Functional Gastrointestinal DisordersNCT05948215

Jing Si Herbal Tea in the Treatment of Dyspeptic Symptoms

A study testing Jing Si Herbal Tea Liquid Packet in people with Functional Gastrointestinal Disorders and Healthy Subjects, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Functional Gastrointestinal Disorders, Healthy Subjects
What is being tested?: Jing Si Herbal Tea Liquid Packet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteTaiwan
Study dates: 1 Jan 2021to 31 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 20 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age between 20-79 years old.
Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia (FD) is chronic (once a week, lasting at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following): postprandial abdominal distension, easy to feel full, Epigastric pain or burning sensation in the upper abdomen, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy).
Be conscious and willing to sign the subject's consent form.

Who cannot join

Abnormal liver and kidney function;
Abnormal blood tests and thyroid abnormalities;
Have received surgery on the digestive tract;
Abnormal upper gastrointestinal endoscopy;
Have gastric pylori infection;
Antibiotics are being used for infectious diseases;

Show all 9Show fewer

Pregnant or breastfeeding women;
Suffering from heart, liver, or kidney failure;
Physical weakness, allergies, coldness, chronic diseases, poor kidney function, infants under three years old, children, Pregnancy, lactation, menstrual period.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Hualien Tzu Chi Hospital
Hualien City, 970

Other trials in Taiwan

About this study

Official title: Jing Si Herbal Tea in the Treatment of Dyspeptic Symptoms and Psychophysical Burden in Patients With Functional dyspepsia--a Double-blind, Randomized, Placebo-controlled Study

Dyspepsia refers to chronic or recurrent upper gastrointestinal symptoms. According to the Rome IV criteria, functional dyspepsia (FD) symptoms included meal-related fullness, early satiation, epigastric pain or burning which are unexplained after routine investigation. FD causes substantial psychophysical burden because of its unknown etiology and high prevalence. Although FD is currently associated with local inflammation of the gastrointestinal tract and microbiota alteration, current available treatments for FD are of limited effectiveness. In view of this, many studies have applied Chinese herbal medicine in FD and achieved some therapeutic benefit. The Jing Si Herbal Tea composed of eight native Taiwanese herbs (wormwood, hickory grass, Ophiopogon japonicus, houttuynia cordata, platycodon, licorice, perilla leaves, chrysanthemum) has obtained a special export license from the Ministry of Health and Welfare. The Jing Si Herbal Tea also has been registered in clinical trials as a complementary treatment for COVID-19. The preliminary data demonstrated that the Jing Si Herbal Tea may improve gastrointestinal symptoms and anxiety in patients with COVID-19. Therefore, this study aims to investigate the impact of the Jing Si Herbal Tea on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.

Conditions: Functional Gastrointestinal Disorders, Healthy Subjects
Being tested: Jing Si Herbal Tea Liquid Packet, Jing Si Herbal Tea Liquid Packet Placebo
Keywords: Jing Si Herbal Tea Liquid Packet, psychophysical burden
Medical subject headings: Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Jing Si Herbal Tea Liquid PacketDietary supplement
The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with Coronavirus disease 2019(COVID-19). Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.
Jing Si Herbal Tea Liquid Packet PlaceboDietary supplement
Also called Placebo
Compared with the improvement effect of Jing Si Herbal Tea Liquid Packet, to avoid participants thinking that the improvement is due to psychological effects.

