Clinical trial NCT06954038: Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: General Anxiety Disorder
Keywords: Leonurus cardiaca
Herbal extract
Anxiety
SCAG scale
Herbal remedy for GAD
HAM-A
PSQ
SF-12
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Female participants aged 18 to 50 years
* Diagnosis of Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) according to DSM-5 criteria
* Regular menstrual cycles (25-35 days) in the past 6 months
* Presence of PMS symptoms for at least 6 months, confirmed through prospective symptom diary
* No hormonal treatment in the previous 3 months
* Written informed consent obtained

Exclusion Criteria:

* Postmenopausal women, or those 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

Primary outcomes:
measure: Change in SCAG (Sandoz Clinical Assessment-Geriatric) score
timeFrame: Baseline, Day 14 and Day 30
Secondary outcomes:
measure: Change in Perceived Stress Questionnaire (PSQ) score
timeFrame: Baseline, day 14 and day 30
measure: Change in Hamilton Anxiety Rating Scale (HAM-A) score
timeFrame: Baseline, day 14 and day 30
measure: Change in SF-12 Health Survey score
timeFrame: Baseline, day 14 and day 30
measure: Change in body weight
timeFrame: Baseline and Day 30
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and Day 30
measure: Change in liver function tests (AST, ALT, gamma-GT)
timeFrame: Baseline and Day 30
measure: Change in creatinine levels
timeFrame: Baseline and Day 30
measure: Change in thyroid-stimulating hormone (TSH) levels
timeFrame: Baseline and Day 30
measure: Change in free triiodothyronine (FT3) levels
timeFrame: Baseline and Day 30
measure: Change in free thyroxine (FT4) levels
timeFrame: Baseline and Day 30
Other outcomes:
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