StressNCT03489148
Implications of Tamarkoz® on Stress, Emotion, Spirituality and Heart Rate
A study testing Tamarkoz® and Stress management resources in people with Stress, run by Loma Linda University at 1 site in United States.
Trial summary
Depression, anxiety, hopelessness, poor sleep quality, somatic pain, high risk of substance abuse, and suicide ideation are positively correlated with perceived stress. Spirituality and positive emotions have profound, positive impacts on health and reduce perceived stress. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Tamarkoz® and Stress management resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2015to 4 Feb 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- University of California, Berkeley students between the ages of 18-30 years
Who cannot join
- work third shifts
- diabetes
- post-traumatic stress disorder
- liver disease
- autoimmune diseases
- severe depression that resists treatment or impacts ability to function
- schizophrenia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
Official title: Implications of Tamarkoz® on Reducing Stress and Heart Rate, and Increasing Positive Emotions, Spirituality
Depression, anxiety, hopelessness, poor sleep quality, somatic pain, high risk of substance abuse, and suicide ideation are positively correlated with perceived stress. Spirituality and positive emotions have profound, positive impacts on health and reduce perceived stress. The current study is an exploration of Tamarkoz®, a Sufi practice that is a method to concentrate, as a pathway by which spirituality and positive emotions effect perceived stress. Tamarkoz® incorporates physical, emotional, and spiritual aspects of an individual. In its current form, it includes Movazaneh® which is movement balancing developed by the Sufi Master, Professor Nader Angha. Movazaneh® movements direct concentration of the mind to a state of collectiveness and activates electromagnetic centers in the body, which are said to develop spirituality in an individual. A national survey of college students indicated that over 80% have interest in spiritual development.
Participants were recruited from the University of California, Berkeley for an 18-week quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the 38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus health center's stress management resources. Blood pressure and heart rate measurements were taken by the researcher using a validated home monitoring device. Additionally, all participants provided 3 diurnal saliva samples to determine changes in salivary immunoglobulin A and salivary cortisol. All data were collection was through non-evasive procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks.
Participants, diverse university students, had no prior exposure to Tamarkoz®.
Read the detailed description
This study is quasi-experimental, waitlist control group design with pretest-posttest. It consisted of three groups: (a) the intervention group who learned Tamarkoz® Sufi meditation practices, (b) a second group of students who utilized self-care stress management resources at the Tang University Health Services Center, and (c) a third group who was the waitlist control group who did not receive Tamarkoz® and did not use the stress management resources at the Tang Center for the duration of the study.
The design is represented in the following diagram. NR O(a) XT O(b) O(d) NR O(d) XS O(e) O(g) NR O(g) O(h) O(i)
XT represents twelve weeks of Tamarkoz® training and XS represents twelve weeks of Tang Center stress management techniques. Each O represents one of three measurements in each group: (a) at baseline, (b) 12 weeks later, immediately after the intervention ends, and (c) six weeks post-intervention. The intervention group met twice a week for two and a half hours total for three months. One day of the week, they met for theoretical teachings of Sufism, and for the second day in the week they met to learn Tamarkoz® techniques. The self-care stress management group used the campus resources for stress management as needed for themselves.
- Conditions
- Stress
- Being tested
- Tamarkoz®, Stress management resources
- Keywords
- Stress, Relaxation, Health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamarkoz®Behavioural
Tamarkoz® techniques includes six key elements: clearing the mind, breathing exercises, Movazeneh® (movement and balance exercises), deep relaxation, and visualization.
Stress management resourcesBehavioural
Use of the campus health center's stress management resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, pet-an-animal a week, and online reading material about self-care for stress management.
| Study group | Role | What they receive |
|---|---|---|
| Tamarkoz® | Experimental | A Sufi method to focus, called Tamarkoz®. Participants had met in class twice a week for two and a half hours total for three months. One day of the week, they met for theoretical teachings of Sufism, and for the second day in the week they met with a Tamarkoz® instructor to learn meditation techniques. Receives: Behavioral: Tamarkoz® |
| Stress Management Resources | Active comparator | The self-care stress management group used the campus resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, and online reading materials for stress management as needed for themselves. Receives: Behavioral: Stress management resources |
| Waitlist | No intervention | The waitlist control group did not receive Tamarkoz® and did not use the stress management resources on campus for the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress scale
The scale measures the degree to which one perceives situations in one's life as stressful on a Likert Scale of 0 to 4 with 0 indicating never, and 4 indicating very often. Higher scores indicate higher levels of perceived stress.
Measured: Change between baseline and 18 weeks
Secondary outcomes (1)
Salivary Immunoglobulin A (SIgA) in Saliva
Analysis of saliva drool analysis of salivary immunoglobbulin A immune cell. Lab will analyze the saliva. Normal levels of SIgA have not been determine.