Study groups in NCT05948215
Study group	Role	What they receive
Jing Si Herbal Tea Liquid Packet	Experimental	Participants received Jing Si Herbal Tea Liquid Packet 15 mg tablet orally once daily for 28 days. Receives: Dietary Supplement: Jing Si Herbal Tea Liquid Packet
Jing Si Herbal Tea Liquid Packet Placebo	Placebo comparator	Participants received Jing Si Herbal Tea Liquid Packet Placebo 15 mg tablet orally once daily for 28 days. Receives: Dietary Supplement: Jing Si Herbal Tea Liquid Packet Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28
Possible scores range from 0 (No pain) to 10 (Worst possible pain) Change = (day 28 Score - Baseline Score).
Measured: Baseline and day 28
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at day 28
Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 28 Score - Baseline Score).
Measured: Baseline and day 28
Change from Baseline on the Taiwanese Depression Scale (TDQ) at day 28
Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 28 Score - Baseline Score).
Measured: Baseline and day 28
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at day 28
Possible scores range from 1 (Never) to 4 (Always)
1=Never 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Measured: Baseline and day 28
Change from Baseline on the Perceived Stress Scale(PSS-10) at day 28
Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Measured: Baseline and day 28
Change from Baseline on the Patient Assessment of Upper Gastrointestinal Symptoms(PAGI-SYM) at day 28
Possible scores range from 0 (No pain) to 5 (Very serious) 0=No pain 1=Very slightly 2=Slight 3=About medium 4=Serious 5=Very serious Change = (day 28 Score - Baseline Score).
Measured: Baseline and day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202131 Dec 2021

First posted17 Jul 2023
Study start1 Jan 2021
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05948215
Sponsor's protocol ID: IRB110-232-A
Status last verified: Jun 2023
First submitted: 5 Jul 2023
Last updated: 17 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sperber AD, Bangdiwala SI, Drossman DA, Ghoshal UC, Simren M, Tack J, Whitehead WE, Dumitrascu DL, Fang X, Fukudo S, Kellow J, Okeke E, Quigley EMM, Schmulson M, Whorwell P, Archampong T, Adibi P, Andresen V, Benninga MA, Bonaz B, Bor S, Fernandez LB, Choi SC, Corazziari ES, Francisconi C, Hani A, Lazebnik L, Lee YY, Mulak A, Rahman MM, Santos J, Setshedi M, Syam AF, Vanner S, Wong RK, Lopez-Colombo A, Costa V, Dickman R, Kanazawa M, Keshteli AH, Khatun R, Maleki I, Poitras P, Pratap N, Stefanyuk O, Thomson S, Zeevenhooven J, Palsson OS. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021 Jan;160(1):99-114.e3. doi: 10.1053/j.gastro.2020.04.014. Epub 2020 Apr 12.
PubMed 32294476
Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011.
PubMed 27147122
Talley NJ, Ford AC. Functional Dyspepsia. N Engl J Med. 2015 Nov 5;373(19):1853-63. doi: 10.1056/NEJMra1501505. No abstract available.
PubMed 26535514
Wauters L, Talley NJ, Walker MM, Tack J, Vanuytsel T. Novel concepts in the pathophysiology and treatment of functional dyspepsia. Gut. 2020 Mar;69(3):591-600. doi: 10.1136/gutjnl-2019-318536. Epub 2019 Nov 29.
PubMed 31784469
Gwee KA, Holtmann G, Tack J, Suzuki H, Liu J, Xiao Y, Chen MH, Hou X, Wu DC, Toh C, Lu F, Tang XD. Herbal medicines in functional dyspepsia-Untapped opportunities not without risks. Neurogastroenterol Motil. 2021 Feb;33(2):e14044. doi: 10.1111/nmo.14044. Epub 2020 Nov 30.
PubMed 33258198
Masuy I, Van Oudenhove L, Tack J. Review article: treatment options for functional dyspepsia. Aliment Pharmacol Ther. 2019 May;49(9):1134-1172. doi: 10.1111/apt.15191. Epub 2019 Mar 28.
PubMed 30924176
Ford AC, Moayyedi P, Black CJ, Yuan Y, Veettil SK, Mahadeva S, Kengkla K, Chaiyakunapruk N, Lee YY. Systematic review and network meta-analysis: efficacy of drugs for functional dyspepsia. Aliment Pharmacol Ther. 2021 Jan;53(1):8-21. doi: 10.1111/apt.16072. Epub 2020 Sep 16.
PubMed 32936964
Teschke R, Wolff A, Frenzel C, Eickhoff A, Schulze J. Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders. World J Gastroenterol. 2015 Apr 21;21(15):4466-90. doi: 10.3748/wjg.v21.i15.4466.
PubMed 25914456
Suzuki H, Matsuzaki J, Fukushima Y, Suzaki F, Kasugai K, Nishizawa T, Naito Y, Hayakawa T, Kamiya T, Andoh T, Yoshida H, Tokura Y, Nagata H, Kobayakawa M, Mori M, Kato K, Hosoda H, Takebayashi T, Miura S, Uemura N, Joh T, Hibi T, Tack J; Rikkunshito study group. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia--a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterol Motil. 2014 Jul;26(7):950-61. doi: 10.1111/nmo.12348. Epub 2014 Apr 28.
PubMed 24766295
Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.
PubMed 27144617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Jing Si Herbal Tea in the Treatment of Dyspeptic Symptoms and Psychophysical Burden in Patients With Functional dyspepsia--a Double-blind, Randomized, Placebo-controlled Study
ClinicalTrials.gov ID: NCT05948215
Acronym / sponsor ID: IRB110-232-A
Conditions: Functional Gastrointestinal Disorders, Healthy Subjects
Keywords: Jing Si Herbal Tea Liquid Packet, psychophysical burden
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Buddhist Tzu Chi General HospitalUniversity, hospital or other
Study start: 1 Jan 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 17 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Jing Si Herbal Tea Liquid Packet	Experimental	Dietary Supplement: Jing Si Herbal Tea Liquid PacketParticipants received Jing Si Herbal Tea Liquid Packet 15 mg tablet orally once daily for 28 days.
Jing Si Herbal Tea Liquid Packet Placebo	Placebo comparator	Dietary Supplement: Jing Si Herbal Tea Liquid Packet PlaceboParticipants received Jing Si Herbal Tea Liquid Packet Placebo 15 mg tablet orally once daily for 28 days.

