An interventional study of Ansileve SOS Spray and Ansileve in Parenting Anxiety, Child Hospitalization and Psychological Well-being, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Supportive care
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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:
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:
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 96 is below the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 234 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Ansileve SOS Spray · Dietary Supplement: Ansileve
Dietary Supplement: Ansileve SOS Spray
Dietary Supplement: Ansileve
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.
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.
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.
Time frame: From baseline (T0) to 30 minutes after spray administration (T1).
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).
Time frame: 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.
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
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.
Time frame: From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Nov 2027, 14 months later.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 14 months is below that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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