Measured: Change between baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start24 Aug 2015
- Primary completion4 Feb 2016
- Study completion4 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were recruited from the University of California, Berkeley for an 18-week quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the 38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus health center's stress management resources. Blood pressure and heart rate measurements were taken by the researcher using a validated home monitoring device. Additionally, all participants provided 3 diurnal saliva samples to determine changes in salivary immunoglobulin A and salivary cortisol. All data were collection was through non-evasive procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Bahadorani, DrPH, Principal investigator, Loma Linda UniversityJerry W Lee, PhD, Study chair, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489148
- Sponsor's protocol ID
- 5150225
- Status last verified
- Apr 2018
- First submitted
- 4 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Largo-Wight E, Peterson PM, Chen WW. Perceived problem solving, stress, and health among college students. Am J Health Behav. 2005 Jul-Aug;29(4):360-70. doi: 10.5993/ajhb.29.4.8.
PubMed 16006233Bayram N, Bilgel N. The prevalence and socio-demographic correlations of depression, anxiety and stress among a group of university students. Soc Psychiatry Psychiatr Epidemiol. 2008 Aug;43(8):667-72. doi: 10.1007/s00127-008-0345-x. Epub 2008 Apr 8.
PubMed 18398558Devos, C., Boudrenghien, G., Van der Linden, N., Azzi, A., Frenay, M., Galand, B., & Klein, O. Doctoral students' experiences leading to completion or attrition: A matter of sense, progress and distress. European Journal of Psychology of Education: 1-17, 2016. doi:10.1007/s10212-016-0290-0
Romans, J. S. C., White, J. K., Harrist, R. S., Boswell, D. L., Sims, W. D., & Murn, L. T. Predicting attrition from counseling in a university counseling center sample using the Outcome Questionnaire-45.2. Internet Journal of Mental Health, 7(1), 1-8, 2011.
Lund HG, Reider BD, Whiting AB, Prichard JR. Sleep patterns and predictors of disturbed sleep in a large population of college students. J Adolesc Health. 2010 Feb;46(2):124-32. doi: 10.1016/j.jadohealth.2009.06.016. Epub 2009 Aug 3.
PubMed 20113918Kennedy C, Kassab O, Gilkey D, Linnel S, Morris D. Psychosocial factors and low back pain among college students. J Am Coll Health. 2008 Sep-Oct;57(2):191-5. doi: 10.3200/JACH.57.2.191-196.
PubMed 18809536Dixon, W. A., Rumford, K. G., Heppner, P. P., & Lips, B. J. Use of different sources of stress to predict hopelessness and suicide ideation in a college population. Journal of Counseling Psychology, 39(3), 342-349, 1992. doi:10.1037/0022-0167.39.3.342
Oman D, Shapiro SL, Thoresen CE, Plante TG, Flinders T. Meditation lowers stress and supports forgiveness among college students: a randomized controlled trial. J Am Coll Health. 2008 Mar-Apr;56(5):569-78. doi: 10.3200/JACH.56.5.569-578.
PubMed 18400671Mahmoud JS, Staten R, Hall LA, Lennie TA. The relationship among young adult college students' depression, anxiety, stress, demographics, life satisfaction, and coping styles. Issues Ment Health Nurs. 2012 Mar;33(3):149-56. doi: 10.3109/01612840.2011.632708.
PubMed 22364426O'Leary A. Stress, emotion, and human immune function. Psychol Bull. 1990 Nov;108(3):363-82. doi: 10.1037/0033-2909.108.3.363.
PubMed 2270233Herman L, Shtayermman O, Aksnes B, Anzalone M, Cormerais A, Liodice C. The use of prescription stimulants to enhance academic performance among college students in health care programs. J Physician Assist Educ. 2011;22(4):15-22. doi: 10.1097/01367895-201122040-00003.
PubMed 22308929Sawatzky RG, Ratner PA, Richardson CG, Washburn C, Sudmant W, Mirwaldt P. Stress and depression in students: the mediating role of stress management self-efficacy. Nurs Res. 2012 Jan-Feb;61(1):13-21. doi: 10.1097/NNR.0b013e31823b1440.
PubMed 22166906Taub, D. J., & Thompson, J. College Student Suicide. New Directions for Student Services, 2013(141), 5-14, 2013. doi:10.1002/ss.20036
Adams DR, Meyers SA, Beidas RS. The relationship between financial strain, perceived stress, psychological symptoms, and academic and social integration in undergraduate students. J Am Coll Health. 2016 Jul;64(5):362-70. doi: 10.1080/07448481.2016.1154559. Epub 2016 Mar 4.
