StressNCT02225847
Effect of Gardening on Brain Activity
A study testing Gardening, Functional Magnetic Resonance Imaging (fMRI) and psychometric assessments in people with Stress and Depression, run by University of Florida at 3 sites in United States.
Trial summary
The objective of the research is to test the hypothesis that participating in group-based gardening activities alters brain network activation and function, and that such change occurring in the brain forms the neurobiological basis for much of the nonphysical activity portion of the therapeutic benefits of gardening… Read more about this study
- Who is it for?
- Ages 26 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression, Anxiety
- What is being tested?
- Gardening, Functional Magnetic Resonance Imaging (fMRI) and psychometric assessments
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2014to May 2015
- 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 26 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women
- 26 - 49 years of age
- Not pregnant
- Non-gardener
- Non-smoker
- Good Health
- Able to participate in all aspects of the study, including working with plants.
Who cannot join
- Uncomfortable in close spaces (claustrophobia)
- Allergies to plants
- Allergies to plant parts like pollen
- Allergies to plant-based foods
- No additions to alcohol or to recreational drugs or prescription medications
- Not suffering from recurring pain, and
- No diseases, disorders or disabilities that affect daily life.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fifield Hall
Gainesville, Florida, 32611
McKnight Brain Institute
Gainesville, Florida, 32611
Wilmot Greenhouse
Gainesville, Florida, 32611
About this study
The objective of the research is to test the hypothesis that participating in group-based gardening activities alters brain network activation and function, and that such change occurring in the brain forms the neurobiological basis for much of the nonphysical activity portion of the therapeutic benefits of gardening and horticultural therapy. Assessment of the effects of the gardening activities on the experimental population will take two approaches, the first being the use of functional Magnetic Resonance Imaging (fMRI) to assess the regions of the brain that may become activated as a consequence of experiencing the cumulative gardening activities and associated stimuli. The allied approach will employ widely used and well-established self-reported assessment instruments that will capture information about the health and well-being that will then provide a psychometrically-based before and after physical and health summary of the participants in the control group and those engaged in the gardening activities.
Read the detailed description
The goal of this project is to better understand how interacting and working with plants in a group gardening activities program that takes place in a greenhouse effects patterns of brain activity and overall health and well-being. There has been essentially no assessment of the effects of gardening or engaging in gardening activities on brain activity using functional MRI (fMRI) approaches. This study will employ visual stimuli to assess the effects of the gardening activities treatment on Blood Oxygen Level Dependent (BOLD) responses as revealed by fMRI in study subjects in a comparison of responses before and after engaging in the gardening intervention program.
Specifically this study seeks to determine whether engaging in gardening activities taking place in a greenhouse can influence brain activity and function, and result in changes in overall quality of life status of subjects in a wellness population.
The total study population (N = 23) will consist of 11 healthy women in the control group, and 12 healthy women in the treatment group. There will be fMRI brain scans and psychometric pre- and post-intervention assessments administered to the study subjects. The fMRI and psychometric assessments will be administered within 10 days prior to the start of the intervention, and within 10 days following the completion of the treatment intervention. The control group will continue with normal daily life over a seven to eight week interval, and receive no other intervention. The treatment group will be divided into two groups of six women each that will receive the gardening intervention on different days of the week. The participants in the treatment group will receive an experimental intervention consisting of 12 gardening sessions, each approximately 60 minutes in duration over a six week treatment period. Each gardening session will take place at the same time of day twice each week, and follow a standardized programming sequence to ensure equivalency of intervention across all gardening sessions. Ambient environmental conditions in the greenhouse during the gardening sessions will be monitored and recorded. The gardening activities will emphasize growing plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste, visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a short educational module introducing the plants and gardening activities taking place during each session. In addition to the pre- and post-intervention assessments, psychometric assessments will be administered for depression and mood states at specific time points during the gardening activities to the treatment group to evaluate any changes over time resulting from the intervention.
