Oral DiseasesPHoralNCT04295525
Carnosine Supplementation on Quantity/Quality of Oral Salivae.
A study testing 400 mg mucoadhesive oral tablet in people with Oral Diseases, run by University of Milan at 1 site in Italy.
Trial summary
The aim of this study is to elucidate the mutual relationship between salivae characteristics and oral microbiome and to compare them with common oral disease; furthermore, by using specific bioinformatic tools to analyse the data, the potentials of Carnosine in preventing/treating oral diseases and its mechanism of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Diseases
- What is being tested?
- 400 mg mucoadhesive oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 1 Dec 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- dental erosions (De)
- caries (Ca)
- périodontopathies (Pe)
Who cannot join
- allergies/intolerances to the consumption of Carnosine
- taking other food supplements
- any type of drug treatment (interview)
- smoking
- pregnancy/lactation
- any systemic diseases such as cardiovascular and respiratory, diabetes mellitus, HIV infection, or inflammatory conditions causing non-plaque dependent OD.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical, Surgical, and Dental Sciences, Istituto Stomatologico Italiano, Aesthetic Dentistry, School of Dentistry, University of Milan, Milan, Italy.
Milan, 20122
Dino Re
About this study
Official title: PHoral: Effects of Carnosine Supplementation on Quantity/Quality of Oral Salivae in Healthy Volunteer and in Subjects Affected by Common Oral Pathologies.
The aim of this study is to elucidate the mutual relationship between salivae characteristics and oral microbiome and to compare them with common oral disease; furthermore, by using specific bioinformatic tools to analyse the data, the potentials of Carnosine in preventing/treating oral diseases and its mechanism of action will be addressed by using quantitative proteomics.
Read the detailed description
The pH of the oral cavity is a synthetic parameter that underlies a multifactorial process of continuous adjustment that includes the effect of salivae as a buffer and the contribution of the oral cavity microbiome. In some diseases of the oral cavity an alteration of these adjustment mechanisms is supposed to alter the normal flow of salivae and, consequently, the pH and the oral microbiome with the expansion of potentially pathogenic strains such as e.g. streptococcus viridans.
Carnosine (Car) is an endogenous dipeptide, composed of β-alanine and L-histidine, that was originally discovered in larger amounts in skeletal muscle of some vertebrates, including humans, showing a greater dependence on non-oxidative forms of energy metabolism. This peculiar association with muscular tissue and its pH-buffering properties has led to associate Car with the intracellular acid-base homeostasis of muscles. More recently, the physiological role of Car has been expanded beyond the intracellular buffering properties, supporting a role in sarcoplasmic Ca2+ regulation and neutralisation of reactive oxygen species (ROS). It is well known that ROS induce the formation of reactive electrophilic carbonyl species by reacting with lipids and sugars which, in turn, react with proteins forming irreversible adducts (AGEs, ALEs and EAGLEs) and cross-links that may affect the cardiovascular wall matrix that becomes less distensible, especially during the ageing process and/or diseases. Thus it is thought that Car and, indeed, other histidine-containing peptide (HCD), may prevent chronic diseases via their anti-inflammatory, anti-oxidative, anti-glycating, anti-ischaemic and chelating properties. Furthermore, the localisation of Car in other tissues such as brain, olfactory bulb, heart, stomach, pancreas, kidney has suggested further potential uses in preventing e.g. neurodegenerative disorder and cognitive function or the development of type II diabetes.
The oral microbiome (OM) is a relevant part of the whole human MO since it contains several different niches, with distinct microbial communities, colonising the oral cavity (OC), including not only bacteria but also fungi, viruses, archaea and protozoa. These communities form a complex ecological system that influences OC and systemic health. Indeed the prevalent oral diseases (OD), namely dental caries and periodontal diseases, are believed to be microbiota-related. Furthermore, several evidences support the theory that many systemic diseases are associated with an altered OM, among these the most frequently associated diseases are metabolic, such as diabetes, cardiovascular and oncological ones. For their prevalence worldwide, among OD, periodontal infection, including gingivitis and chronic periodontitis, is possibly the most prevalent human microbial diseases (HMD).
