Healthy VolunteersNCT06059534
Evaluation of the Effects of DracoBelle Nu in Skin Health After Oral Intake
A study testing Dietary supplementation with DracoBelleTM Nu. in people with Healthy Volunteers, run by Bionos Biotech S.L. at 1 site in Spain.
Trial summary
The goal of this clinical trial is to study the effects of DracoBelleTM Nu in different skin parameters associated with age. Volunteers will be asked to take either placebo of DracoBelleTM Nu capsules once a day by oral intake for a total period of 12 weeks. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dietary supplementation with DracoBelleTM Nu.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 19 Oct 2023to 30 Dec 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers.
- Between 35-60 years old (both included).
- With noticeable wrinkles.
- Subjects with absence of any infectious disease within the 4 weeks previous to the study.
- Informed of the purpose and the protocol of the study and signed a written informed-consent form.
Who cannot join
- Diagnosis of any diseases such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease.
- Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females (europa.eu).
- Current smoking habit or history of smoking within the past 1 year.
- History of depression, schizophrenia, alcoholism, drug addiction, or mental illness.
- Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
- History of asthma or autoimmune disease Use of oral hormone therapies ie. cortisone or steroids in the 6 months prior to initiation of the study.
Show all 13Show fewer
- Abnormal liver function or abnormal renal function.
- Blood pressure >140/90 mmHg or hypertension with intake of a diuretic.
- Any condition judged by the investigator to be unsuitable for participation in the study.
- Subjects refrain from the intake of other oral supplements, including antioxidants, dietary supplements, etc.
- Subjects do not alter their mode of contraception 6 weeks prior and during the study.
- Subjects refrain from any intense or invasive cosmetic treatment, alone or by a beautician, such as intense masks, peelings, and other treatments.
- Subjects are free to follow their usual routine of day and night care products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Improvement of Skin Health Parameters After Oral Intake of DracoBelle Nu in Human Volunteers
The goal of this clinical trial is to study the effects of DracoBelleTM Nu in different skin parameters associated with age. Volunteers will be asked to take either placebo of DracoBelleTM Nu capsules once a day by oral intake for a total period of 12 weeks. Several age-associated skin parameters (skin elasticity, firmness, fatigue, wrinkles, roughness, skin density, hydration, pigmentation and barrier effect) will be measured before the treatment and 4, 8 and 12 weeks after the first oral intake. Data of the placebo and DracoBelleTM Nu group will be analyzed to evaluate the effect of the product DracoBelleTM Nu in the selected age-associated skin parameters.
Read the detailed description
Skin aging refers to the natural process of changes that occur in the skin as individuals get older. It is a complex biological process influenced by both intrinsic (internal) and extrinsic (external) factors. The signs of skin aging include wrinkles, loss of elasticity and firmness, loss of skin density, reduced skin hydration, altered skin barrier effect and alterations in skin pigmentation. Recent studies show that the consumption of nutraceuticals may improve different parameters associated with skin aging. Recently, it has been shown that daily food supplementation with 200 mg of Moldavian dragonhead dry extract (DracoBelleTM Nu) improved the skin hydration, elasticity and increased skin density. In this placebo-controlled study, the investigators aim to investigate the effects of dietary supplementation with DracoBelleTM Nu in different skin parameters associated with age.
The products will be provided in capsules containing placebo or 200 mg of DracoBelleTM Nu. 50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day, preferably in the morning) for 12 weeks. Different parameters will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake. The parameters that will be measured are related to the skin health and skin aging and will be determined as follows:
- The skin elasticity, firmness and fatigue will be measured by the Cutometer in the face skin area.
- Wrinkles (area, length, depth and volume) and roughness of the skin will be measured by the technology Bio3D-MS in the crows-feet and cheek areas.
- The skin density will be measured to determine the thickness of the epidermis and dermis by echography analysis with the UltraScan Echograph in the face skin area.
- Skin hydration will be measured with the Corneometer in the face skin area.
- The skin barrier effect will be measured by quantifying the transepidermal water loss with the Tewameter in the cheek.