- Conditions
- Stress, Depression, Anxiety, Quality of Life
- Being tested
- Gardening, Functional Magnetic Resonance Imaging (fMRI), psychometric assessments
- Keywords
- Gardening, Therapeutic Horticulture, Functional Magnetic Resonance Imaging, Psychometric Assessment, Stress, Depression, Anxiety, Quality of Life, Wellness
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GardeningOther
The intervention consists of twice weekly group sessions of gardening activities of 60 minutes in duration that will take place in a greenhouse. A total of 12 gardening sessions administered over a period of six weeks will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities.
Functional Magnetic Resonance Imaging (fMRI)Procedure or surgery
Functional magnetic resonance imaging will be employed to assess whether engaging in gardening activities in a greenhouse does or does not alter the spatial patterns of brain network activation relative to changes that occur between the groups.
psychometric assessmentsBehavioural
The following assessments will be used: The SF-36 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993), the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988), The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983), the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS), and the Perceived Stress Scale (PSS) (Cohen et al 1983) for changes that occur in between the groups.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Members of this group will continue with their daily life activities and will not receive gardening intervention. The control group will be given a set of psychometric assessments for health and quality of life evaluations and undergo a Functional Magnetic Resonance Imaging (fMRI) brain scan, followed by a second round of psychometric assessments and a fMRI brain scan administered seven to eight weeks after the initial baseline psychometric assessments and fMRI brain scan. Receives: Procedure: Functional Magnetic Resonance Imaging (fMRI); Behavioral: psychometric assessments |
| Gardening | Experimental | Members of this group will be given a set of psychometric assessments for health and quality of life evaluations and a Functional Magnetic Resonance Imaging (fMRI) brain scan prior to receiving the gardening activities intervention. The gardening intervention will consist of twice weekly group sessions lasting 60 minutes in duration that will take place in a greenhouse. The duration of the experimental intervention will be six weeks for a total of 12 individual gardening activity sessions. Following the completion of the gardening intervention, a second round of psychometric assessments and a fMRI brain scan will be administered seven to eight weeks after the initial baseline psychometric assessments and fMRI brain scan. Receives: Other: Gardening; Procedure: Functional Magnetic Resonance Imaging (fMRI); Behavioral: psychometric assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spatial Patterns of Brain Network Activation
Functional magnetic resonance imaging will be employed to assess whether engaging in gardening activities in a greenhouse does or does not alter the spatial patterns of brain network activation relative to changes that occur in the control group.
Measured: Baseline, up to 2 months
Secondary outcomes (5)
Change in Overall Health Status
The SF-36 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993) will be used to evaluate eight scales that link to physical and mental health over a 4-week recall interval. This will reveal whether engaging in gardening activities will or will not result in changes in the overall health status based on instrument's physical and mental health subcomponent assessments of the gardening treatment group compared to the control group. The overall assessment scale for the SF-36 ranges from a low of 36 to a high of 400, with the U.S. norm being 314.
Measured: Baseline, up to 2 months
Change in Depressive Symptomatology
The study protocol will use the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988) with a recall interval of 2-weeks to gain insight relative to the intensity of depression. This assessment will determine whether engaging in gardening will or will not result in changes in depressive symptomatology of the gardening treatment group relative to the control group. The assessment scale for the Beck BDI ranges from a low of 10 to a high of 63. Scores 0-13 indicate minimal depressive symptomatology and above 19 up to 63 moderate to severe depressive symptomatology.
Measured: Baseline, up to 2 months
Change in State Anxiety
The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983) will be used in this study to gain insight regarding the relative intensity of anxiety being experienced by the gardening treatment group relative to the control group. The STAI reports on "at this moment" status. The STAI assessment will seek to determine whether engaging in gardening will or will not result in changes in State Anxiety status of the participants. The overall assessment scale for the STAI-Y ranges from a low of 20 to a high of 80, with higher scores indicating greater intensity of anxiety.
Measured: Baseline up to 2 months
Change in Mood States
The study protocol will employ the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS) with an immediate recall interval (McNair et al 1981; Shacham 1983) to gain insight of the relative to transient and fluctuating moods and enduring states of affect. The POMS2-AS will assess whether engaging in gardening activities will or will not result in changes in mood and enduring states of affect status of the gardening treatment group relative to the control group, both during and following the completion of the gardening activities treatment regimen. The assessment scale for the POMS2-AS ranges from 5 to a high of 100 per scale .
