TonsillectomyNCT03931395
Honey Used as Adjunct Therapy to Tylenol for Post-Op Tonsillectomy Patients
A study testing Honey in people with Tonsillectomy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Tonsillectomies are the second most common surgery with over half a million procedures in the United States for 2006. Tonsillectomies are considered a painful surgical procedure performed on children resulting in pain and nausea/vomiting for up to 7 days postoperatively. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English-speaking families
- male or female
- 2-17 years old undergoing a routine tonsillectomy procedure.
- English speaking families in the waiting room whose children are having any type of surgery during the time period we are enrolling the tonsillectomy patients.
Who cannot join
- Subjects will be excluded for any of the following reasons: Any child undergoing or has already undergone a tonsillectomy who has a genetic syndrome or developmental disability (e.g., Trisomy 21, Angelman Syndrome, etc.) which could impact the course of postoperative pain management.
- Any child who has an allergy to honey.
- Non English speaking families.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Evaluation of Honey as Adjunct Therapy to Tylenol and Motrin in Treating Post-Operative Pain and Nausea Following Tonsillectomy
Tonsillectomies are the second most common surgery with over half a million procedures in the United States for 2006. Tonsillectomies are considered a painful surgical procedure performed on children resulting in pain and nausea/vomiting for up to 7 days postoperatively. Up until recently, doctors have been prescribing upwards of ten days' worth of opioid pain medication for children following tonsillectomies due to the high incidence of pain expected afterwards. Effective July 1st, 2018, new laws regarding opioid restrictions came into place that restricted doctor's abilities to write for more than three days' worth of opioid pain medication without having to fill out sizeable amounts of additional paperwork. This law was put in place to combat the ongoing opioid epidemic that plagues this country. What the investigators are left with for the treatment of pain following these procedures are simply Tylenol and Motrin with a limited amount of opioid. With this being considered a highly painful surgery with a difficult recovery, more options are needed to effectively treat pain and reduce the incidence of emergency room visits and phone calls to the clinic regarding pain control in the postoperative period.
Studies in Europe have shown that honey is an effective adjunct treatment option in the reduction of pain in pediatric postoperative tonsillectomies. These studies are few and far between and more research needs to be conducted to validate these claims particularly in the United States where research on this subject has been extremely limited. Further, the extent to which families and health care providers in the United States would be receptive to using honey for children's postoperative pain is unclear since honey is considered a complementary and alternative medicine (CAM) intervention.
- Conditions
- Tonsillectomy
- Being tested
- Honey, Standard of Care
- Keywords
- Honey, Pediatrics, Post-Operative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyDietary supplement
Will give patients and families included in the honey standard of care group 40 packets of hospital approved honey to implement in the tonsillectomy post-operative care of the child
Standard of CareOther
Patients will receive standard post operative medications per surgeon
| Study group | Role | What they receive |
|---|---|---|
| Honey Plus Standard of Care | Experimental | The Honey standard of care group will receive treatment as usual, alternating acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic, plus 1 tsp of honey with every dose of acetaminophen. The Honey standard of care group will receive the first dose of honey in the recovery room with the administration of acetaminophen and will be provided with honey upon discharge. Receives: Dietary Supplement: Honey; Other: Standard of Care |
| Standard of Care | Active comparator | The standard of care group will receive treatment as usual (alternating acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic). Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores as assessed by the Numerical Rating scale in participants who are given honey.
Parents will use the Numerical Rating scale to assess their Childs pain. The range is 0-10, 0=No pain and 10 = Worst pain ever. This scale is used for patients who are developmentally able (ages 9 and up)
Measured: Baseline to 3 weeks
Pain scores as assessed by the Wong-Baker FACES scale in participants who are given honey.
Parents will use the FACES pain scale. They will have the child choose between a range of faces that indicate a pain score of 0-10, 0 (a smiling face) = no pain and 10 (crying face) = worst pain ever. This scale is used for patients who are developmentally able (ages 3-9)
Measured: Baseline to 3 weeks
Pain scores as assessed by the FLACC scale in participants who are given honey.
Parents will use use the FLACC pain scale, 0 = No pain and 10 = Worst pain ever. This scale will be used in children who developmentally can not rate their own pain (ages 2 months to 7 years)
Measured: Baseline to 3 weeks
Pain scores as assessed by the Numerical Rating scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
Parents will use the numerical rating scale to assess their Childs pain. The range is 0-10, 0=No pain and 10 = Worst pain ever. This scale is used for patients who are developmentally able (ages 9 and up)
Measured: Baseline to 3 weeks
Pain scores as assessed by the Wong-Baker FACES scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
Parents will use the FACES pain scale. They will have the child choose between a range of faces that indicate a pain score of 0-10, 0 (a smiling face) = no pain and 10 (crying face) = worst pain ever. This scale is used for patients who are developmentally able (ages 3-9)
Measured: Baseline to 3 weeks
Pain scores as assessed by the FLACC scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
Parents will use use the FLACC pain scale, 0 = No pain and 10 = Worst pain ever. This scale will be used in children who developmentally can not rate their own pain (ages 2 months to 7 years)
Measured: Baseline to 3 weeks
Nausea scores as assessed by the baxter barf scale in participants who receive honey.
