Parenting AnxietyParentSOSNCT07828548
Effect of the Ansileve Supplement on the Well-being of Parents of Children Who Have Experienced a Medical Emergency: A Randomized Controlled Study
A study testing Ansileve SOS Spray and Ansileve in people with Parenting Anxiety and Child Hospitalization, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether the dietary supplement Ansileve (Ansileve SOS spray and Ansileve capsules) can improve psychological well-being and parental functioning in mothers and fathers of children experiencing an acute medical event requiring… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting Anxiety, Child Hospitalization, Psychological Well-being
- What is being tested?
- Ansileve SOS Spray and Ansileve
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers and fathers of children presenting to the Pediatria Immunoreumatologia Unit of the De Marchi Pediatric Clinic for an acute medical event
- Age ≥18 years
- Provision of written informed consent
Who cannot join
- Known psychiatric disorders
- Failure to provide written informed consent
- Insufficient proficiency in the Italian language
- Pregnancy or breastfeeding
- Known allergy or intolerance to one or more components of the food supplement
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Silvia Bettocchi contact
About this study
Official title: Effetto Dell'Integratore Ansileve Sul Funzionamento Genitoriale in Soggetti Esposti a un Evento Emergenziale Per il Bambino: Studio Randomizzato Controllato
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether the dietary supplement Ansileve (Ansileve SOS spray and Ansileve capsules) can improve psychological well-being and parental functioning in mothers and fathers of children experiencing an acute medical event requiring hospital care.
The main questions are:
Read more
- Does acute administration of Ansileve SOS spray improve maternal functioning in the short term, as measured by the Barkin Index of Maternal Functioning (BIMF), compared with placebo?
- Does Ansileve SOS spray and the subsequent 30-day supplementation with Ansileve capsules reduce anxiety symptoms and improve emotional well-being in parents, compared with placebo?
Researchers will compare participants receiving Ansileve SOS spray and/or Ansileve capsules with participants receiving matching placebo products to determine whether the intervention improves parental functioning, reduces anxiety symptoms, and supports psychological recovery after a stressful event involving their child.
Participants will:
- Be mothers and fathers (≥18 years) of children admitted for an acute medical event at the Pediatria Immunoreumatologia Unit of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Complete validated questionnaires assessing functioning (BIMF, only mothers), emotional impact of the event [Impact of Event Scale - Revised (IES-R)], and anxiety symptoms [Generalized Anxiety Disorder Scale (GAD-7)] at baseline and during follow-up
- Receive either Ansileve SOS spray or placebo spray at study enrolment.
- Take either Ansileve capsules or placebo capsules daily for 30 days according to the assigned treatment group
- Complete a follow-up assessment to evaluate treatment adherence and possible adverse events.
- Being tested
- Ansileve SOS Spray, Ansileve
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ansileve SOS SprayDietary supplement
Dietary supplement in spray containing Ashwagandha, Hawthorn, Hemp seed oil, and Lavender, known to promote relaxation and support emotional balance. It will be administered as 4 sprays under the tongue, three times daily.
AnsileveDietary supplement
Dietary supplement in capsule form combining plant extracts of Melissa officinalis and Griffonia simplicifolia, B-group vitamins, and hydrolyzed marine peptides. Two capsules will be administered daily, away from meals.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Ansileve SOS Spray + Ansileve Capsules | Active comparator | Not described Receives: Dietary Supplement: Ansileve SOS Spray; Dietary Supplement: Ansileve |
| Arm 2: Ansileve SOS Spray + Placebo Capsules | Other | Not described Receives: Dietary Supplement: Ansileve SOS Spray |
| Arm 3: Placebo Spray + Ansileve Capsules | Other | Not described Receives: Dietary Supplement: Ansileve |
| Arm 4: Placebo Spray + Placebo Capsules | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning.
Change in maternal functioning after spray administration, measured by the change in BIMF questionnaire score, comparing the Ansileve SOS Spray group with the placebo spray group.
Measured: From baseline (T0) to 30 minutes after spray administration (T1).
Secondary outcomes (3)
Short-term change in emotional impact and anxiety symptoms after Ansileve SOS Spray in parents.
Comparison of changes in scores for the emotional impact of the traumatic event and anxiety symptoms between Ansileve SOS Spray and placebo groups, measured using validated questionnaires (IES-R and GAD-7).
Measured: From baseline (T0) to 30 minutes after spray administration (T1).
Long-Term Effects of Ansileve Capsules on Anxiety Symptoms in Parents.
Comparison of changes in GAD-7 anxiety scores after capsule administration between the Ansileve capsule group and the placebo capsule group.
Measured: From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
Combined effects of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms in parents
Evaluation of the combined effect of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms by comparing changes in GAD-7 scores between the active combination group and the placebo group.