PubMed 26943354DeRoma, V. M., Leach, J. B., & Leverett, J. P. The relationship between depression and college academic performance. College Student Journal, 43(2), 325-334, 2009
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Tamarkoz® on Reducing Stress and Heart Rate, and Increasing Positive Emotions, Spirituality
- ClinicalTrials.gov ID
- NCT03489148
- Acronym / sponsor ID
- 5150225
- Conditions
- Stress
- Keywords
- Stress, Relaxation, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 24 Aug 2015 (actual)
- Primary completion
- 4 Feb 2016 (actual)
- Study completion
- 4 Feb 2016 (actual)
- First posted
- 5 Apr 2018 (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.
Depression, anxiety, hopelessness, poor sleep quality, somatic pain, high risk of substance abuse, and suicide ideation are positively correlated with perceived stress. Spirituality and positive emotions have profound, positive impacts on health and reduce perceived stress. The current study is an exploration of Tamarkoz®, a Sufi practice that is a method to concentrate, as a pathway by which spirituality and positive emotions effect perceived stress. Tamarkoz® incorporates physical, emotional, and spiritual aspects of an individual. In its current form, it includes Movazaneh® which is movement balancing developed by the Sufi Master, Professor Nader Angha. Movazaneh® movements direct concentration of the mind to a state of collectiveness and activates electromagnetic centers in the body, which are said to develop spirituality in an individual. A national survey of college students indicated that over 80% have interest in spiritual development.
Participants were recruited from the University of California, Berkeley for an 18-week quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the 38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus health center's stress management resources. Blood pressure and heart rate measurements were taken by the researcher using a validated home monitoring device. Additionally, all participants provided 3 diurnal saliva samples to determine changes in salivary immunoglobulin A and salivary cortisol. All data were collection was through non-evasive procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks.
Participants, diverse university students, had no prior exposure to Tamarkoz®.
Detailed description
This study is quasi-experimental, waitlist control group design with pretest-posttest. It consisted of three groups: (a) the intervention group who learned Tamarkoz® Sufi meditation practices, (b) a second group of students who utilized self-care stress management resources at the Tang University Health Services Center, and (c) a third group who was the waitlist control group who did not receive Tamarkoz® and did not use the stress management resources at the Tang Center for the duration of the study.
The design is represented in the following diagram. NR O(a) XT O(b) O(d) NR O(d) XS O(e) O(g) NR O(g) O(h) O(i)
XT represents twelve weeks of Tamarkoz® training and XS represents twelve weeks of Tang Center stress management techniques. Each O represents one of three measurements in each group: (a) at baseline, (b) 12 weeks later, immediately after the intervention ends, and (c) six weeks post-intervention. The intervention group met twice a week for two and a half hours total for three months. One day of the week, they met for theoretical teachings of Sufism, and for the second day in the week they met to learn Tamarkoz® techniques. The self-care stress management group used the campus resources for stress management as needed for themselves.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Participants were recruited from the University of California, Berkeley for an 18-week quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the 38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus health center's stress management resources. Blood pressure and heart rate measurements were taken by the researcher using a validated home monitoring device. Additionally, all participants provided 3 diurnal saliva samples to determine changes in salivary immunoglobulin A and salivary cortisol. All data were collection was through non-evasive procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks.
| Arm | Type | Receives |
|---|---|---|
| Tamarkoz® | Experimental | Behavioral: Tamarkoz®A Sufi method to focus, called Tamarkoz®. Participants had met in class twice a week for two and a half hours total for three months. One day of the week, they met for theoretical teachings of Sufism, and for the second day in the week they met with a Tamarkoz® instructor to learn meditation techniques. |
| Stress Management Resources | Active comparator | Behavioral: Stress management resourcesThe self-care stress management group used the campus resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, and online reading materials for stress management as needed for themselves. |
| Waitlist | No intervention | –The waitlist control group did not receive Tamarkoz® and did not use the stress management resources on campus for the duration of the study. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- University of California, Berkeley students between the ages of 18-30 years
Key exclusion criteria (7 listed)
- work third shifts
- diabetes
- post-traumatic stress disorder
- liver disease
- autoimmune diseases
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 |
|---|---|---|
| Tamarkoz®Tamarkoz® techniques includes six key elements: clearing the mind, breathing exercises, Movazeneh® (movement and balance exercises), deep relaxation, and visualization. | Behavioural | Tamarkoz® |
| Stress management resourcesUse of the campus health center's stress management resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, pet-an-animal a week, and online reading material about self-care for stress management. | Behavioural | Stress Management Resources |
Primary outcome
Perceived stress scale
Time frame: Change between baseline and 18 weeks
The scale measures the degree to which one perceives situations in one's life as stressful on a Likert Scale of 0 to 4 with 0 indicating never, and 4 indicating very often. Higher scores indicate higher levels of perceived stress.
