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Not yet recruiting NCT06954038

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

No phase Interventional General Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Leonurus cardiaca extract 250 mg, Placebo, Leonurus cardiaca extract 500 mg.
Who it may be relevant to
Registry conditions: General Anxiety Disorder. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

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

Primary outcome measures

  • Change in SCAG (Sandoz Clinical Assessment-Geriatric) score [Time frame: Baseline, week 1 and week 4]
Secondary outcome measures (11)
  • Change in Perceived Stress Questionnaire (PSQ) score [Time frame: Baseline, week 1 and week 4]
  • Change in Hamilton Anxiety Rating Scale (HAM-A) score [Time frame: Baseline, week 1 and week 4]
  • Change in SF-12 Health Survey score [Time frame: Baseline, week 1 and week 4]
  • Change in body weight [Time frame: Baseline and week 4]
  • Change in Body Mass Index (BMI) [Time frame: Baseline and week 4]
  • Change in liver function tests (AST, ALT, gamma-GT) [Time frame: Baseline and week 4]
  • Change in creatinine levels [Time frame: Baseline and week 4]
  • Change in thyroid-stimulating hormone (TSH) levels [Time frame: Baseline and week 4]
  • Change in free triiodothyronine (FT3) levels [Time frame: Baseline and week 4]
  • Change in free thyroxine (FT4) levels [Time frame: Baseline and week 4]
  • Change in Cortisol levels [Time frame: Baseline, week 1 and week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06954038 · 2312/01092024 · Leonurus

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