Measured: Baseline, up to 2 months
Change in Perceived Stress
The study will use the Perceived Stress Scale (PSS) (Cohen et al 1983) with a recall interval of 4-weeks to gain insight relative to the intensity of perceived stress. This assessment will determine whether engaging in gardening activities will or will not result in changes in the perceived stress levels of the gardening treatment group relative to the control group. The assessment scale for the Perceived Stress Scale ranges from a low of 0 to a high of 40, indicating higher stress at higher scores. The norm score for women is 13.7.
Measured: Baseline, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Foliage Foundation
- Responsible party
- Sponsor
- Investigators
- Charles L Guy, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225847
- Sponsor's protocol ID
- IRB201400425
- Status last verified
- May 2019
- First submitted
- 20 Aug 2014
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: At the completion of the study de-identified raw fMRI data from the study will be submitted to OpenfMRI, an open source fMRI database repository located at: https://openfmri.org/. De-identified processed datasets from the brain scans will be submitted to BrainMap or Neurosynth for open source access suitable for meta-analysis of processed fMRI data from brain imaging studies. The URL for BrainMap: http://www.brainmap.org/. The URL for Neurosynth is: http://www.neurosynth.org/.
Publications
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
PubMed 8275167Beck, AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review 1988 (8):77-100.
Spielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983
McNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.
Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.
PubMed 6886962Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gardening on Brain Activity
- ClinicalTrials.gov ID
- NCT02225847
- Acronym / sponsor ID
- IRB201400425
- Conditions
- Stress, Depression, Anxiety, Quality of Life
- Keywords
- Gardening, Therapeutic Horticulture, Functional Magnetic Resonance Imaging, Psychometric Assessment, Stress, Depression, Anxiety, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Foliage Foundation
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Aug 2014 (estimated)
- 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 objective of the research is to test the hypothesis that participating in group-based gardening activities alters brain network activation and function, and that such change occurring in the brain forms the neurobiological basis for much of the nonphysical activity portion of the therapeutic benefits of gardening and horticultural therapy. Assessment of the effects of the gardening activities on the experimental population will take two approaches, the first being the use of functional Magnetic Resonance Imaging (fMRI) to assess the regions of the brain that may become activated as a consequence of experiencing the cumulative gardening activities and associated stimuli. The allied approach will employ widely used and well-established self-reported assessment instruments that will capture information about the health and well-being that will then provide a psychometrically-based before and after physical and health summary of the participants in the control group and those engaged in the gardening activities.
Detailed description
The goal of this project is to better understand how interacting and working with plants in a group gardening activities program that takes place in a greenhouse effects patterns of brain activity and overall health and well-being. There has been essentially no assessment of the effects of gardening or engaging in gardening activities on brain activity using functional MRI (fMRI) approaches. This study will employ visual stimuli to assess the effects of the gardening activities treatment on Blood Oxygen Level Dependent (BOLD) responses as revealed by fMRI in study subjects in a comparison of responses before and after engaging in the gardening intervention program.
Specifically this study seeks to determine whether engaging in gardening activities taking place in a greenhouse can influence brain activity and function, and result in changes in overall quality of life status of subjects in a wellness population.
