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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorAzienda di Servizi alla Persona di Pavia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Leonurus cardiaca extract 250 mg
  • Placebo
  • Leonurus cardiaca extract 500 mg

Treatment groups

60 Participants
are divided into 3 treatment groups

Locations

This trial has no locations