- The alterations of the skin pigmentation (area and number of dark spots, and contrast of the dark spots compared to the skin) will be measured with the technology Bio3D-MS.
- Conditions
- Healthy Volunteers
- Being tested
- Dietary supplementation with placebo., Dietary supplementation with DracoBelleTM Nu.
- Keywords
- DracoBelleTM Nu, Skin, Aging, Oral, Ingestion, Nutraceutical, Wrinkles, Elasticity, Firmness, Barrier effect, Hydration, Density, Dragonhead, Placebo, Roughness, Fatigue, Pigmentation, Randomized, Blinded
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementation with placebo.Dietary supplement
Volunteers will be provided with the placebo capsules. For each volunteer, different age-associated skin parameters will be measured with specialized equipment before the treatment and 4, 8 and 12 weeks after the first oral intake of the product.
Dietary supplementation with DracoBelleTM Nu.Dietary supplement
Volunteers will be provided with the DracoBelleTM Nu capsules. For each volunteer, different age-associated skin parameters will be measured with specialized equipment before the treatment and 4, 8 and 12 weeks after the first oral intake of the product.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This group will be provided with placebo capsules for comparative purposes. Receives: Dietary Supplement: Dietary supplementation with placebo. |
| DracoBelleTM Nu | Experimental | This group will be provided with DracoBelleTM Nu capsules, which will be compared to the placebo group. Receives: Dietary Supplement: Dietary supplementation with DracoBelleTM Nu. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin elasticity will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.
Measured: Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin firmness will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.
Measured: Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin fatigue will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.
Measured: Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Wrinkles will be measured in the crows feet area with the Bio3D-MS, and the unit of measurement will be arbitrary units.
Measured: Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Roughness will be measured in the crows feet area with the Bio3D-MS, and the unit of measurement will be arbitrary units.
Measured: Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Skin density will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin density will be measured in the face skin area with the UltraScan Echograph, and the unit of measurement will be arbitrary units.
Measured: Skin density will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Skin hydration will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin hydration will be measured in the face skin area with the Corneometer, and the unit of measurement will be arbitrary units.
Measured: Skin hydration will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Skin barrier effect will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin barrier effect will be measured in the face skin area with the Tewameter, and the unit of measurement will be arbitrary units.
Measured: Skin barrier effect will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Skin pigmentation will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin pigmentation will be measured in the face skin area with the Bio3D-MS, and the unit of measurement will be arbitrary units.
Measured: Skin pigmentation will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start19 Oct 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionos Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Pajuelo Gamez, PhD, Principal investigator, Hospital La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059534
- Sponsor's protocol ID
- DracoBelle_2023
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Improvement of Skin Health Parameters After Oral Intake of DracoBelle Nu in Human Volunteers
- ClinicalTrials.gov ID
- NCT06059534
- Acronym / sponsor ID
- DracoBelle_2023
- Conditions
- Healthy Volunteers
- Keywords
- DracoBelleTM Nu, Skin, Aging, Oral, Ingestion, Nutraceutical, Wrinkles, Elasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bionos Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Sep 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.
The goal of this clinical trial is to study the effects of DracoBelleTM Nu in different skin parameters associated with age. Volunteers will be asked to take either placebo of DracoBelleTM Nu capsules once a day by oral intake for a total period of 12 weeks. Several age-associated skin parameters (skin elasticity, firmness, fatigue, wrinkles, roughness, skin density, hydration, pigmentation and barrier effect) will be measured before the treatment and 4, 8 and 12 weeks after the first oral intake. Data of the placebo and DracoBelleTM Nu group will be analyzed to evaluate the effect of the product DracoBelleTM Nu in the selected age-associated skin parameters.
