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

Azienda di Servizi alla Persona di Pavia

Status: Begins enrollment in 4 months

Conditions: General Anxiety Disorder

Treatments: Dietary Supplement: Leonurus cardiaca extract 500 mg; Dietary Supplement: Placebo; Dietary Supplement: Leonurus cardiaca extract 250 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06954038

Leonurus (Other Identifier)

2312/01092024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Leonurus 250 mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Leonurus cardiaca extract 250 mg

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive a placebo identical in appearance to the active supplement, taken once daily in the morning for 30 days.

Treatment:

Dietary Supplement: Placebo

Leonurus 500 mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Leonurus cardiaca extract 500 mg