Gene ExpressionNCT07855198
The Improving Effects of French Maritime Pine Bark Extract on Antioxidation and Anti-inflammation a in Post-menopausal Women Based on Nutrigenomic Approach
A study testing French maritime pine bark extract in people with Gene Expression and Nutrigenomics, run by Taipei Medical University.
Trial summary
The goal of this clinical trial is to investigate whether French maritime pine bark extract (FMPBE) supplementation can improve antioxidant capacity and reduce inflammation in postmenopausal women aged 40-75 years. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gene Expression, Nutrigenomics
- What is being tested?
- French maritime pine bark extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 40-75 years.
- Free from chronic diseases and not taking regular medications.
Who cannot join
- Individuals with chronic diseases.
- Individuals with known allergies to the study materials.
- Individuals currently taking nutritional supplements that may interfere with the study outcomes.
About this study
The goal of this clinical trial is to investigate whether French maritime pine bark extract (FMPBE) supplementation can improve antioxidant capacity and reduce inflammation in postmenopausal women aged 40-75 years.
The main questions it aims to answer are:
Does FMPBE supplementation improve antioxidant status and reduce oxidative stress? Does FMPBE supplementation reduce inflammatory responses and affect related gene expression? Researchers will compare an FMPBE treatment group with a placebo group. Participants will take one capsule daily for 30 days and undergo blood collection on Day 0 and Day 30 for biochemical and gene expression analyses. Participants will also complete assessments of anthropometric measurements, blood pressure, dietary intake, and quality of life.
- Conditions
- Gene Expression, Nutrigenomics
- Being tested
- French maritime pine bark extract, Placebo
- Keywords
- pine bark extract, Postmenopausal women, antioxidant, Anti-inflammatory, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
French maritime pine bark extractDietary supplement
participants who meet the inclusion criteria will be randomly divided into Placebo (P) and treatment (T) groups. Participants in the P group will be provided with one capsule of placebo without FMPBE whereas participants in the T group will be provided with one capsule of placebo with FMPBE (100mg) per day for 30 days. Blood samples will be collected on Day 0 and Day 30 for biochemical and genetic analyses, accompanied by the administration of a quality-of-life (QoL) questionnaire to assess participants' overall well-being. At the same time, they will accept the measurement of anthropometric measurements and blood pressure, also be interviewed with 24 hours dietary recall questionnaire.
PlaceboOther
participants who meet the inclusion criteria will be randomly divided into Placebo (P) and treatment (T) groups. Participants in the P group will be provided with one capsule of placebo without FMPBE whereas participants in the T group will be provided with one capsule of placebo with FMPBE (100mg) per day for 30 days. Blood samples will be collected on Day 0 and Day 30 for biochemical and genetic analyses, accompanied by the administration of a quality-of-life (QoL) questionnaire to assess participants' overall well-being. At the same time, they will accept the measurement of anthropometric measurements and blood pressure, also be interviewed with 24 hours dietary recall questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| French maritime pine bark extract | Experimental | Dietary supplement: French maritime pine bark extract(contains sesamin 100 mg per capsule) This group will be given supplements for 30 days. Receives: Dietary Supplement: French maritime pine bark extract |
| Placebo Comparator: placebo | Placebo comparator | Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline quality-of-life (QoL) in 30 days
Quality of life will be assessed using the Menopause-specific Quality of Life (MENQOL) questionnaire, consisting of 53 items. Each item is scored on a 6-point scale from 1 to 6, with higher scores indicating better quality of life. The total score ranges from 53 to 318, with higher total scores indicating better quality of life. The questionnaire assesses menopause-related symptoms and disturbances experienced during the preceding 1-month period.
Measured: At the start of the experiment and at the Day 30
Antioxidative status
Change from baseline in plasma thiobarbituric acid-reactive substances (TBARS) concentration at Day 30.Plasma TBARS concentration will be measured as an indicator of lipid peroxidation and oxidative stress. The concentration will be reported in nmol/ml.
Measured: At baseline and Day 30
Antioxidative status
Change from baseline in erythrocytic reduced glutathione-to-oxidized glutathione ratio (GSH/GSSG ratio) at Day 30.The ratio of reduced glutathione (GSH) to oxidized glutathione (GSSG) in erythrocytes will be calculated as an indicator of cellular redox status. The ratio will be reported as a unitless value.
Measured: At the start of the experiment and at the Day 30
Antioxidative status
Change from baseline in erythrocytic reduced glutathione (GSH) concentration at Day 30.Erythrocytic reduced glutathione (GSH) concentration will be measured and reported in μmol/g Hb.
