PainNCT04911673
Effectiveness of Dark Chocolate and Music in Dysmenorrhea
A study testing music and Chocolate group in people with Pain and Primary Dysmenorrhea, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Primary dysmenorrhea (PD) is a pain that occurs in the menstrual period without pathological pelvic disorder. Excessive prostaglandin release causes uterine contraction and leads to uterine hypoxia and ischemia, which results in extreme abdominal cramps and pain. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Primary Dysmenorrhea, Menstrual Pain
- What is being tested?
- music and Chocolate group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2021to 30 Dec 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Legal and cognitive capacity for informed consent.
- Suffering from primary dysmenorrhea (low abdominal pain associated to menses). (five and above in VAS)
- Being able to understand and use the measuring tools and questionnaires.
- 18-25 years old
- Studying in Manisa Celal Bayar University, Faculty of Health Sciences, Department of Nursing, in the 2020-2021 academic year, in the 1st, 2nd, 3rd and 4th grades,
Who cannot join
- Previous diagnosis of pelvic pathology.
- Diagnosis of hearing impairment.
- Diagnosis of neurologic or endocrinological disease.
- Psychiatric condition diagnosed.
- Known or reported previous substance abuse.
- Current use of psychiatric drugs.
Show all 16Show fewer
- Cancer diagnosis
- Diagnosed chronic diseases such as diabetes mellitus or heart disease.
- Previous advance musical training (defined as any form of music training in addition to that received during normal school classes).
- Irregular menstrual cycles.
- Previous pregnancy.
- Current use of any hormonal contraceptive therapy
- Having allergy to chocolate
- Being obese
- Taking vitamin supplements
- Students who do not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dark Chocolate and Music on Primary Dysmenorrhea
Primary dysmenorrhea (PD) is a pain that occurs in the menstrual period without pathological pelvic disorder. Excessive prostaglandin release causes uterine contraction and leads to uterine hypoxia and ischemia, which results in extreme abdominal cramps and pain. Music therapy is one of the complementary treatment methods in the management of pain for PD which is an intervention that is not expensive and has no side effects. Another complementary treatment method is for PD is chocolate. In the literature; there have a few studies about the effect of the music and dark chocolate on the primary dysmenorrhea but no studies have been conducted to evaluate the effects of the music and dark chocolate on PD.
The following is the protocol for a randomized controlled clinical trial, where an experimental group 1 listened to a 30-minute song, an experimental group 2 ate dark chocolate and a control group had no intervention for the same time and conditions. The aim of this study is to determine the effect of dark chocolate and music on PD. This pain measured through a 10 cm Visual Analogue Scale (VAS) in nursing students from the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey. Additionally, State-Trait Anxiety Inventory (STAI) was used to assess the trait and state anxiety.
Read the detailed description
Primary Dysmenorrhea (PD) is defined as cramping pain in the lower abdomen, which occurs before or during menstruation without pelvic diseases. Contraceptive pills and non steroidal anti inflammatory drugs are commonly used in the treatment of PD. International (66.5% to 92.5%) and Turkey (87.7% to 80.1%) in the studies among university students show that a high percentage of dysmenorrhea. Dysmenorrhea negatively affects the school absenteeism of girls, their academic success and causes a lack of concentration. The rate of using pain medication due to dysmenorrhea is high among students. Music therapy has been shown to be effective in relaxing the mind and body, relieving anxiety, enhancing security, and increasing pain thresholds. Dark chocolate contains copper, which is used by the body to synthesize neurotransmitters called collagen and endorphins. Endorphin hormone is an analgesic and natural sedative to reduce pain intensity such as menstrual pain.
This randomized clinical trial was designed to determine the effect of eating dark chocolate and listening music on PD, compared to a control group that no intervention in women of 18 years or older from the the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey.
- Conditions
- Pain, Primary Dysmenorrhea, Menstrual Pain
- Being tested
- music, Chocolate group
- Keywords
- music, dark chocolate, dysmenorrhea, pain
- Medical subject headings
- Pain, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicBehavioural
Participants listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation).
Chocolate groupDietary supplement
Participants ate 40 mg of dark chocolate with 60% cocoa per a day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them.
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | Participants listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song was composed by Juan Martin Saavedra.
