Situational AnxietyNCT06463145
Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People
A study testing Vanizem in people with Situational Anxiety, run by Nektium Pharma SL at 1 site in Spain.
Trial summary
The goal of this pilot clinical trial is to evaluate if one specific botanical extract from Grains of Paradise works to induce anxiolytic effect in adult people in stress or anxiety situations It will also learn about the extract's positive effects on sleep and mood. Read more about this study
- Who is it for?
- Ages 40 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Situational Anxiety
- What is being tested?
- Vanizem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 20 May 2023
- 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 40 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 40 and 50 year of age;
- Healthy people with moderate anxiety: HAM-A score in a range between 18 and 24;
- Subject able and willing to participate to the study by complying with the protocol procedures as confirmed by his dated and signed informed consent form;
Who cannot join
- Score greater than 20 points on the Hamilton Depression Rating Scale (HDRS);
- Receiving medical treatment for anxiety, stress or depression;
- Drugs and alcohol dependence;
- Serious personality disorders that may interfere with participation in the study (psychosis, intense suicidal ideation, etc.);
- In the case of women, having the intention of becoming pregnant;
- Epileptic disorders;
Show all 9Show fewer
- Liver disorders (cirrhosis, hepatitis, etc.);
- Professional athletes or those who frequently engage in extreme physical activities;
- Impossibility of completing the intervention period due to external factors;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Plant Extract Modulating the Endocannabinoid System and Its Anxiolytic Capacity on Elderly People in Situations of Stress or Anxiety
The goal of this pilot clinical trial is to evaluate if one specific botanical extract from Grains of Paradise works to induce anxiolytic effect in adult people in stress or anxiety situations It will also learn about the extract's positive effects on sleep and mood. The main questions it aims to answer are:
Does botanical extract exert an anxiolytic effect on the participants under stress or anxiety circumstances? Does botanical extract promote positive effects on Mood and nocturnal sleep? Does botanical extract influence body parameters like Blood pressure, inflammatory indicators or stress hormones? Researchers will compare tree doses of botanical extract (50,100 or 150mg) to a placebo (a look-alike substance that contains no herbal product) to see if herbal extract support anxiolytic effect.
Read more
Participants will:
Take herbal extract or a placebo daily for 3 days. Visit the clinic two times: at the start of the study (day0) and to the end of the study (Day +2)for checkups and tests.
Keep a diary with questions about their activities, daily foods and physicals perceptions.
Read the detailed description
The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the effects of standardized aframomum melegueta seed extract (AME) supplementation on anxiety, mood and sleep quality in healthy men and women experiencing anxious situations. A total of 37 participants were randomly assigned to either AME-first groups or placebo-first group; participants were taken 50, 100 or 150 mg of either AME or matched placebo peels daily for three days. This period is followed by a 1 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention. All Participants were instructed to follow a standardized training program throughout the study, including washout periods to maintain uniformity in physical activity and reduce the effect that exercise can have on stress management. The effects of supplement AME doses compared with a placebo, were evaluated using measures to assess anxiety [The Hamilton Anxiety Scale (HAM-A)], mood [Adapted Profile Mood State (POMS)], sleep quality [Sleep Evaluation Questionnaire (LSEQ) and Pittsburgh Sleep Quality Index (PSQI)]. In addition, some physiological (Blood pressure and heart rate variability), biochemical (minerals, hepatic enzymes and inflammatory biomarkers) and hematological variables (Complete cell count) were determined. Testing was completed at the beginning (Day0) and at the end (Day2) of the supplementation periods with the extract and placebo products to assess acute effects following 3 days of daily use.
- Conditions
- Situational Anxiety
- Being tested
- Vanizem, Placebo
- Keywords
- Anxiety, Aframomum melegueta seed, Herbal extract, FAAH inhibitor, Quality sleep, Grains of paradise
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VanizemDietary supplement
Aframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol
PlaceboDietary supplement
Food grade Maltodextrin 12
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Pill of Food grade Maltodextrin 12 . Once daily for three days. Receives: Dietary Supplement: Placebo |
| Vanizem 50mg | Experimental | Pill of Aframomum melegueta extract 50 mg with Food grade Maltodextrin 12 . Once daily for three days. Receives: Dietary Supplement: Vanizem |
| Vanizem 100mg | Experimental | Pill of Aframomum melegueta extract 100 mg with Food grade Maltodextrin 12 . Once daily for three days. Receives: Dietary Supplement: Vanizem |
| Vanizem 150mg | Experimental | Pill of Aframomum melegueta extract 150 mg with Food grade Maltodextrin 12 . Once daily for three days. Receives: Dietary Supplement: Vanizem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Anxiety Rating Scale (HAM-A) score
Change in HAM-A score for Vanizem group compared to placebo control group. 14-items questionnaire reflecting 13 categories of anxiety-related symptom to measure anxiety.