In order to protect the OC from HMD, in the present project Car has been chosen as a possible preventive and/or therapeutic principle for its aforementioned multiple biological effects. Thus the safety and efficacy of AqualiefTM (Metis Healthcare s.r.l., Milano, Italy) a 400 mg mucoadhesive oral tablet (13 x 4 mm), that recognise Car as main ingredient, will be tested on healthy volunteer and in subjects affected by common OD.
The main objectives of this protocol are to estimate the quantity/quality of oral salivae and OM in healthy volunteer and in patients affected by common OD, before and after 7 days of treatment with AqualiefTM, 1 tablet twice. The characteristics of oral salivae (Sal) that will be studied are:
a - unstimulated and stimulated (paraffin-activated) salivary flow rates, pH and buffering power; b - quantitative proteomics (QP), on selected targets, representing the main metabolites/components of OM.
By matching Sal characteristics with OM and comparing them with OD, it is expected to elucidate their mutual relationship; furthermore, by using specific bioinformatic tools to analyse the data, the potentials of Car in preventing/treating OD and its mechanism of action will be addressed by using QP.
The study will take place at the Odontoiatric University Clinic (OUC), Istituto Stomatologico Italiano (ISI) of Milan, Italy, in a prospective, randomised, double-blind, placebo-controlled fashion.
- Conditions
- Oral Diseases
- Being tested
- 400 mg mucoadhesive oral tablet, placebo mucoadhesive oral tablet
- Keywords
- dental erosions, caries, périodontopathies
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg mucoadhesive oral tabletDietary supplement
AqualiefTM (Metis Healthcare s.r.l., Milano, Italy)
placebo mucoadhesive oral tabletDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| Controls subjects placebo | Placebo comparator | Placebo mucoadhesive oral tablet Receives: Dietary Supplement: placebo mucoadhesive oral tablet |
| Controls subjects active Treatment | Experimental | AqualiefTM 400 mg mucoadhesive oral tablet Receives: Dietary Supplement: 400 mg mucoadhesive oral tablet |
| Diseased subjects placebo | Placebo comparator | Placebo mucoadhesive oral tablet Receives: Dietary Supplement: placebo mucoadhesive oral tablet |
| Diseased subjects active Treatment | Experimental | AqualiefTM 400 mg mucoadhesive oral tablet Receives: Dietary Supplement: 400 mg mucoadhesive oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on oral pH.
Any change of oral pH from basal.
Measured: 7 days
Saliva Production unstimulated.
Change of oral saliva production, unstimulated.
Measured: 7 days
Saliva Production stimulated.
Change of oral saliva production, stimulated.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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 Oral DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Ciulla, University of Milan
- Investigators
- Michele Ciulla, MD, Principal investigator, Lab. Clin. Informatics & Cardiovascular Imaging, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295525
- Sponsor's protocol ID
- P0A.20.20
- Acronym
- PHoral
- Status last verified
- May 2022
- First submitted
- 26 Feb 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Almeida Pdel V, Gregio AM, Machado MA, de Lima AA, Azevedo LR. Saliva composition and functions: a comprehensive review. J Contemp Dent Pract. 2008 Mar 1;9(3):72-80.
PubMed 18335122Marsh PD, Do T, Beighton D, Devine DA. Influence of saliva on the oral microbiota. Periodontol 2000. 2016 Feb;70(1):80-92. doi: 10.1111/prd.12098.
PubMed 26662484Grassl N, Kulak NA, Pichler G, Geyer PE, Jung J, Schubert S, Sinitcyn P, Cox J, Mann M. Ultra-deep and quantitative saliva proteome reveals dynamics of the oral microbiome. Genome Med. 2016 Apr 21;8(1):44. doi: 10.1186/s13073-016-0293-0.
PubMed 27102203Abranches J, Zeng L, Kajfasz JK, Palmer SR, Chakraborty B, Wen ZT, Richards VP, Brady LJ, Lemos JA. Biology of Oral Streptococci. Microbiol Spectr. 2018 Oct;6(5):10.1128/microbiolspec.gpp3-0042-2018. doi: 10.1128/microbiolspec.GPP3-0042-2018.