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age between 20-79 years old.
Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia (FD) is chronic (once a week, lasting at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following): postprandial abdominal distension, easy to feel full, Epigastric pain or burning sensation in the upper abdomen, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy).
Be conscious and willing to sign the subject's consent form.

Key exclusion criteria (9 listed)

Abnormal liver and kidney function;
Abnormal blood tests and thyroid abnormalities;
Have received surgery on the digestive tract;
Abnormal upper gastrointestinal endoscopy;
Have gastric pylori infection;

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
Jing Si Herbal Tea Liquid PacketThe preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with Coronavirus disease 2019(COVID-19). Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.	Dietary supplement	Jing Si Herbal Tea Liquid Packet
Jing Si Herbal Tea Liquid Packet PlaceboAlso: PlaceboCompared with the improvement effect of Jing Si Herbal Tea Liquid Packet, to avoid participants thinking that the improvement is due to psychological effects.	Dietary supplement	Jing Si Herbal Tea Liquid Packet Placebo

Primary outcome

Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28
Time frame: Baseline and day 28
Possible scores range from 0 (No pain) to 10 (Worst possible pain) Change = (day 28 Score - Baseline Score).
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at day 28
Time frame: Baseline and day 28
Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 28 Score - Baseline Score).
Change from Baseline on the Taiwanese Depression Scale (TDQ) at day 28
Time frame: Baseline and day 28
Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 28 Score - Baseline Score).
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at day 28
Time frame: Baseline and day 28
Possible scores range from 1 (Never) to 4 (Always) 1=Never 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Change from Baseline on the Perceived Stress Scale(PSS-10) at day 28
Time frame: Baseline and day 28
Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Change from Baseline on the Patient Assessment of Upper Gastrointestinal Symptoms(PAGI-SYM) at day 28
Time frame: Baseline and day 28
Possible scores range from 0 (No pain) to 5 (Very serious) 0=No pain 1=Very slightly 2=Slight 3=About medium 4=Serious 5=Very serious Change = (day 28 Score - Baseline Score).