In the first month, music group was filled the State Anxiety Inventory (SAI) between 10 and 20th of the menstruation that SAI consists of 20 statements that ask people to describe how they generally feel. In the second month, pain scores were measured on the first day of menstruation using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain) and Trait Anxiety Inventory (TAI) was filled to assess the anxiety.In the third month, after the participants were listening the music in three days before menstruation and the first day of menstruation (during four days), pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. Receives: Behavioral: music |
| Chocolate group | Experimental | Participants ate 40 mg of dark chocolate with 60% cocoa per day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them. In the first month, chocolate group was filled the SAI to assess state anxiety between 10 and 20th of the menstruation.In the second month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the trait anxiety.In the third month, after the participants were eating 40 mg of dark chocolate per day in three days before menstruation and the first day of menstruation (during four days/total 160 mg), pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. Receives: Dietary Supplement: Chocolate group |
| Control group | No intervention | Control group had no intervention. In the first month, control group was filled the SAI to assess state anxiety between 10 and 20th of the menstruation. In the second month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the trait anxiety. In the third month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the students' demographics and clinical backgrounds.
Questions about the sociodemographic characteristics and dysmenorrhea characteristics of the students were asked using the individual identification form developed by the researchers in line with the literature.
Measured: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
To evaluate pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
We asked them to determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0.
Measured: The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
To evaluate the effect of dark chocolate consumption in reducing the pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
We asked them to eat dark chocolate and determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0. Participants ate 40 mg of dark chocolate per day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them.
Measured: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
To evaluate the effect of music consumption in reducing the pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
We asked them listen to music and to determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0. Students listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). Participants were instructed to avoid using cellphones or other activities during the time of the intervention.
Measured: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
To evaluate anxiety level in the first day of first menstruation cycle through State Anxiety Inventory (SAI).
In the first day of first menstrual cycle, students was filled the State Anxiety Inventory (SAI) that SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
To evaluate the effect of dark chocolate consumption in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
We asked them to eat dark chocolate and filled the State Anxiety Inventory (SAI)in the first day of first menstrual cycle. The SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
To evaluate the effect of the music in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
We asked them to listen the music and filled the State Anxiety Inventory (SAI)in the first day of first menstrual cycle. The SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start30 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Baysal, Manisa Celal Bayar University
- Investigators
- EBRU BAYSAL, PhD, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911673
- Sponsor's protocol ID
- CelalBayar
- Status last verified
- Mar 2022
- First submitted
- 20 May 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dark Chocolate and Music on Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04911673
- Acronym / sponsor ID
- CelalBayar
- Conditions
- Pain, Primary Dysmenorrhea, Menstrual Pain
- Keywords
- music, dark chocolate, dysmenorrhea, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 3 Jun 2021 (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.
Primary dysmenorrhea (PD) is a pain that occurs in the menstrual period without pathological pelvic disorder. Excessive prostaglandin release causes uterine contraction and leads to uterine hypoxia and ischemia, which results in extreme abdominal cramps and pain. Music therapy is one of the complementary treatment methods in the management of pain for PD which is an intervention that is not expensive and has no side effects. Another complementary treatment method is for PD is chocolate. In the literature; there have a few studies about the effect of the music and dark chocolate on the primary dysmenorrhea but no studies have been conducted to evaluate the effects of the music and dark chocolate on PD.
The following is the protocol for a randomized controlled clinical trial, where an experimental group 1 listened to a 30-minute song, an experimental group 2 ate dark chocolate and a control group had no intervention for the same time and conditions. The aim of this study is to determine the effect of dark chocolate and music on PD. This pain measured through a 10 cm Visual Analogue Scale (VAS) in nursing students from the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey. Additionally, State-Trait Anxiety Inventory (STAI) was used to assess the trait and state anxiety.
Detailed description
Primary Dysmenorrhea (PD) is defined as cramping pain in the lower abdomen, which occurs before or during menstruation without pelvic diseases. Contraceptive pills and non steroidal anti inflammatory drugs are commonly used in the treatment of PD. International (66.5% to 92.5%) and Turkey (87.7% to 80.1%) in the studies among university students show that a high percentage of dysmenorrhea. Dysmenorrhea negatively affects the school absenteeism of girls, their academic success and causes a lack of concentration. The rate of using pain medication due to dysmenorrhea is high among students. Music therapy has been shown to be effective in relaxing the mind and body, relieving anxiety, enhancing security, and increasing pain thresholds. Dark chocolate contains copper, which is used by the body to synthesize neurotransmitters called collagen and endorphins. Endorphin hormone is an analgesic and natural sedative to reduce pain intensity such as menstrual pain.