Measured: At baseline (day 0) and after intake period (day 2+)
Secondary outcomes (12)
Change in Profile of Mood States (POMS) score
Change in POMS score for Vanizem group compared to placebo control group. 65-items to evaluate short-term emotional states and represent six subscales assessing tension-anxiety, depression, anger-hostility, fatigue, confusion-bewilderment, and vigor-activity.
Measured: At baseline (day 0) and after intake period (day 2+)
Change in Pittsburgh Sleep Quality Index (PSQI) score
Change in PSQI score for Vanizem group compared to placebo control group. 24-items measuring seven dimensions that can be broadly categorized into sleep efficiency factors (sleep quality, sleep latency, sleep duration, and habitual sleep efficiency) and sleep disturbance factors (sleep disturbance, use of sleep medications, and daytime disturbance).
Measured: At baseline (day 0) and after intake period (day 2+)
Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score. 10-items evaluating four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness.
Change in LSEQ score for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 1+ and day 2+)
Change in Heart Rate Variability (HRV)
Change HRV score for Vanizem group compared to placebo control group. Heart rate variability measured as interbeat intervals (ms) has been collected with POLAR H10+ heart rate bands during sleeping hours.
Measured: At baseline (day 0) and after intake period (day 1+ and day 2+)
Change in blood pressure score
Change in systolic and diastolic blood pressure (mmHg) for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Change in blood cells count
Changes in a neutrophils, lymphocyte, monocyte, eosinophil, basophil, platelet and red blood cell counts (Cells/mcL) for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Change in blood minerals levels
Changes in Magnesium (mmol/L) and Zinc (mcmol/L) levels for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Change in blood electrolyte levels
Changes in Sodium and Chloride levels (mEq/L) for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Change in serum hepatic enzymes
Changes in gamma-glutamyltransferase (GGT), serum glutamic pyruvic transaminase (GPT), serum glutamic oxaloacetic transaminase (GOT) and alkaline phosphatase (AP) levels (IU/L) for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Change proinflammatory serum biomarkers
Changes in interleukin-1, interleukin-6, interleukin-8 and tumour necrosis factor alpha levels (pg/mL) for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Change in protein serum biomarker of inflammation
Changes in c-reactive protein levels (mg/L) for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Change in serum biomarker of stress
Changes in cortisol (mcg/dL) levels for Vanizem group compared to placebo control group.
Measured: At baseline (day 0) and after intake period (day 2+)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Mar 2023
- Primary completion12 Apr 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Situational AnxietyStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektium Pharma SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kinetic Performance S.L.
- Responsible party
- Sponsor
- Investigators
- Laura López-Rios, PhD, Principal investigator, Nektium Pharma SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463145
- Sponsor's protocol ID
- AME_HCT_2023
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Umukoro S. and Aladeokin A. C., Therapeutic effects of grains of paradise (aframomum melegueta) seeds Nuts and Seeds in Health and Disease Prevention, 2011, Academic Press, Cambridge, MA, USA, 535-543.
Ilic NM, Dey M, Poulev AA, Logendra S, Kuhn PE, Raskin I. Anti-inflammatory activity of grains of paradise (Aframomum melegueta Schum) extract. J Agric Food Chem. 2014 Oct 29;62(43):10452-7. doi: 10.1021/jf5026086. Epub 2014 Oct 20.
PubMed 25293633Ogwu, M.C., Dunkwu-Okafor, A., Omakor, I.A., Izah, S.C. (2024). Medicinal Spice, Aframomum melegueta: An Overview of the Phytochemical Constituents, Nutritional Characteristics, and Ethnomedicinal Values for Sustainability. In: Izah, S.C., Ogwu, M.C., Akram, M. (eds) Herbal Medicine Phytochemistry. Reference Series in Phytochemistry. Springer, Cham. https://doi.org/10.1007/978-3-031-21973-3_72-1
Umukoro S, Ashorobi RB. Further studies on the antinociceptive action of aqueous seed extract of Aframomum melegueta. J Ethnopharmacol. 2007 Feb 12;109(3):501-4. doi: 10.1016/j.jep.2006.08.025. Epub 2006 Sep 3.
PubMed 17023130Ford JL, Ildefonso K, Jones ML, Arvinen-Barrow M. Sport-related anxiety: current insights. Open Access J Sports Med. 2017 Oct 27;8:205-212. doi: 10.2147/OAJSM.S125845. eCollection 2017.