Detailed description
Skin aging refers to the natural process of changes that occur in the skin as individuals get older. It is a complex biological process influenced by both intrinsic (internal) and extrinsic (external) factors. The signs of skin aging include wrinkles, loss of elasticity and firmness, loss of skin density, reduced skin hydration, altered skin barrier effect and alterations in skin pigmentation. Recent studies show that the consumption of nutraceuticals may improve different parameters associated with skin aging. Recently, it has been shown that daily food supplementation with 200 mg of Moldavian dragonhead dry extract (DracoBelleTM Nu) improved the skin hydration, elasticity and increased skin density. In this placebo-controlled study, the investigators aim to investigate the effects of dietary supplementation with DracoBelleTM Nu in different skin parameters associated with age.
The products will be provided in capsules containing placebo or 200 mg of DracoBelleTM Nu. 50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day, preferably in the morning) for 12 weeks. Different parameters will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake. The parameters that will be measured are related to the skin health and skin aging and will be determined as follows:
- The skin elasticity, firmness and fatigue will be measured by the Cutometer in the face skin area.
- Wrinkles (area, length, depth and volume) and roughness of the skin will be measured by the technology Bio3D-MS in the crows-feet and cheek areas.
- The skin density will be measured to determine the thickness of the epidermis and dermis by echography analysis with the UltraScan Echograph in the face skin area.
- Skin hydration will be measured with the Corneometer in the face skin area.
- The skin barrier effect will be measured by quantifying the transepidermal water loss with the Tewameter in the cheek.
- The alterations of the skin pigmentation (area and number of dark spots, and contrast of the dark spots compared to the skin) will be measured with the technology Bio3D-MS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Dietary supplementation with placebo.This group will be provided with placebo capsules for comparative purposes. |
| DracoBelleTM Nu | Experimental | Dietary Supplement: Dietary supplementation with DracoBelleTM Nu.This group will be provided with DracoBelleTM Nu capsules, which will be compared to the placebo group. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy female volunteers.
- Between 35-60 years old (both included).
- With noticeable wrinkles.
- Subjects with absence of any infectious disease within the 4 weeks previous to the study.
- Informed of the purpose and the protocol of the study and signed a written informed-consent form.
Key exclusion criteria (13 listed)
- Diagnosis of any diseases such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease.
- Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females (europa.eu).
- Current smoking habit or history of smoking within the past 1 year.
- History of depression, schizophrenia, alcoholism, drug addiction, or mental illness.
- Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
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 |
|---|---|---|
| Dietary supplementation with placebo.Volunteers will be provided with the placebo capsules. For each volunteer, different age-associated skin parameters will be measured with specialized equipment before the treatment and 4, 8 and 12 weeks after the first oral intake of the product. | Dietary supplement | Placebo |
| Dietary supplementation with DracoBelleTM Nu.Volunteers will be provided with the DracoBelleTM Nu capsules. For each volunteer, different age-associated skin parameters will be measured with specialized equipment before the treatment and 4, 8 and 12 weeks after the first oral intake of the product. | Dietary supplement | DracoBelleTM Nu |
Primary outcome
Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin elasticity will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.
Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin firmness will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.
Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin fatigue will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.
Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Wrinkles will be measured in the crows feet area with the Bio3D-MS, and the unit of measurement will be arbitrary units.
Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Roughness will be measured in the crows feet area with the Bio3D-MS, and the unit of measurement will be arbitrary units.
Skin density will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Skin density will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin density will be measured in the face skin area with the UltraScan Echograph, and the unit of measurement will be arbitrary units.
Skin hydration will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Skin hydration will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin hydration will be measured in the face skin area with the Corneometer, and the unit of measurement will be arbitrary units.
Skin barrier effect will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Skin barrier effect will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin barrier effect will be measured in the face skin area with the Tewameter, and the unit of measurement will be arbitrary units.
Skin pigmentation will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.
Time frame: Skin pigmentation will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.
50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin pigmentation will be measured in the face skin area with the Bio3D-MS, and the unit of measurement will be arbitrary units.
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 18 Jan 2024.
- 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.
David Pajuelo Gamez, PhD principal investigator
Hospital La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplementation with DracoBelleTM Nu. in people with Healthy Volunteers, run by Bionos Biotech S.L. 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 5 inclusion and 13 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 18 Jan 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?
Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake. (time frame: Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.). The study lists 9 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 18 Jan 2024.