Measured: At baseline and Day 30
Antioxidative status
Change from baseline in plasma reduced glutathione (GSH) concentration at Day 30.Plasma reduced glutathione (GSH) concentration will be measured and reported in µmol/L.
Measured: At baseline and Day 30
Inflammatory status
Change from baseline in plasma tumor necrosis factor-alpha (TNF-α) concentration at Day 30.Plasma TNF-α concentration will be measured and reported in pg/mL.
Measured: At the start of the experiment and at the Day 30
Inflammatory status
Change from baseline in plasma interleukin-1 beta (IL-1β) concentration at Day 30.Plasma IL-1β concentration will be measured and reported in pg/mL.
Measured: At the start of the experiment and at the Day 30
Inflammatory status
Change from baseline in plasma interleukin-6 (IL-6) concentration at Day 30.Plasma IL-6 concentration will be measured and reported in pg/mL.
Measured: At the start of the experiment and at the Day 30
Inflammatory status
Change from baseline in plasma high-sensitivity C-reactive protein (hsCRP) concentration at Day 30.Plasma hsCRP concentration will be measured and reported in mg/dL.
Measured: At the start of the experiment and at the Day 30
Anti-inflammatory status
Change from baseline in plasma interleukin-10 (IL-10) concentration at Day 30.Plasma IL-10 concentration will be measured and reported in pg/mL.
Measured: At the start of the experiment and at the Day 30
Anti-inflammatory status
Change from baseline in plasma transforming growth factor-beta (TGF-β) concentration at Day 30.Plasma TGF-β concentration will be measured and reported in pg/mL.
Measured: At the start of the experiment and at the Day 30
Secondary outcomes (21)
Antioxidative enzyme activities
Change from baseline in erythrocytic superoxide dismutase (SOD) activity at Day 30.Erythrocytic SOD activity will be measured and reported in U/mg Hb.
Measured: At the start of the experiment and at the Day 30
Antioxidant-related gene expression
Relative gene expression levels of antioxidant-related genes, including SOD1, SOD2, SOD3, CAT, GPX1, GPX3, GR, and HMOX1, measured in whole blood by reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.
Measured: At the start of the experiment and at the Day 30
Inflammation-related gene expression
Relative gene expression levels of inflammation-related genes, including tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6), will be measured in whole blood using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.
Measured: At the start of the experiment and at the Day 30
Lipid profile
Change from baseline in lipid profile at Day 30.Serum high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol (TC) will be assessed and reported in mg/dL.
Measured: At the start of the experiment and at the Day 30
Anthropometric measurements
Change from baseline in body weight at Day 30.Body weight will be measured in kilograms (kg).
Measured: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Change from baseline in plasma superoxide dismutase (SOD) activity at Day 30.Plasma SOD activity will be measured and reported in U/mL.
Measured: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Change from baseline in erythrocytic catalase (CAT) activity at Day 30.Erythrocytic CAT activity will be measured and reported in U/mg Hb.
Measured: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Change from baseline in plasma catalase (CAT) activity at Day 30.Plasma CAT activity will be measured and reported in U/mL.
Measured: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Change from baseline in erythrocytic glutathione reductase (GR) activity at Day 30.Erythrocytic GR activity will be measured and reported in U/g Hb.
Measured: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Change from baseline in plasma glutathione reductase (GR) activity at Day 30.Plasma GR activity will be measured and reported in U/L.
Measured: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Change from baseline in erythrocytic glutathione peroxidase (GPX) activity at Day 30.Erythrocytic GPX activity will be measured and reported in U/g Hb.
Measured: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Change from baseline in plasma glutathione peroxidase (GPX) activity at Day 30.Plasma GPX activity will be measured and reported in U/L.
Measured: At the start of the experiment and at the Day 30
anti-inflammation-related gene expression
Relative gene expression levels of anti-inflammatory-related genes, including interleukin-10 (IL-10) and transforming growth factor-beta (TGF-β), will be measured in whole blood using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.
Measured: At the start of the experiment and at the Day 30
Regulatory and Redox-related Gene Expression
Relative gene expression levels of interferon regulatory factor 2 (IRF2), nuclear factor kappa B (NF-κB), nuclear factor erythroid 2-related factor 2 (NRF2), and Kelch-like ECH-associated protein 1 (KEAP1) will be measured in whole blood using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.
Measured: At the start of the experiment and at the Day 30
Liver function
Change from baseline in liver function parameters at Day 30. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels will be assessed and reported in U/L.
Measured: At the start of the experiment and at the Day 30
Kidney function
Change from baseline in kidney function parameters at Day 30.Serum blood urea nitrogen (BUN), creatinine, and uric acid levels, as well as estimated glomerular filtration rate (eGFR), will be assessed. BUN, creatinine, and uric acid will be reported in mg/dL, and eGFR will be reported in mL/min.