PubMed 29138604Halson SL, Juliff LE. Sleep, sport, and the brain. Prog Brain Res. 2017;234:13-31. doi: 10.1016/bs.pbr.2017.06.006. Epub 2017 Jul 17.
PubMed 29031461Patel S, Hill MN, Cheer JF, Wotjak CT, Holmes A. The endocannabinoid system as a target for novel anxiolytic drugs. Neurosci Biobehav Rev. 2017 May;76(Pt A):56-66. doi: 10.1016/j.neubiorev.2016.12.033.
PubMed 28434588Batista LA, Gobira PH, Viana TG, Aguiar DC, Moreira FA. Inhibition of endocannabinoid neuronal uptake and hydrolysis as strategies for developing anxiolytic drugs. Behav Pharmacol. 2014 Sep;25(5-6):425-33. doi: 10.1097/FBP.0000000000000073.
PubMed 25083569
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Plant Extract Modulating the Endocannabinoid System and Its Anxiolytic Capacity on Elderly People in Situations of Stress or Anxiety
- ClinicalTrials.gov ID
- NCT06463145
- Acronym / sponsor ID
- AME_HCT_2023
- Conditions
- Situational Anxiety
- Keywords
- Anxiety, Aframomum melegueta seed, Herbal extract, FAAH inhibitor, Quality sleep, Grains of paradise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Nektium Pharma SLIndustry (pharma, biotech, devices)
- Collaborators
- Kinetic Performance S.L.
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 17 Jun 2024 (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 goal of this pilot clinical trial is to evaluate if one specific botanical extract from Grains of Paradise works to induce anxiolytic effect in adult people in stress or anxiety situations It will also learn about the extract's positive effects on sleep and mood. The main questions it aims to answer are:
Does botanical extract exert an anxiolytic effect on the participants under stress or anxiety circumstances? Does botanical extract promote positive effects on Mood and nocturnal sleep? Does botanical extract influence body parameters like Blood pressure, inflammatory indicators or stress hormones? Researchers will compare tree doses of botanical extract (50,100 or 150mg) to a placebo (a look-alike substance that contains no herbal product) to see if herbal extract support anxiolytic effect.
Participants will:
Take herbal extract or a placebo daily for 3 days. Visit the clinic two times: at the start of the study (day0) and to the end of the study (Day +2)for checkups and tests.
Keep a diary with questions about their activities, daily foods and physicals perceptions.
Detailed description
The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the effects of standardized aframomum melegueta seed extract (AME) supplementation on anxiety, mood and sleep quality in healthy men and women experiencing anxious situations. A total of 37 participants were randomly assigned to either AME-first groups or placebo-first group; participants were taken 50, 100 or 150 mg of either AME or matched placebo peels daily for three days. This period is followed by a 1 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention. All Participants were instructed to follow a standardized training program throughout the study, including washout periods to maintain uniformity in physical activity and reduce the effect that exercise can have on stress management. The effects of supplement AME doses compared with a placebo, were evaluated using measures to assess anxiety [The Hamilton Anxiety Scale (HAM-A)], mood [Adapted Profile Mood State (POMS)], sleep quality [Sleep Evaluation Questionnaire (LSEQ) and Pittsburgh Sleep Quality Index (PSQI)]. In addition, some physiological (Blood pressure and heart rate variability), biochemical (minerals, hepatic enzymes and inflammatory biomarkers) and hematological variables (Complete cell count) were determined. Testing was completed at the beginning (Day0) and at the end (Day2) of the supplementation periods with the extract and placebo products to assess acute effects following 3 days of daily use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPill of Food grade Maltodextrin 12 . Once daily for three days. |
| Vanizem 50mg | Experimental | Dietary Supplement: VanizemPill of Aframomum melegueta extract 50 mg with Food grade Maltodextrin 12 . Once daily for three days. |
| Vanizem 100mg | Experimental | Dietary Supplement: VanizemPill of Aframomum melegueta extract 100 mg with Food grade Maltodextrin 12 . Once daily for three days. |
| Vanizem 150mg | Experimental | Dietary Supplement: VanizemPill of Aframomum melegueta extract 150 mg with Food grade Maltodextrin 12 . Once daily for three days. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female between 40 and 50 year of age;
- Healthy people with moderate anxiety: HAM-A score in a range between 18 and 24;
- Subject able and willing to participate to the study by complying with the protocol procedures as confirmed by his dated and signed informed consent form;
Key exclusion criteria (9 listed)
- Score greater than 20 points on the Hamilton Depression Rating Scale (HDRS);
- Receiving medical treatment for anxiety, stress or depression;
- Drugs and alcohol dependence;
- Serious personality disorders that may interfere with participation in the study (psychosis, intense suicidal ideation, etc.);
- In the case of women, having the intention of becoming pregnant;
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 |
|---|---|---|
| VanizemAframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol | Dietary supplement | Vanizem 100mg, Vanizem 150mg, Vanizem 50mg |
| PlaceboFood grade Maltodextrin 12 | Dietary supplement | Placebo |
Primary outcome
Change in Hamilton Anxiety Rating Scale (HAM-A) score
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in HAM-A score for Vanizem group compared to placebo control group. 14-items questionnaire reflecting 13 categories of anxiety-related symptom to measure anxiety.
