. Reduction of the tension and stress factors may reduce the triggering of migraine and make it easier to cope with the current migraine. Recent studies have shown that the meningeal lymphatic system is located in the brain and that this system is a new way for the drainage of the cerebrospinal fluid.
In the literature, research into the examination of the effect of MLD on migraine is quite limited. We planned this randomized controlled trial to contribute to the reduction of pain and increase the quality of life of individuals with migraine by increasing the awareness of individuals working in this field in our country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study included forty individuals with migraine. Participants' neck pain was evaluated with the Neck Pain and Disability Scale, pressure perceptions and pain sensitivity with an algometer, quality of life with the Short Form-3, and headaches with a pain diary kept for 15 days before and after treatment. Then, the individuals were randomly divided into two as the manual lymph drainage group and the connective tissue massage group. Both groups were treated for 45 minutes twice a week for 6 weeks. The groups were assessed before the treatment and at the end of 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Manual lymph drainage group | Active comparator | Other: Manual Lymph DrainageThe patients, who had filled out their pain diary before and submitted a consent form, were first evaluated before the treatment and then they lay on their back with their neck area open, paying attention to the protection of their privacy. Hand strokes, one of the basic techniques applied for treatment, were planned in accordance with the anatomy and physiology of the lymphatic system. MLD was applied to the lateral neck and face region in 5-7 repetitions so that the lymph collectors could give an adequate reaction to the application. The treatment was performed 2 days a week for 6 weeks, with a total of 12 sessions. Each session lasted 45 minutes. |
| Connective tissue massage group | Active comparator | Other: Connective Tissue MassageIn participants in the CTM group, the treatment was started with the sacral region called the "basic region" and the whole back was treated. Pulls in the interscapular region were more intense than in other regions. After the interscapular region, the cervical, clavicular, and facial regions were also included in the treatment. The applications first started with the basic region and then progressed to the lower thoracic, scapular, and interscapular regions. Then, the cervical and clavicular regions were treated. In each region, the applications were performed three times on each of the right and left sides. While positioning the patients, we paid attention to their privacy and the temperature of the room where the treatment was carried out. A total of 12 sessions, which were conducted 2 days a week and took 6 weeks, were performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be able to read and write
- Diagnosis of migraine by a neurologist according to IHS criteria
- Be willing to participate in the study voluntarily signing an informed consent form
- Have good cognitive functioning
- Between the ages of 18 and 65
Key exclusion criteria (7 listed)
- Had any of the contraindications of MLD for the general and neck region
- Had a history of neuromuscular disease,
- Had communication problems to the extent that prevented evaluation methods,
- Had headaches lasting >15 days a month, were diagnosed with other types of headaches (cervicogenic type headache, tension-type headache),
- Were diagnosed with fibromyalgia or myofascial pain syndrome, exhibited whiplash and similar traumas
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 |
|---|---|---|
| Connective Tissue MassageIn participants in the CTM group, the treatment was started with the sacral region called the "basic region" and the whole back was treated. Pulls in the interscapular region were more intense than in other regions. After the interscapular region, the cervical, clavicular, and facial regions were also included in the treatment. Both short and long pulls were used according to the region during CTM. The applications first started with the basic region and then progressed to the lower thoracic, scapular, and interscapular regions. Then, the cervical and clavicular regions were treated. In each region, the applications were performed three times on each of the right and left sides. While positioning the patients, we paid attention to their privacy and the temperature of the room where the treatment was carried out. A total of 12 sessions, which were conducted 2 days a week and took 6 weeks, were performed. | Other | Connective tissue massage group |
| Manual Lymph DrainageThe patients, who had filled out their pain diary before and submitted a consent form, were first evaluated before the treatment and then they lay on their back with their neck area open, paying attention to the protection of their privacy. Hand strokes, one of the basic techniques applied for treatment, were planned in accordance with the anatomy and physiology of the lymphatic system. MLD was applied to the lateral neck and face region in 5-7 repetitions so that the lymph collectors could give an adequate reaction to the application. The treatment was performed 2 days a week for 6 weeks, with a total of 12 sessions. Each session lasted 45 minutes. | Other | Manual lymph drainage group |
Primary outcome
Pressure algometer (Dolorimeter)
Time frame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
The pressure algometer was developed by Fischer to determine the perception of pressure and assess pain sensitivity. in our study, measurements with a dolorimeter were made from a total of 12 regions, including 6 on the right and 6 on the left. Selected 6 muscles were M. Temporalis anterior, M. Sternocleidomastoid, M. Scalenous anterior, M. Suboccipital, M. Levator scapula, and M. Trapezius (Upper).
6 secondary outcomes
Neck Pain and Disability Scale
Time frame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Visual Analog Scale
Time frame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Pain diary
Time frame: in the study a pain diary were given 2 weeks before the initiation of treatment and after the 6-week-long treatment was completed
Short Form-36
Time frame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Back Depression Inventory
Time frame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
The Pittsburgh Sleep Quality Index
Time frame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
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 8 Aug 2023.
- Background: PubMed 28179394Goadsby PJ, Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S. Pathophysiology of Migraine: A Disorder of Sensory Processing. Physiol Rev. 2017 Apr;97(2):553-622. doi: 10.1152/physrev.00034.2015.
- Background: PubMed 1777777Goats GC, Keir KA. Connective tissue massage. Br J Sports Med. 1991 Sep;25(3):131-3. doi: 10.1136/bjsm.25.3.131.
- Background: PubMed 27412032Happe S, Peikert A, Siegert R, Evers S. Erratum to: The efficacy of lymphatic drainage and traditional massage in the prophylaxis of migraine: a randomized, controlled parallel group study. Neurol Sci. 2016 Oct;37(10):1753. doi: 10.1007/s10072-016-2657-z. No abstract available.
- Derived from this study: PubMed 41070573Yildirim Bulut B, Cinar Ozdemir O. Comparison of the efficacy of connective tissue massage and manual lymphatic drainage in patients with migraine: a randomized controlled trial. J Oral Facial Pain Headache. 2025 Sep;39(3):121-132. doi: 10.22514/jofph.2025.054. Epub 2025 Sep 12.
- 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.
Özlem Çinar Özdemir, Assoc.Dr study director
Izmir Democracy University
Betül Yıldırım principal investigator
Siirt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue Massage and Manual Lymph Drainage in people with Manual Lymphatic Drainage, run by Izmir Democracy University 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 7 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: finished, as of the sponsor's last update on 8 Aug 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?
Pressure algometer (Dolorimeter) (time frame: All individuals participating in the study were evaluated before and after the 6-week-long treatment). 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 NCT05976399, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.