Measured: At the start of the experiment and at the Day 30
Hematology
WBC (10^3/uL), RBC (10^6/uL), hemoglobin (g/dL), hematocrit (%), MCV(fL), MCH (pg), MCHC (g/dL), platelet (10^3/uL), neutrophils (%), lymphocytes (%), monocytes (%), eosinophils (%) and basophils(%)
Measured: At the start of the experiment and at the Day 30
Anthropometric measurements
Change from baseline in height and waist circumference at Day 30.Height and waist circumference will be measured and reported in centimeters (cm)
Measured: At the start of the experiment and at the Day 30
Anthropometric measurements
Change from baseline in body composition at Day 30.Body composition will be assessed by body fat percentage and skeletal muscle percentage, both reported as percentages (%).
Measured: At the start of the experiment and at the Day 30
Anthropometric measurements
Change from baseline in body mass index (BMI) at Day 30 Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m².
Measured: At the start of the experiment and at the Day 30
Anthropometric measurements
Change from baseline in blood pressure at Day 30 Blood pressure will be assessed by measuring systolic blood pressure and diastolic blood pressure, both reported in millimeters of mercury (mmHg).
Measured: At the start of the experiment and at the Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start7 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene ExpressionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- QWB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855198
- Sponsor's protocol ID
- N202605084
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improving Effects of French Maritime Pine Bark Extract on Antioxidation and Anti-inflammation a in Post-menopausal Women Based on Nutrigenomic Approach
- ClinicalTrials.gov ID
- NCT07855198
- Acronym / sponsor ID
- N202605084
- Conditions
- Gene Expression, Nutrigenomics
- Keywords
- pine bark extract, Postmenopausal women, antioxidant, Anti-inflammatory, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- QWB
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Oct 2026 (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 clinical trial is to investigate whether French maritime pine bark extract (FMPBE) supplementation can improve antioxidant capacity and reduce inflammation in postmenopausal women aged 40-75 years.
The main questions it aims to answer are:
Does FMPBE supplementation improve antioxidant status and reduce oxidative stress? Does FMPBE supplementation reduce inflammatory responses and affect related gene expression? Researchers will compare an FMPBE treatment group with a placebo group. Participants will take one capsule daily for 30 days and undergo blood collection on Day 0 and Day 30 for biochemical and gene expression analyses. Participants will also complete assessments of anthropometric measurements, blood pressure, dietary intake, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| French maritime pine bark extract | Experimental | Dietary Supplement: French maritime pine bark extractDietary supplement: French maritime pine bark extract(contains sesamin 100 mg per capsule) This group will be given supplements for 30 days. |
| Placebo Comparator: placebo | Placebo comparator | Other: PlaceboPlacebo treatment ( identical capsules containing maltodextrin and magnesium stearate) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women aged 40-75 years.
- Free from chronic diseases and not taking regular medications.
Key exclusion criteria (3 listed)
- Individuals with chronic diseases.
- Individuals with known allergies to the study materials.
- Individuals currently taking nutritional supplements that may interfere with the study outcomes.
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 |
|---|---|---|
| French maritime pine bark extractparticipants who meet the inclusion criteria will be randomly divided into Placebo (P) and treatment (T) groups. Participants in the P group will be provided with one capsule of placebo without FMPBE whereas participants in the T group will be provided with one capsule of placebo with FMPBE (100mg) per day for 30 days. Blood samples will be collected on Day 0 and Day 30 for biochemical and genetic analyses, accompanied by the administration of a quality-of-life (QoL) questionnaire to assess participants' overall well-being. At the same time, they will accept the measurement of anthropometric measurements and blood pressure, also be interviewed with 24 hours dietary recall questionnaire. | Dietary supplement | French maritime pine bark extract |
| Placeboparticipants who meet the inclusion criteria will be randomly divided into Placebo (P) and treatment (T) groups. Participants in the P group will be provided with one capsule of placebo without FMPBE whereas participants in the T group will be provided with one capsule of placebo with FMPBE (100mg) per day for 30 days. Blood samples will be collected on Day 0 and Day 30 for biochemical and genetic analyses, accompanied by the administration of a quality-of-life (QoL) questionnaire to assess participants' overall well-being. At the same time, they will accept the measurement of anthropometric measurements and blood pressure, also be interviewed with 24 hours dietary recall questionnaire. | Other | Placebo Comparator: placebo |
Primary outcome
Change from Baseline quality-of-life (QoL) in 30 days
Time frame: At the start of the experiment and at the Day 30
Quality of life will be assessed using the Menopause-specific Quality of Life (MENQOL) questionnaire, consisting of 53 items. Each item is scored on a 6-point scale from 1 to 6, with higher scores indicating better quality of life. The total score ranges from 53 to 318, with higher total scores indicating better quality of life. The questionnaire assesses menopause-related symptoms and disturbances experienced during the preceding 1-month period.