12 secondary outcomes
Change in Profile of Mood States (POMS) score
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in Pittsburgh Sleep Quality Index (PSQI) score
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score. 10-items evaluating four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness.
Time frame: At baseline (day 0) and after intake period (day 1+ and day 2+)
Change in Heart Rate Variability (HRV)
Time frame: At baseline (day 0) and after intake period (day 1+ and day 2+)
Change in blood pressure score
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in blood cells count
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in blood minerals levels
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in blood electrolyte levels
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in serum hepatic enzymes
Time frame: At baseline (day 0) and after intake period (day 2+)
Change proinflammatory serum biomarkers
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in protein serum biomarker of inflammation
Time frame: At baseline (day 0) and after intake period (day 2+)
Change in serum biomarker of stress
Time frame: At baseline (day 0) and after intake period (day 2+)
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 Jul 2024.
- BackgroundUmukoro S. and Aladeokin A. C., Therapeutic effects of grains of paradise (aframomum melegueta) seeds Nuts and Seeds in Health and Disease Prevention, 2011, Academic Press, Cambridge, MA, USA, 535-543.
- Background: PubMed 25293633Ilic NM, Dey M, Poulev AA, Logendra S, Kuhn PE, Raskin I. Anti-inflammatory activity of grains of paradise (Aframomum melegueta Schum) extract. J Agric Food Chem. 2014 Oct 29;62(43):10452-7. doi: 10.1021/jf5026086. Epub 2014 Oct 20.
- BackgroundOgwu, M.C., Dunkwu-Okafor, A., Omakor, I.A., Izah, S.C. (2024). Medicinal Spice, Aframomum melegueta: An Overview of the Phytochemical Constituents, Nutritional Characteristics, and Ethnomedicinal Values for Sustainability. In: Izah, S.C., Ogwu, M.C., Akram, M. (eds) Herbal Medicine Phytochemistry. Reference Series in Phytochemistry. Springer, Cham. https://doi.org/10.1007/978-3-031-21973-3_72-1
- Background: PubMed 17023130Umukoro S, Ashorobi RB. Further studies on the antinociceptive action of aqueous seed extract of Aframomum melegueta. J Ethnopharmacol. 2007 Feb 12;109(3):501-4. doi: 10.1016/j.jep.2006.08.025. Epub 2006 Sep 3.
- Background: PubMed 29138604Ford JL, Ildefonso K, Jones ML, Arvinen-Barrow M. Sport-related anxiety: current insights. Open Access J Sports Med. 2017 Oct 27;8:205-212. doi: 10.2147/OAJSM.S125845. eCollection 2017.
- Background: PubMed 29031461Halson SL, Juliff LE. Sleep, sport, and the brain. Prog Brain Res. 2017;234:13-31. doi: 10.1016/bs.pbr.2017.06.006. Epub 2017 Jul 17.
- Background: PubMed 28434588Patel S, Hill MN, Cheer JF, Wotjak CT, Holmes A. The endocannabinoid system as a target for novel anxiolytic drugs. Neurosci Biobehav Rev. 2017 May;76(Pt A):56-66. doi: 10.1016/j.neubiorev.2016.12.033.
- Background: PubMed 25083569Batista LA, Gobira PH, Viana TG, Aguiar DC, Moreira FA. Inhibition of endocannabinoid neuronal uptake and hydrolysis as strategies for developing anxiolytic drugs. Behav Pharmacol. 2014 Sep;25(5-6):425-33. doi: 10.1097/FBP.0000000000000073.
- 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.
Laura López-Rios, PhD principal investigator
Nektium Pharma SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanizem in people with Situational Anxiety, run by Nektium Pharma SL at 1 site in Spain.
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 1 Jul 2024. 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 Spain. 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 in Hamilton Anxiety Rating Scale (HAM-A) score (time frame: At baseline (day 0) and after intake period (day 2+)). 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 NCT06463145, which also lists 8 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 Jul 2024.