The total study population (N = 23) will consist of 11 healthy women in the control group, and 12 healthy women in the treatment group. There will be fMRI brain scans and psychometric pre- and post-intervention assessments administered to the study subjects. The fMRI and psychometric assessments will be administered within 10 days prior to the start of the intervention, and within 10 days following the completion of the treatment intervention. The control group will continue with normal daily life over a seven to eight week interval, and receive no other intervention. The treatment group will be divided into two groups of six women each that will receive the gardening intervention on different days of the week. The participants in the treatment group will receive an experimental intervention consisting of 12 gardening sessions, each approximately 60 minutes in duration over a six week treatment period. Each gardening session will take place at the same time of day twice each week, and follow a standardized programming sequence to ensure equivalency of intervention across all gardening sessions. Ambient environmental conditions in the greenhouse during the gardening sessions will be monitored and recorded. The gardening activities will emphasize growing plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste, visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a short educational module introducing the plants and gardening activities taking place during each session. In addition to the pre- and post-intervention assessments, psychometric assessments will be administered for depression and mood states at specific time points during the gardening activities to the treatment group to evaluate any changes over time resulting from the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Functional Magnetic Resonance Imaging (fMRI), Behavioral: psychometric assessmentsMembers of this group will continue with their daily life activities and will not receive gardening intervention. The control group will be given a set of psychometric assessments for health and quality of life evaluations and undergo a Functional Magnetic Resonance Imaging (fMRI) brain scan, followed by a second round of psychometric assessments and a fMRI brain scan administered seven to eight weeks after the initial baseline psychometric assessments and fMRI brain scan. |
| Gardening | Experimental | Other: Gardening, Procedure: Functional Magnetic Resonance Imaging (fMRI), Behavioral: psychometric assessmentsMembers of this group will be given a set of psychometric assessments for health and quality of life evaluations and a Functional Magnetic Resonance Imaging (fMRI) brain scan prior to receiving the gardening activities intervention. The gardening intervention will consist of twice weekly group sessions lasting 60 minutes in duration that will take place in a greenhouse. The duration of the experimental intervention will be six weeks for a total of 12 individual gardening activity sessions. Following the completion of the gardening intervention, a second round of psychometric assessments and a fMRI brain scan will be administered seven to eight weeks after the initial baseline psychometric assessments and fMRI brain scan. |
Who may qualify
- Ages
- 26 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Premenopausal women
- 26 - 49 years of age
- Not pregnant
- Non-gardener
- Non-smoker
Key exclusion criteria (7 listed)
- Uncomfortable in close spaces (claustrophobia)
- Allergies to plants
- Allergies to plant parts like pollen
- Allergies to plant-based foods
- No additions to alcohol or to recreational drugs or prescription medications
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 |
|---|---|---|
| GardeningThe intervention consists of twice weekly group sessions of gardening activities of 60 minutes in duration that will take place in a greenhouse. A total of 12 gardening sessions administered over a period of six weeks will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities. | Other | Gardening |
| Functional Magnetic Resonance Imaging (fMRI)Functional magnetic resonance imaging will be employed to assess whether engaging in gardening activities in a greenhouse does or does not alter the spatial patterns of brain network activation relative to changes that occur between the groups. | Procedure or surgery | Control, Gardening |
| psychometric assessmentsThe following assessments will be used: The SF-36 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993), the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988), The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983), the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS), and the Perceived Stress Scale (PSS) (Cohen et al 1983) for changes that occur in between the groups. | Behavioural | Control, Gardening |
Primary outcome
Change in Spatial Patterns of Brain Network Activation
Time frame: Baseline, up to 2 months
Functional magnetic resonance imaging will be employed to assess whether engaging in gardening activities in a greenhouse does or does not alter the spatial patterns of brain network activation relative to changes that occur in the control group.
5 secondary outcomes
Change in Overall Health Status
Time frame: Baseline, up to 2 months
Change in Depressive Symptomatology
Time frame: Baseline, up to 2 months
Change in State Anxiety
Time frame: Baseline up to 2 months
Change in Mood States
Time frame: Baseline, up to 2 months
Change in Perceived Stress
Time frame: Baseline, up to 2 months
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 23 May 2019.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 8275167Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
- BackgroundBeck, AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review 1988 (8):77-100.
- BackgroundSpielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983
- BackgroundMcNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.
- Background: PubMed 6886962Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Individual participant dataSharing planned: Yes. At the completion of the study de-identified raw fMRI data from the study will be submitted to OpenfMRI, an open source fMRI database repository located at: https://openfmri.org/. De-identified processed datasets from the brain scans will be submitted to BrainMap or Neurosynth for open source access suitable for meta-analysis of processed fMRI data from brain imaging studies. The URL for BrainMap: http://www.brainmap.org/. The URL for Neurosynth is: http://www.neurosynth.org/.
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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.
Charles L Guy, PhD principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gardening, Functional Magnetic Resonance Imaging (fMRI) and psychometric assessments in people with Stress and Depression, run by University of Florida at 3 sites in United States.
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 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Change in Spatial Patterns of Brain Network Activation (time frame: Baseline, up to 2 months). 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 NCT02225847, which also lists 7 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 23 May 2019.