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

N/ANot Yet RecruitingNCT06954038

Azienda di Servizi alla Persona di Pavia60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

General Anxiety Disorder

Interventions

Leonurus cardiaca extract 500 mgDIETARY_SUPPLEMENT

Participants will receive a dietary supplement containing 500 mg of Leonurus cardiaca extract formulated in phospholipids. The supplement is administered as a single oral capsule, once daily in the morning, for 30 consecutive days.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

Change in SCAG (Sandoz Clinical Assessment-Geriatric) score

Anxiety and neurovegetative symptoms will be assessed using the SCAG scale at baseline, 14 days, and 30 days. The SCAG includes items scored from 0 (absent) to 4 (very severe), providing a composite measure of mood, anxiety, headache, and sleep quality.

Time frame: Baseline, week 1 and week 4

Secondary Outcomes

Change in Perceived Stress Questionnaire (PSQ) score

Stress perception will be assessed across four domains (worries, tension, joy, and demands) using the PSQ ( Perceived Stress Questionnaire), a 14-item survey. The total score ranges from a minimum of 0 to a maximum of 56. Higher scores on the scale indicate higher perceived stress and generally reflect a worse outcome in terms of stress-related well-being.

Time frame: Baseline, week 1 and week 4

Change in Hamilton Anxiety Rating Scale (HAM-A) score

The severity of anxiety symptoms will be evaluated using the HAM-A scale, which consists of 14 items each scored from 0 to 4. Total score ranges from 0 (no anxiety) to 56 (severe anxiety).

Time frame: Baseline, week 1 and week 4

Change in SF-12 Health Survey score

The Short Form Health Survey (SF-12) will be used to evaluate physical and mental well-being. Two summary scores (Physical and Mental Component) will be analyzed. It measures health status through summary scores for the physical (PCS-12) and mental (MCS-12) components. PCS-12 and MCS-12 summary scores are standardised to have mean 50 and standard deviation 10 in the general US population

Time frame: Baseline, week 1 and week 4

Change in body weight

Body weight (kg) will be measured at baseline and at day 30.