Clinical Trial

Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety

Study acronym: LEONORUS
Not Yet Recruiting
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Record status
This record was last updated November 25, 2025 (before its estimated July 15, 2026 completion). Its status may not reflect the trial's current state.
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 years with a diagnosis of GAD will be randomly assigned to receive either Leonurus cardiaca extract or placebo for 30 days. The primary outcome is the reduction in anxiety symptoms assessed by the SCAG scale. Secondary outcomes include changes in quality of life (SF-12), perceived stress (PSQ), anxiety severity (HAM-A), and anthropometric measures. Safety will be assessed through liver, kidney, and thyroid function tests. Assessments will be conducted at baseline, day 14, and day 30.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-24; most recent amendment 2025-11-23.
Trial Details
NCT Number NCT06954038
Lead Sponsor Azienda di Servizi alla Persona di Pavia
Conditions General Anxiety Disorder
Enrollment 60 participants
Start Date 2026-06-15
Primary Completion 2026-07-15 (estimated)
Study Completion 2026-09-15 (estimated)
Updated on ClinicalTrials.gov 2025-11-25