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 17 Jul 2023.
Results publication: PubMed 32294476Sperber AD, Bangdiwala SI, Drossman DA, Ghoshal UC, Simren M, Tack J, Whitehead WE, Dumitrascu DL, Fang X, Fukudo S, Kellow J, Okeke E, Quigley EMM, Schmulson M, Whorwell P, Archampong T, Adibi P, Andresen V, Benninga MA, Bonaz B, Bor S, Fernandez LB, Choi SC, Corazziari ES, Francisconi C, Hani A, Lazebnik L, Lee YY, Mulak A, Rahman MM, Santos J, Setshedi M, Syam AF, Vanner S, Wong RK, Lopez-Colombo A, Costa V, Dickman R, Kanazawa M, Keshteli AH, Khatun R, Maleki I, Poitras P, Pratap N, Stefanyuk O, Thomson S, Zeevenhooven J, Palsson OS. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021 Jan;160(1):99-114.e3. doi: 10.1053/j.gastro.2020.04.014. Epub 2020 Apr 12.
Results publication: PubMed 27147122Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011.
Results publication: PubMed 26535514Talley NJ, Ford AC. Functional Dyspepsia. N Engl J Med. 2015 Nov 5;373(19):1853-63. doi: 10.1056/NEJMra1501505. No abstract available.
Results publication: PubMed 31784469Wauters L, Talley NJ, Walker MM, Tack J, Vanuytsel T. Novel concepts in the pathophysiology and treatment of functional dyspepsia. Gut. 2020 Mar;69(3):591-600. doi: 10.1136/gutjnl-2019-318536. Epub 2019 Nov 29.
Results publication: PubMed 33258198Gwee KA, Holtmann G, Tack J, Suzuki H, Liu J, Xiao Y, Chen MH, Hou X, Wu DC, Toh C, Lu F, Tang XD. Herbal medicines in functional dyspepsia-Untapped opportunities not without risks. Neurogastroenterol Motil. 2021 Feb;33(2):e14044. doi: 10.1111/nmo.14044. Epub 2020 Nov 30.
Results publication: PubMed 30924176Masuy I, Van Oudenhove L, Tack J. Review article: treatment options for functional dyspepsia. Aliment Pharmacol Ther. 2019 May;49(9):1134-1172. doi: 10.1111/apt.15191. Epub 2019 Mar 28.
Results publication: PubMed 32936964Ford AC, Moayyedi P, Black CJ, Yuan Y, Veettil SK, Mahadeva S, Kengkla K, Chaiyakunapruk N, Lee YY. Systematic review and network meta-analysis: efficacy of drugs for functional dyspepsia. Aliment Pharmacol Ther. 2021 Jan;53(1):8-21. doi: 10.1111/apt.16072. Epub 2020 Sep 16.
Results publication: PubMed 25914456Teschke R, Wolff A, Frenzel C, Eickhoff A, Schulze J. Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders. World J Gastroenterol. 2015 Apr 21;21(15):4466-90. doi: 10.3748/wjg.v21.i15.4466.
Results publication: PubMed 24766295Suzuki H, Matsuzaki J, Fukushima Y, Suzaki F, Kasugai K, Nishizawa T, Naito Y, Hayakawa T, Kamiya T, Andoh T, Yoshida H, Tokura Y, Nagata H, Kobayakawa M, Mori M, Kato K, Hosoda H, Takebayashi T, Miura S, Uemura N, Joh T, Hibi T, Tack J; Rikkunshito study group. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia--a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterol Motil. 2014 Jul;26(7):950-61. doi: 10.1111/nmo.12348. Epub 2014 Apr 28.
Results publication: PubMed 27144617Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Jing Si Herbal Tea Liquid Packet in people with Functional Gastrointestinal Disorders and Healthy Subjects, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.

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 3 inclusion and 9 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 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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. Some participants in this study may receive a placebo. 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 from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28 (time frame: Baseline and day 28). The study lists 6 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 NCT05948215, which also lists 10 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 17 Jul 2023.