1 secondary outcome
Salivary Immunoglobulin A (SIgA) in Saliva
Time frame: Change between baseline and 18 weeks
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 5 Apr 2018.
- Background: PubMed 16006233Largo-Wight E, Peterson PM, Chen WW. Perceived problem solving, stress, and health among college students. Am J Health Behav. 2005 Jul-Aug;29(4):360-70. doi: 10.5993/ajhb.29.4.8.
- Background: PubMed 18398558Bayram N, Bilgel N. The prevalence and socio-demographic correlations of depression, anxiety and stress among a group of university students. Soc Psychiatry Psychiatr Epidemiol. 2008 Aug;43(8):667-72. doi: 10.1007/s00127-008-0345-x. Epub 2008 Apr 8.
- BackgroundDevos, C., Boudrenghien, G., Van der Linden, N., Azzi, A., Frenay, M., Galand, B., & Klein, O. Doctoral students' experiences leading to completion or attrition: A matter of sense, progress and distress. European Journal of Psychology of Education: 1-17, 2016. doi:10.1007/s10212-016-0290-0
- BackgroundRomans, J. S. C., White, J. K., Harrist, R. S., Boswell, D. L., Sims, W. D., & Murn, L. T. Predicting attrition from counseling in a university counseling center sample using the Outcome Questionnaire-45.2. Internet Journal of Mental Health, 7(1), 1-8, 2011.
- Background: PubMed 20113918Lund HG, Reider BD, Whiting AB, Prichard JR. Sleep patterns and predictors of disturbed sleep in a large population of college students. J Adolesc Health. 2010 Feb;46(2):124-32. doi: 10.1016/j.jadohealth.2009.06.016. Epub 2009 Aug 3.
- Background: PubMed 18809536Kennedy C, Kassab O, Gilkey D, Linnel S, Morris D. Psychosocial factors and low back pain among college students. J Am Coll Health. 2008 Sep-Oct;57(2):191-5. doi: 10.3200/JACH.57.2.191-196.
- BackgroundDixon, W. A., Rumford, K. G., Heppner, P. P., & Lips, B. J. Use of different sources of stress to predict hopelessness and suicide ideation in a college population. Journal of Counseling Psychology, 39(3), 342-349, 1992. doi:10.1037/0022-0167.39.3.342
- Background: PubMed 18400671Oman D, Shapiro SL, Thoresen CE, Plante TG, Flinders T. Meditation lowers stress and supports forgiveness among college students: a randomized controlled trial. J Am Coll Health. 2008 Mar-Apr;56(5):569-78. doi: 10.3200/JACH.56.5.569-578.
- Background: PubMed 22364426Mahmoud JS, Staten R, Hall LA, Lennie TA. The relationship among young adult college students' depression, anxiety, stress, demographics, life satisfaction, and coping styles. Issues Ment Health Nurs. 2012 Mar;33(3):149-56. doi: 10.3109/01612840.2011.632708.
- Background: PubMed 2270233O'Leary A. Stress, emotion, and human immune function. Psychol Bull. 1990 Nov;108(3):363-82. doi: 10.1037/0033-2909.108.3.363.
- Background: PubMed 22308929Herman L, Shtayermman O, Aksnes B, Anzalone M, Cormerais A, Liodice C. The use of prescription stimulants to enhance academic performance among college students in health care programs. J Physician Assist Educ. 2011;22(4):15-22. doi: 10.1097/01367895-201122040-00003.
- Background: PubMed 22166906Sawatzky RG, Ratner PA, Richardson CG, Washburn C, Sudmant W, Mirwaldt P. Stress and depression in students: the mediating role of stress management self-efficacy. Nurs Res. 2012 Jan-Feb;61(1):13-21. doi: 10.1097/NNR.0b013e31823b1440.
- M.T.O.®. (2016). Tamarkoz®Link provided by the sponsor.
- Higher Education Research Institute. (2007). The spiritual life of college students: A national study of college students' search for meaning and purposeLink provided by the sponsor.
- Smith, T. W., Hout, M., \& Marsden, P. V. (2013). General Social Survey, 1972-2012Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Nasim Bahadorani, DrPH principal investigator
Loma Linda University
Jerry W Lee, PhD study chair
Loma Linda 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 Tamarkoz® and Stress management resources in people with Stress, run by Loma Linda University at 1 site 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 1 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 5 Apr 2018. 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 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?
Perceived stress scale (time frame: Change between baseline and 18 weeks). 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 NCT03489148, which also lists 49 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 5 Apr 2018.