Antioxidative status
Time frame: At baseline and Day 30
Change from baseline in plasma thiobarbituric acid-reactive substances (TBARS) concentration at Day 30.Plasma TBARS concentration will be measured as an indicator of lipid peroxidation and oxidative stress. The concentration will be reported in nmol/ml.
Antioxidative status
Time frame: At the start of the experiment and at the Day 30
Change from baseline in erythrocytic reduced glutathione-to-oxidized glutathione ratio (GSH/GSSG ratio) at Day 30.The ratio of reduced glutathione (GSH) to oxidized glutathione (GSSG) in erythrocytes will be calculated as an indicator of cellular redox status. The ratio will be reported as a unitless value.
Antioxidative status
Time frame: At baseline and Day 30
Change from baseline in erythrocytic reduced glutathione (GSH) concentration at Day 30.Erythrocytic reduced glutathione (GSH) concentration will be measured and reported in μmol/g Hb.
Antioxidative status
Time frame: At baseline and Day 30
Change from baseline in plasma reduced glutathione (GSH) concentration at Day 30.Plasma reduced glutathione (GSH) concentration will be measured and reported in µmol/L.
Inflammatory status
Time frame: At the start of the experiment and at the Day 30
Change from baseline in plasma tumor necrosis factor-alpha (TNF-α) concentration at Day 30.Plasma TNF-α concentration will be measured and reported in pg/mL.
Inflammatory status
Time frame: At the start of the experiment and at the Day 30
Change from baseline in plasma interleukin-1 beta (IL-1β) concentration at Day 30.Plasma IL-1β concentration will be measured and reported in pg/mL.
Inflammatory status
Time frame: At the start of the experiment and at the Day 30
Change from baseline in plasma interleukin-6 (IL-6) concentration at Day 30.Plasma IL-6 concentration will be measured and reported in pg/mL.
Inflammatory status
Time frame: At the start of the experiment and at the Day 30
Change from baseline in plasma high-sensitivity C-reactive protein (hsCRP) concentration at Day 30.Plasma hsCRP concentration will be measured and reported in mg/dL.
Anti-inflammatory status
Time frame: At the start of the experiment and at the Day 30
Change from baseline in plasma interleukin-10 (IL-10) concentration at Day 30.Plasma IL-10 concentration will be measured and reported in pg/mL.
Anti-inflammatory status
Time frame: At the start of the experiment and at the Day 30
Change from baseline in plasma transforming growth factor-beta (TGF-β) concentration at Day 30.Plasma TGF-β concentration will be measured and reported in pg/mL.
21 secondary outcomes
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
Antioxidant-related gene expression
Time frame: At the start of the experiment and at the Day 30
Inflammation-related gene expression
Time frame: At the start of the experiment and at the Day 30
Lipid profile
Time frame: At the start of the experiment and at the Day 30
Anthropometric measurements
Time frame: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
Antioxidative enzyme activities
Time frame: At the start of the experiment and at the Day 30
anti-inflammation-related gene expression
Time frame: At the start of the experiment and at the Day 30
Regulatory and Redox-related Gene Expression
Time frame: At the start of the experiment and at the Day 30
Liver function
Time frame: At the start of the experiment and at the Day 30
Kidney function
Time frame: At the start of the experiment and at the Day 30
Hematology
Time frame: At the start of the experiment and at the Day 30
Anthropometric measurements
Time frame: At the start of the experiment and at the Day 30
Anthropometric measurements
Time frame: At the start of the experiment and at the Day 30
Anthropometric measurements
Time frame: At the start of the experiment and at the Day 30
Anthropometric measurements
Time frame: At the start of the experiment and at the Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Related trials for Gene Expression
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Clinical Study of 68Ga-labeled Novel EPHA2 Cyclic Peptides PET/CT for Imaging of Solid Tumors
Solid Tumor Malignancies
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
RecruitingEarly Phase 1
Safety and Dystrophin Expression of SPOT-03 in Duchenne Muscular Dystrophy (DMD) Patients
Duchenne Muscular Dystrophy (DMD)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing French maritime pine bark extract in people with Gene Expression and Nutrigenomics, run by Taipei Medical University.
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 2 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 quality-of-life (QoL) in 30 days (time frame: At the start of the experiment and at the Day 30). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.