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

NCT06954038 | Not Yet Recruiting

• 2 other identifiers: 2312/01092024Leonurus
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

General Anxiety Disorder

Keywords

Leonurus cardiaca; Herbal extract; Anxiety; SCAG scale; Herbal remedy for GAD; HAM-A; PSQ; SF-12

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Perceived Stress Questionnaire (PSQ) score

  Baseline, week 1 and week 4

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

  Baseline, week 1 and week 4

• Change in SF-12 Health Survey score

  Baseline, week 1 and week 4

• Change in body weight

  Baseline and week 4

• Change in Body Mass Index (BMI)

  Baseline and week 4

Study Arms (3)

Leonurus 250 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Leonurus 500 mg

EXPERIMENTAL

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

Interventions

Leonurus cardiaca extract 250 mg DIETARY_SUPPLEMENT

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.

Leonurus 250 mg

Placebo DIETARY_SUPPLEMENT

Participants will receive a placebo capsule identical in appearance to the active supplement, administered twice daily for 30 consecutive days.

Placebo

Leonurus cardiaca extract 500 mg DIETARY_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.

Leonurus 500 mg

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Mariangela Rondanelli

CONTACT

+39 0382381749; mariangela.rondanelli@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share