Parents will use the baxter barf scale by selecting or having their child select a face that represents nausea on a scale of 0 to 10, 0 = no nausea and 10 = actively vomiting.
Measured: Baseline to 3 weeks
Nausea scores as assessed by the baxter barf scale in participants who receive standard of care.
Parents will use the baxter barf scale by selecting or having their child select a face that represents nausea on a scale of 0 to 10, 0 = no nausea and 10 = actively vomiting.
Measured: Baseline to 3 weeks
Secondary outcomes (2)
Beliefs and receptiveness of patient families to complementary and alternative medicine (CAM) and use of honey.
Families will be given a CAM questionnaire to complete. The questionnaire asks families to rate on a scale of strongly disagree to strongly agree and asks questions like "The more knowledge a person has about CAM, the more likely they are to use it" and "There are less side effects when taking natural remedies" Families who select strongly disagree = they definitely do not agree with the statement. If they select strongly agree = they very much agree with the statement. Families will get this survey at the beginning of the study and get it again at the end to evaluate if their statement responses have changed.
The beliefs and attitudes toward CAM were measured based on a 7-point Likert scale, with 1 representing strongly agree and 7 representing strongly disagree; mean scores and standard deviation were calculated for each of the 13 items.
Measured: Baseline to 3 weeks
The relation between the beliefs and receptiveness of nursing staff to complementary and alternative medicine (CAM) and use of honey.
Nursing staff will receive a voluntary survey containing the CAM belief scale. The survey asks nurses to rate on a scale of Strongly disagree to Strongly agree and asks questions such as "I assess my patient for CAM use" or "I believe that CAM has a role in my practice." Strongly disagree = they definitely do not agree with the statement, strongly agree = They strongly agree with the statement.
The beliefs and attitudes toward CAM were measured based on a 7-point Likert scale, with 1 representing strongly agree and 7 representing strongly disagree; mean scores and standard deviation were calculated for each of the 13 items.
Measured: Baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start16 Apr 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Grierson, Vanderbilt University Medical Center
- Investigators
- Elizabeth Card, MSN, Study director, Nursing Research Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931395
- Sponsor's protocol ID
- 190013
- Status last verified
- Mar 2021
- First submitted
- 24 Apr 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaryszak EM, Lander L, Patel AK, Choi SS, Shah RK. Prolonged recovery after out-patient pediatric adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2011 Apr;75(4):585-8. doi: 10.1016/j.ijporl.2011.01.024. Epub 2011 Feb 15.
PubMed 21324535Ozlugedik S, Genc S, Unal A, Elhan AH, Tezer M, Titiz A. Can postoperative pains following tonsillectomy be relieved by honey? A prospective, randomized, placebo controlled preliminary study. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1929-34. doi: 10.1016/j.ijporl.2006.07.001. Epub 2006 Aug 17.
PubMed 16914210Boroumand P, Zamani MM, Saeedi M, Rouhbakhshfar O, Hosseini Motlagh SR, Aarabi Moghaddam F. Post tonsillectomy pain: can honey reduce the analgesic requirements? Anesth Pain Med. 2013 Summer;3(1):198-202. doi: 10.5812/aapm.9246. Epub 2013 Jul 1.
PubMed 24223362Bardy J, Slevin NJ, Mais KL, Molassiotis A. A systematic review of honey uses and its potential value within oncology care. J Clin Nurs. 2008 Oct;17(19):2604-23. doi: 10.1111/j.1365-2702.2008.02304.x.
PubMed 18808626Abdullah B, Lazim NM, Salim R. The effectiveness of Tualang honey in reducing post-tonsillectomy pain. Kulak Burun Bogaz Ihtis Derg. 2015;25(3):137-43. doi: 10.5606/kbbihtisas.2015.00008.
PubMed 26050853Mohebbi S, Nia FH, Kelantari F, Nejad SE, Hamedi Y, Abd R. Efficacy of honey in reduction of post tonsillectomy pain, randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1886-9. doi: 10.1016/j.ijporl.2014.08.018. Epub 2014 Aug 21.
