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

A Randomized, Double Dummy, Placebo-controlled Pilot Study to Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety

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 Overview

• Status: Not yet recruiting
• Conditions: General Anxiety Disorder
• Intervention / Treatment: Dietary supplement: Leonurus cardiaca extract 250 mg; Dietary supplement: Placebo; Dietary supplement: Leonurus cardiaca extract 500 mg

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariangela Rondanelli; Phone Number: +39 0382381749; Email: mariangela.rondanelli@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants in this arm will receive a placebo identical in appearance to the active supplement, taken once daily in the morning for 30 days.	Dietary supplement: Placebo; Participants will receive a placebo capsule identical in appearance to the active supplement, administered twice daily for 30 consecutive days.
Experimental: Leonurus 250 mg; Participants in this arm will receive a standardized oral supplement containing 250 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days.	Dietary supplement: Leonurus cardiaca extract 250 mg; Participants will receive a dietary supplement containing 250 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.
Experimental: Leonurus 500 mg; Participants in this arm will receive a standardized oral supplement containing 500 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days.	Dietary supplement: Leonurus cardiaca extract 500 mg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, week 1 and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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	Baseline, week 1 and week 4
Change in body weight	Body weight (kg) will be measured at baseline and at day 30.	Baseline and week 4
Change in Body Mass Index (BMI)	BMI (kg/m²) will be calculated from measured weight and height at baseline and after 30 days.	Baseline and week 4
Change in liver function tests (AST, ALT, gamma-GT)	Blood tests will be performed at baseline and after 30 days to monitor liver safety through AST, ALT, and GGT levels (U/L).	Baseline and week 4
Change in creatinine levels	Serum creatinine will be measured at baseline and day 30 to assess renal function.	Baseline and week 4
Change in thyroid-stimulating hormone (TSH) levels	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.	Baseline and week 4
Change in free triiodothyronine (FT3) levels	Free triiodothyronine (FT3) levels will be assessed through blood samples collected at baseline and after 30 days to evaluate peripheral thyroid hormone activity.	Baseline and week 4
Change in free thyroxine (FT4) levels	Free thyroxine (FT4) levels will be assessed from blood samples taken at baseline and after 30 days in order to monitor thyroid gland function.	Baseline and week 4
Change in Cortisol levels	Salivary cortisol assessment: 3 evaluation tests on the day x 3 times (first visit = baseline, after 7 days, after 28 days)	Baseline, week 1 and week 4

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; SF-12; Herbal extract; PSQ; Leonurus cardiaca; SCAG scale; Herbal remedy for GAD; HAM-A
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder
• Other Study ID Numbers: 2312/01092024; Leonurus (Other Identifier: University of Pavia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No