Status:
NOT_YET_RECRUITING
Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety
Lead Sponsor:
Azienda di Servizi alla Persona di Pavia
Conditions:
General Anxiety Disorder
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
This study aims to evaluate the efficacy and safety of Leonurus cardiaca extract in reducing anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). Sixty drug-free participants aged 20-50...
Eligibility Criteria
Inclusion
- Aged 20 to 50 years
- Diagnosis of a generalised anxiety disorder (GAD), with manifestations occurring for \>= 6 months that include excessive worry, poor concentration, restlessness, muscle tension, irritability, fatigue and difficulty sleeping
Exclusion
- Women who are pregnant or breastfeeding
- Use of hormonal contraceptives in the last 3 months
- Current diagnosis of major psychiatric disorders (e.g., major depressive disorder, severe anxiety disorders, schizophrenia, bipolar disorder)
- Known endocrine disorders (e.g., hypothyroidism, hyperthyroidism, diabetes)
- Use of medications that could affect mood or the menstrual cycle (e.g., SSRIs, anxiolytics, antipsychotics)
- Severe hepatic or renal impairment
- Any other serious or unstable medical condition that, in the investigator's judgment, could interfere with study participation
Key Trial Info
Start Date :
June 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06954038
Start Date
June 15 2026
End Date
September 15 2026
Last Update
November 25 2025
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