PubMed 25193590Gedaly-Duff V, Ziebarth D. Mothers' management of adenoid-tonsillectomy pain in 4- to 8-year-olds: a preliminary study. Pain. 1994 Jun;57(3):293-299. doi: 10.1016/0304-3959(94)90004-3.
PubMed 7524009Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
PubMed 8867249Gabalski EC, Mattucci KF, Setzen M, Moleski P. Ambulatory tonsillectomy and adenoidectomy. Laryngoscope. 1996 Jan;106(1 Pt 1):77-80. doi: 10.1097/00005537-199601000-00015.
PubMed 8544633
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Honey as Adjunct Therapy to Tylenol and Motrin in Treating Post-Operative Pain and Nausea Following Tonsillectomy
- ClinicalTrials.gov ID
- NCT03931395
- Acronym / sponsor ID
- 190013
- Conditions
- Tonsillectomy
- Keywords
- Honey, Pediatrics, Post-Operative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 30 Apr 2019 (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.
Tonsillectomies are the second most common surgery with over half a million procedures in the United States for 2006. Tonsillectomies are considered a painful surgical procedure performed on children resulting in pain and nausea/vomiting for up to 7 days postoperatively. Up until recently, doctors have been prescribing upwards of ten days' worth of opioid pain medication for children following tonsillectomies due to the high incidence of pain expected afterwards. Effective July 1st, 2018, new laws regarding opioid restrictions came into place that restricted doctor's abilities to write for more than three days' worth of opioid pain medication without having to fill out sizeable amounts of additional paperwork. This law was put in place to combat the ongoing opioid epidemic that plagues this country. What the investigators are left with for the treatment of pain following these procedures are simply Tylenol and Motrin with a limited amount of opioid. With this being considered a highly painful surgery with a difficult recovery, more options are needed to effectively treat pain and reduce the incidence of emergency room visits and phone calls to the clinic regarding pain control in the postoperative period.
Studies in Europe have shown that honey is an effective adjunct treatment option in the reduction of pain in pediatric postoperative tonsillectomies. These studies are few and far between and more research needs to be conducted to validate these claims particularly in the United States where research on this subject has been extremely limited. Further, the extent to which families and health care providers in the United States would be receptive to using honey for children's postoperative pain is unclear since honey is considered a complementary and alternative medicine (CAM) intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honey Plus Standard of Care | Experimental | Dietary Supplement: Honey, Other: Standard of CareThe Honey standard of care group will receive treatment as usual, alternating acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic, plus 1 tsp of honey with every dose of acetaminophen. The Honey standard of care group will receive the first dose of honey in the recovery room with the administration of acetaminophen and will be provided with honey upon discharge. |
| Standard of Care | Active comparator | Other: Standard of CareThe standard of care group will receive treatment as usual (alternating acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- English-speaking families
- male or female
- 2-17 years old undergoing a routine tonsillectomy procedure.
- English speaking families in the waiting room whose children are having any type of surgery during the time period we are enrolling the tonsillectomy patients.
Key exclusion criteria (3 listed)
- Subjects will be excluded for any of the following reasons: Any child undergoing or has already undergone a tonsillectomy who has a genetic syndrome or developmental disability (e.g., Trisomy 21, Angelman Syndrome, etc.) which could impact the course of postoperative pain management.
- Any child who has an allergy to honey.
- Non English speaking families.
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 |
|---|---|---|
| HoneyWill give patients and families included in the honey standard of care group 40 packets of hospital approved honey to implement in the tonsillectomy post-operative care of the child | Dietary supplement | Honey Plus Standard of Care |
| Standard of CarePatients will receive standard post operative medications per surgeon | Other | Honey Plus Standard of Care, Standard of Care |
Primary outcome
Pain scores as assessed by the Numerical Rating scale in participants who are given honey.
Time frame: Baseline to 3 weeks
Parents will use the Numerical Rating scale to assess their Childs pain. The range is 0-10, 0=No pain and 10 = Worst pain ever. This scale is used for patients who are developmentally able (ages 9 and up)
Pain scores as assessed by the Wong-Baker FACES scale in participants who are given honey.
Time frame: Baseline to 3 weeks
Parents will use the FACES pain scale. They will have the child choose between a range of faces that indicate a pain score of 0-10, 0 (a smiling face) = no pain and 10 (crying face) = worst pain ever. This scale is used for patients who are developmentally able (ages 3-9)
Pain scores as assessed by the FLACC scale in participants who are given honey.