PubMed 30338752Dolan E, Saunders B, Harris RC, Bicudo JEPW, Bishop DJ, Sale C, Gualano B. Comparative physiology investigations support a role for histidine-containing dipeptides in intracellular acid-base regulation of skeletal muscle. Comp Biochem Physiol A Mol Integr Physiol. 2019 Aug;234:77-86. doi: 10.1016/j.cbpa.2019.04.017. Epub 2019 Apr 25.
PubMed 31029715Boldyrev AA, Aldini G, Derave W. Physiology and pathophysiology of carnosine. Physiol Rev. 2013 Oct;93(4):1803-45. doi: 10.1152/physrev.00039.2012.
PubMed 24137022Ciulla MM, Paliotti R, Carini M, Magrini F, Aldini G. Fibrosis, Enzymatic and Non-Enzymatic Cross-Links in Hypertensive Heart Disease. Cardiovasc Hematol Disord Drug Targets. 2011;11(2):61-73. doi: 10.2174/187152911798347025.
PubMed 22044034Menon K, Mousa A, de Courten B. Effects of supplementation with carnosine and other histidine-containing dipeptides on chronic disease risk factors and outcomes: protocol for a systematic review of randomised controlled trials. BMJ Open. 2018 Mar 22;8(3):e020623. doi: 10.1136/bmjopen-2017-020623.
PubMed 29567852Zhang Y, Wang X, Li H, Ni C, Du Z, Yan F. Human oral microbiota and its modulation for oral health. Biomed Pharmacother. 2018 Mar;99:883-893. doi: 10.1016/j.biopha.2018.01.146. Epub 2018 Feb 20.
PubMed 29710488Holtfreter B, Albandar JM, Dietrich T, Dye BA, Eaton KA, Eke PI, Papapanou PN, Kocher T; Joint EU/USA Periodontal Epidemiology Working Group. Standards for reporting chronic periodontitis prevalence and severity in epidemiologic studies: Proposed standards from the Joint EU/USA Periodontal Epidemiology Working Group. J Clin Periodontol. 2015 May;42(5):407-12. doi: 10.1111/jcpe.12392. Epub 2015 May 7.
PubMed 25808877
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHoral: Effects of Carnosine Supplementation on Quantity/Quality of Oral Salivae in Healthy Volunteer and in Subjects Affected by Common Oral Pathologies.
- ClinicalTrials.gov ID
- NCT04295525
- Acronym / sponsor ID
- PHoral / P0A.20.20
- Conditions
- Oral Diseases
- Keywords
- dental erosions, caries, périodontopathies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 4 Mar 2020 (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.
The aim of this study is to elucidate the mutual relationship between salivae characteristics and oral microbiome and to compare them with common oral disease; furthermore, by using specific bioinformatic tools to analyse the data, the potentials of Carnosine in preventing/treating oral diseases and its mechanism of action will be addressed by using quantitative proteomics.
Detailed description
The pH of the oral cavity is a synthetic parameter that underlies a multifactorial process of continuous adjustment that includes the effect of salivae as a buffer and the contribution of the oral cavity microbiome. In some diseases of the oral cavity an alteration of these adjustment mechanisms is supposed to alter the normal flow of salivae and, consequently, the pH and the oral microbiome with the expansion of potentially pathogenic strains such as e.g. streptococcus viridans.
Carnosine (Car) is an endogenous dipeptide, composed of β-alanine and L-histidine, that was originally discovered in larger amounts in skeletal muscle of some vertebrates, including humans, showing a greater dependence on non-oxidative forms of energy metabolism. This peculiar association with muscular tissue and its pH-buffering properties has led to associate Car with the intracellular acid-base homeostasis of muscles. More recently, the physiological role of Car has been expanded beyond the intracellular buffering properties, supporting a role in sarcoplasmic Ca2+ regulation and neutralisation of reactive oxygen species (ROS). It is well known that ROS induce the formation of reactive electrophilic carbonyl species by reacting with lipids and sugars which, in turn, react with proteins forming irreversible adducts (AGEs, ALEs and EAGLEs) and cross-links that may affect the cardiovascular wall matrix that becomes less distensible, especially during the ageing process and/or diseases. Thus it is thought that Car and, indeed, other histidine-containing peptide (HCD), may prevent chronic diseases via their anti-inflammatory, anti-oxidative, anti-glycating, anti-ischaemic and chelating properties. Furthermore, the localisation of Car in other tissues such as brain, olfactory bulb, heart, stomach, pancreas, kidney has suggested further potential uses in preventing e.g. neurodegenerative disorder and cognitive function or the development of type II diabetes.