This randomized clinical trial was designed to determine the effect of eating dark chocolate and listening music on PD, compared to a control group that no intervention in women of 18 years or older from the the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Behavioral: musicParticipants listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song was composed by Juan Martin Saavedra. In the first month, music group was filled the State Anxiety Inventory (SAI) between 10 and 20th of the menstruation that SAI consists of 20 statements that ask people to describe how they generally feel. In the second month, pain scores were measured on the first day of menstruation using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain) and Trait Anxiety Inventory (TAI) was filled to assess the anxiety.In the third month, after the participants were listening the music in three days before menstruation and the first day of menstruation (during four days), pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. |
| Chocolate group | Experimental | Dietary Supplement: Chocolate groupParticipants ate 40 mg of dark chocolate with 60% cocoa per day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them. In the first month, chocolate group was filled the SAI to assess state anxiety between 10 and 20th of the menstruation.In the second month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the trait anxiety.In the third month, after the participants were eating 40 mg of dark chocolate per day in three days before menstruation and the first day of menstruation (during four days/total 160 mg), pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. |
| Control group | No intervention | –Control group had no intervention. In the first month, control group was filled the SAI to assess state anxiety between 10 and 20th of the menstruation. In the second month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the trait anxiety. In the third month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Legal and cognitive capacity for informed consent.
- Suffering from primary dysmenorrhea (low abdominal pain associated to menses). (five and above in VAS)
- Being able to understand and use the measuring tools and questionnaires.
- 18-25 years old
- Studying in Manisa Celal Bayar University, Faculty of Health Sciences, Department of Nursing, in the 2020-2021 academic year, in the 1st, 2nd, 3rd and 4th grades,
Key exclusion criteria (16 listed)
- Previous diagnosis of pelvic pathology.
- Diagnosis of hearing impairment.
- Diagnosis of neurologic or endocrinological disease.
- Psychiatric condition diagnosed.
- Known or reported previous substance abuse.
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 |
|---|---|---|
| musicParticipants listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). | Behavioural | Music group |
| Chocolate groupParticipants ate 40 mg of dark chocolate with 60% cocoa per a day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them. | Dietary supplement | Chocolate group |
Primary outcome
Description of the students' demographics and clinical backgrounds.
Time frame: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
Questions about the sociodemographic characteristics and dysmenorrhea characteristics of the students were asked using the individual identification form developed by the researchers in line with the literature.
To evaluate pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
Time frame: The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
We asked them to determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0.
To evaluate the effect of dark chocolate consumption in reducing the pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
Time frame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
We asked them to eat dark chocolate and determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0. Participants ate 40 mg of dark chocolate per day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them.
To evaluate the effect of music consumption in reducing the pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
Time frame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
We asked them listen to music and to determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0. Students listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). Participants were instructed to avoid using cellphones or other activities during the time of the intervention.
To evaluate anxiety level in the first day of first menstruation cycle through State Anxiety Inventory (SAI).
Time frame: The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
In the first day of first menstrual cycle, students was filled the State Anxiety Inventory (SAI) that SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
To evaluate the effect of dark chocolate consumption in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
Time frame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
We asked them to eat dark chocolate and filled the State Anxiety Inventory (SAI)in the first day of first menstrual cycle. The SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
To evaluate the effect of the music in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
Time frame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
We asked them to listen the music and filled the State Anxiety Inventory (SAI)in the first day of first menstrual cycle. The SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
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 11 Mar 2022.
- 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.
EBRU BAYSAL, PhD principal investigator
Manisa Celal Bayar 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 music and Chocolate group in people with Pain and Primary Dysmenorrhea, run by Manisa Celal Bayar 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 5 inclusion and 16 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 11 Mar 2022. 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?
Description of the students' demographics and clinical backgrounds. (time frame: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.). The study lists 7 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 11 Mar 2022.