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

Not Applicable

Not yet recruiting

• Conditions: General Anxiety Disorder

• Registration Number: NCT06954038
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Study First Posted: 2025-05-01
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Study Start: 2025-08-01
• Primary Completion: 2026-05
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in SCAG (Sandoz Clinical Assessment-Geriatric) score	Baseline, week 1 and week 4	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.

Secondary Outcome Measures

Name	Time	Method
Change in Perceived Stress Questionnaire (PSQ) score	Baseline, week 1 and week 4	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.
Change in Hamilton Anxiety Rating Scale (HAM-A) score	Baseline, week 1 and week 4	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).
Change in thyroid-stimulating hormone (TSH) levels	Baseline and week 4	Thyroid-stimulating hormone (TSH) levels will be evaluated through blood samples collected at baseline and after 30 days to assess the effect of the intervention on pituitary-thyroid axis activity.
Change in SF-12 Health Survey score	Baseline, week 1 and week 4	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
Change in Body Mass Index (BMI)	Baseline and week 4	BMI (kg/m²) will be calculated from measured weight and height at baseline and after 30 days.
Change in free thyroxine (FT4) levels	Baseline and week 4	Free thyroxine (FT4) levels will be assessed from blood samples taken at baseline and after 30 days in order to monitor thyroid gland function.
Change in Cortisol levels	Baseline, week 1 and week 4	Salivary cortisol assessment: 3 evaluation tests on the day x 3 times (first visit = baseline, after 7 days, after 28 days)
Change in body weight	Baseline and week 4	Body weight (kg) will be measured at baseline and at day 30.
Change in liver function tests (AST, ALT, gamma-GT)	Baseline and week 4	Blood tests will be performed at baseline and after 30 days to monitor liver safety through AST, ALT, and GGT levels (U/L).
Change in creatinine levels	Baseline and week 4	Serum creatinine will be measured at baseline and day 30 to assess renal function.
Change in free triiodothyronine (FT3) levels	Baseline and week 4	Free triiodothyronine (FT3) levels will be assessed through blood samples collected at baseline and after 30 days to evaluate peripheral thyroid hormone activity.