Time frame: Baseline to 3 weeks
Parents will use use the FLACC pain scale, 0 = No pain and 10 = Worst pain ever. This scale will be used in children who developmentally can not rate their own pain (ages 2 months to 7 years)
Pain scores as assessed by the Numerical Rating scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
Time frame: Baseline to 3 weeks
Parents will use the numerical rating scale to assess their Childs pain. The range is 0-10, 0=No pain and 10 = Worst pain ever. This scale is used for patients who are developmentally able (ages 9 and up)
Pain scores as assessed by the Wong-Baker FACES scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
Time frame: Baseline to 3 weeks
Parents will use the FACES pain scale. They will have the child choose between a range of faces that indicate a pain score of 0-10, 0 (a smiling face) = no pain and 10 (crying face) = worst pain ever. This scale is used for patients who are developmentally able (ages 3-9)
Pain scores as assessed by the FLACC scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
Time frame: Baseline to 3 weeks
Parents will use use the FLACC pain scale, 0 = No pain and 10 = Worst pain ever. This scale will be used in children who developmentally can not rate their own pain (ages 2 months to 7 years)
Nausea scores as assessed by the baxter barf scale in participants who receive honey.
Time frame: Baseline to 3 weeks
Parents will use the baxter barf scale by selecting or having their child select a face that represents nausea on a scale of 0 to 10, 0 = no nausea and 10 = actively vomiting.
Nausea scores as assessed by the baxter barf scale in participants who receive standard of care.
Time frame: Baseline to 3 weeks
Parents will use the baxter barf scale by selecting or having their child select a face that represents nausea on a scale of 0 to 10, 0 = no nausea and 10 = actively vomiting.
2 secondary outcomes
Beliefs and receptiveness of patient families to complementary and alternative medicine (CAM) and use of honey.
Time frame: Baseline to 3 weeks
The relation between the beliefs and receptiveness of nursing staff to complementary and alternative medicine (CAM) and use of honey.
Time frame: Baseline to 3 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 1 Apr 2021.
- Background: PubMed 21324535Jaryszak EM, Lander L, Patel AK, Choi SS, Shah RK. Prolonged recovery after out-patient pediatric adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2011 Apr;75(4):585-8. doi: 10.1016/j.ijporl.2011.01.024. Epub 2011 Feb 15.
- Background: PubMed 16914210Ozlugedik S, Genc S, Unal A, Elhan AH, Tezer M, Titiz A. Can postoperative pains following tonsillectomy be relieved by honey? A prospective, randomized, placebo controlled preliminary study. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1929-34. doi: 10.1016/j.ijporl.2006.07.001. Epub 2006 Aug 17.
- Background: PubMed 24223362Boroumand P, Zamani MM, Saeedi M, Rouhbakhshfar O, Hosseini Motlagh SR, Aarabi Moghaddam F. Post tonsillectomy pain: can honey reduce the analgesic requirements? Anesth Pain Med. 2013 Summer;3(1):198-202. doi: 10.5812/aapm.9246. Epub 2013 Jul 1.
- Background: PubMed 18808626Bardy J, Slevin NJ, Mais KL, Molassiotis A. A systematic review of honey uses and its potential value within oncology care. J Clin Nurs. 2008 Oct;17(19):2604-23. doi: 10.1111/j.1365-2702.2008.02304.x.
- Background: PubMed 26050853Abdullah B, Lazim NM, Salim R. The effectiveness of Tualang honey in reducing post-tonsillectomy pain. Kulak Burun Bogaz Ihtis Derg. 2015;25(3):137-43. doi: 10.5606/kbbihtisas.2015.00008.
- Background: PubMed 25193590Mohebbi S, Nia FH, Kelantari F, Nejad SE, Hamedi Y, Abd R. Efficacy of honey in reduction of post tonsillectomy pain, randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1886-9. doi: 10.1016/j.ijporl.2014.08.018. Epub 2014 Aug 21.
- Background: PubMed 7524009Gedaly-Duff V, Ziebarth D. Mothers' management of adenoid-tonsillectomy pain in 4- to 8-year-olds: a preliminary study. Pain. 1994 Jun;57(3):293-299. doi: 10.1016/0304-3959(94)90004-3.
- Background: PubMed 8867249Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
- Background: PubMed 8544633Gabalski EC, Mattucci KF, Setzen M, Moleski P. Ambulatory tonsillectomy and adenoidectomy. Laryngoscope. 1996 Jan;106(1 Pt 1):77-80. doi: 10.1097/00005537-199601000-00015.
- 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.
Elizabeth Card, MSN study director
Nursing Research Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey in people with Tonsillectomy, run by Vanderbilt University Medical Center 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 4 inclusion and 3 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 1 Apr 2021. 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?
Pain scores as assessed by the Numerical Rating scale in participants who are given honey. (time frame: Baseline to 3 weeks). The study lists 8 primary outcomes in all. 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 NCT03931395, which also lists 9 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 1 Apr 2021.