The oral microbiome (OM) is a relevant part of the whole human MO since it contains several different niches, with distinct microbial communities, colonising the oral cavity (OC), including not only bacteria but also fungi, viruses, archaea and protozoa. These communities form a complex ecological system that influences OC and systemic health. Indeed the prevalent oral diseases (OD), namely dental caries and periodontal diseases, are believed to be microbiota-related. Furthermore, several evidences support the theory that many systemic diseases are associated with an altered OM, among these the most frequently associated diseases are metabolic, such as diabetes, cardiovascular and oncological ones. For their prevalence worldwide, among OD, periodontal infection, including gingivitis and chronic periodontitis, is possibly the most prevalent human microbial diseases (HMD).
In order to protect the OC from HMD, in the present project Car has been chosen as a possible preventive and/or therapeutic principle for its aforementioned multiple biological effects. Thus the safety and efficacy of AqualiefTM (Metis Healthcare s.r.l., Milano, Italy) a 400 mg mucoadhesive oral tablet (13 x 4 mm), that recognise Car as main ingredient, will be tested on healthy volunteer and in subjects affected by common OD.
The main objectives of this protocol are to estimate the quantity/quality of oral salivae and OM in healthy volunteer and in patients affected by common OD, before and after 7 days of treatment with AqualiefTM, 1 tablet twice. The characteristics of oral salivae (Sal) that will be studied are:
a - unstimulated and stimulated (paraffin-activated) salivary flow rates, pH and buffering power; b - quantitative proteomics (QP), on selected targets, representing the main metabolites/components of OM.
By matching Sal characteristics with OM and comparing them with OD, it is expected to elucidate their mutual relationship; furthermore, by using specific bioinformatic tools to analyse the data, the potentials of Car in preventing/treating OD and its mechanism of action will be addressed by using QP.
The study will take place at the Odontoiatric University Clinic (OUC), Istituto Stomatologico Italiano (ISI) of Milan, Italy, in a prospective, randomised, double-blind, placebo-controlled fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls subjects placebo | Placebo comparator | Dietary Supplement: placebo mucoadhesive oral tabletPlacebo mucoadhesive oral tablet |
| Controls subjects active Treatment | Experimental | Dietary Supplement: 400 mg mucoadhesive oral tabletAqualiefTM 400 mg mucoadhesive oral tablet |
| Diseased subjects placebo | Placebo comparator | Dietary Supplement: placebo mucoadhesive oral tabletPlacebo mucoadhesive oral tablet |
| Diseased subjects active Treatment | Experimental | Dietary Supplement: 400 mg mucoadhesive oral tabletAqualiefTM 400 mg mucoadhesive oral tablet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- dental erosions (De)
- caries (Ca)
- périodontopathies (Pe)
Key exclusion criteria (6 listed)
- allergies/intolerances to the consumption of Carnosine
- taking other food supplements
- any type of drug treatment (interview)
- smoking
- pregnancy/lactation
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 |
|---|---|---|
| 400 mg mucoadhesive oral tabletAqualiefTM (Metis Healthcare s.r.l., Milano, Italy) | Dietary supplement | Controls subjects active Treatment, Diseased subjects active Treatment |
| placebo mucoadhesive oral tabletplacebo | Dietary supplement | Controls subjects placebo, Diseased subjects placebo |
Primary outcome
Effects on oral pH.
Time frame: 7 days
Any change of oral pH from basal.
Saliva Production unstimulated.