Measured: From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting AnxietyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Fondazione De Marchi, University of Calabria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828548
- Sponsor's protocol ID
- ParentSOS
- Other IDs
- 7192_15.07.2026_P_bis
- Acronym
- ParentSOS
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effetto Dell'Integratore Ansileve Sul Funzionamento Genitoriale in Soggetti Esposti a un Evento Emergenziale Per il Bambino: Studio Randomizzato Controllato
- ClinicalTrials.gov ID
- NCT07828548
- Acronym / sponsor ID
- ParentSOS / ParentSOS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- University of Milan, Fondazione De Marchi, University of Calabria
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Sep 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 randomized, double-blind, placebo-controlled clinical trial is to evaluate whether the dietary supplement Ansileve (Ansileve SOS spray and Ansileve capsules) can improve psychological well-being and parental functioning in mothers and fathers of children experiencing an acute medical event requiring hospital care.
The main questions are:
- Does acute administration of Ansileve SOS spray improve maternal functioning in the short term, as measured by the Barkin Index of Maternal Functioning (BIMF), compared with placebo?
- Does Ansileve SOS spray and the subsequent 30-day supplementation with Ansileve capsules reduce anxiety symptoms and improve emotional well-being in parents, compared with placebo?
Researchers will compare participants receiving Ansileve SOS spray and/or Ansileve capsules with participants receiving matching placebo products to determine whether the intervention improves parental functioning, reduces anxiety symptoms, and supports psychological recovery after a stressful event involving their child.
Participants will:
- Be mothers and fathers (≥18 years) of children admitted for an acute medical event at the Pediatria Immunoreumatologia Unit of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Complete validated questionnaires assessing functioning (BIMF, only mothers), emotional impact of the event [Impact of Event Scale - Revised (IES-R)], and anxiety symptoms [Generalized Anxiety Disorder Scale (GAD-7)] at baseline and during follow-up
- Receive either Ansileve SOS spray or placebo spray at study enrolment.
- Take either Ansileve capsules or placebo capsules daily for 30 days according to the assigned treatment group
- Complete a follow-up assessment to evaluate treatment adherence and possible adverse events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Ansileve SOS Spray + Ansileve Capsules | Active comparator | Dietary Supplement: Ansileve SOS Spray, Dietary Supplement: Ansileve |
| Arm 2: Ansileve SOS Spray + Placebo Capsules | Other | Dietary Supplement: Ansileve SOS Spray |
| Arm 3: Placebo Spray + Ansileve Capsules | Other | Dietary Supplement: Ansileve |
| Arm 4: Placebo Spray + Placebo Capsules | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mothers and fathers of children presenting to the Pediatria Immunoreumatologia Unit of the De Marchi Pediatric Clinic for an acute medical event
- Age ≥18 years
- Provision of written informed consent
Key exclusion criteria (5 listed)
- Known psychiatric disorders
- Failure to provide written informed consent
- Insufficient proficiency in the Italian language
- Pregnancy or breastfeeding
- Known allergy or intolerance to one or more components of the food supplement
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 |
|---|---|---|
| Ansileve SOS SprayDietary supplement in spray containing Ashwagandha, Hawthorn, Hemp seed oil, and Lavender, known to promote relaxation and support emotional balance. It will be administered as 4 sprays under the tongue, three times daily. | Dietary supplement | Arm 1: Ansileve SOS Spray + Ansileve Capsules, Arm 2: Ansileve SOS Spray + Placebo Capsules |
| AnsileveDietary supplement in capsule form combining plant extracts of Melissa officinalis and Griffonia simplicifolia, B-group vitamins, and hydrolyzed marine peptides. Two capsules will be administered daily, away from meals. | Dietary supplement | Arm 1: Ansileve SOS Spray + Ansileve Capsules, Arm 3: Placebo Spray + Ansileve Capsules |
Primary outcome
Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning.
Time frame: From baseline (T0) to 30 minutes after spray administration (T1).
Change in maternal functioning after spray administration, measured by the change in BIMF questionnaire score, comparing the Ansileve SOS Spray group with the placebo spray group.
3 secondary outcomes
Short-term change in emotional impact and anxiety symptoms after Ansileve SOS Spray in parents.
Time frame: From baseline (T0) to 30 minutes after spray administration (T1).
Long-Term Effects of Ansileve Capsules on Anxiety Symptoms in Parents.
Time frame: From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
Combined effects of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms in parents
Time frame: From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
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 18 Sep 2026.
- 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.
Silvia Bettocchi contact
Questions about this trial
What is this clinical trial studying?
A study testing Ansileve SOS Spray and Ansileve in people with Parenting Anxiety and Child Hospitalization, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
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 5 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 18 Sep 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. 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?
Contact Cristiana Berti (+39 02 55034338, cristiana.berti@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning. (time frame: From baseline (T0) to 30 minutes after spray administration (T1).). 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 Sep 2026.