Time frame: 7 days
Change of oral saliva production, unstimulated.
Saliva Production stimulated.
Time frame: 7 days
Change of oral saliva production, stimulated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Results publication: PubMed 18335122de Almeida Pdel V, Gregio AM, Machado MA, de Lima AA, Azevedo LR. Saliva composition and functions: a comprehensive review. J Contemp Dent Pract. 2008 Mar 1;9(3):72-80.
- Results publication: PubMed 26662484Marsh PD, Do T, Beighton D, Devine DA. Influence of saliva on the oral microbiota. Periodontol 2000. 2016 Feb;70(1):80-92. doi: 10.1111/prd.12098.
- Results publication: PubMed 27102203Grassl N, Kulak NA, Pichler G, Geyer PE, Jung J, Schubert S, Sinitcyn P, Cox J, Mann M. Ultra-deep and quantitative saliva proteome reveals dynamics of the oral microbiome. Genome Med. 2016 Apr 21;8(1):44. doi: 10.1186/s13073-016-0293-0.
- Results publication: PubMed 30338752Abranches J, Zeng L, Kajfasz JK, Palmer SR, Chakraborty B, Wen ZT, Richards VP, Brady LJ, Lemos JA. Biology of Oral Streptococci. Microbiol Spectr. 2018 Oct;6(5):10.1128/microbiolspec.gpp3-0042-2018. doi: 10.1128/microbiolspec.GPP3-0042-2018.
- Results publication: PubMed 31029715Dolan E, Saunders B, Harris RC, Bicudo JEPW, Bishop DJ, Sale C, Gualano B. Comparative physiology investigations support a role for histidine-containing dipeptides in intracellular acid-base regulation of skeletal muscle. Comp Biochem Physiol A Mol Integr Physiol. 2019 Aug;234:77-86. doi: 10.1016/j.cbpa.2019.04.017. Epub 2019 Apr 25.
- Results publication: PubMed 24137022Boldyrev AA, Aldini G, Derave W. Physiology and pathophysiology of carnosine. Physiol Rev. 2013 Oct;93(4):1803-45. doi: 10.1152/physrev.00039.2012.
- Results publication: PubMed 22044034Ciulla MM, Paliotti R, Carini M, Magrini F, Aldini G. Fibrosis, Enzymatic and Non-Enzymatic Cross-Links in Hypertensive Heart Disease. Cardiovasc Hematol Disord Drug Targets. 2011;11(2):61-73. doi: 10.2174/187152911798347025.
- Results publication: PubMed 29567852Menon K, Mousa A, de Courten B. Effects of supplementation with carnosine and other histidine-containing dipeptides on chronic disease risk factors and outcomes: protocol for a systematic review of randomised controlled trials. BMJ Open. 2018 Mar 22;8(3):e020623. doi: 10.1136/bmjopen-2017-020623.
- Results publication: PubMed 29710488Zhang Y, Wang X, Li H, Ni C, Du Z, Yan F. Human oral microbiota and its modulation for oral health. Biomed Pharmacother. 2018 Mar;99:883-893. doi: 10.1016/j.biopha.2018.01.146. Epub 2018 Feb 20.
- Results publication: PubMed 25808877Holtfreter B, Albandar JM, Dietrich T, Dye BA, Eaton KA, Eke PI, Papapanou PN, Kocher T; Joint EU/USA Periodontal Epidemiology Working Group. Standards for reporting chronic periodontitis prevalence and severity in epidemiologic studies: Proposed standards from the Joint EU/USA Periodontal Epidemiology Working Group. J Clin Periodontol. 2015 May;42(5):407-12. doi: 10.1111/jcpe.12392. Epub 2015 May 7.
- 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.
Michele Ciulla, MD principal investigator
Lab. Clin. Informatics & Cardiovascular Imaging, University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400 mg mucoadhesive oral tablet in people with Oral Diseases, run by University of Milan at 1 site in Italy.
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 6 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: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dino Re, MD (+39-0254176231, dino.re@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on oral pH. (time frame: 7 days). The study lists 3 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 NCT04295525, 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 18 May 2022.