General Anxiety Disorder
Conditions
Keywords
Leonurus cardiaca, Herbal extract, Anxiety, SCAG scale, Herbal remedy for GAD, HAM-A, PSQ, SF-12
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.
Interventions
DIETARY_SUPPLEMENTLeonurus 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_SUPPLEMENTPlacebo
Participants will receive a placebo capsule identical in appearance to the active supplement, administered twice daily for 30 consecutive days.
DIETARY_SUPPLEMENTLeonurus 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.
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCAG (Sandoz Clinical Assessment-Geriatric) score | Baseline, week 1 and week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Anxiety Rating Scale (HAM-A) score | Baseline, week 1 and week 4 | 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). |
| Change in SF-12 Health Survey score | Baseline, week 1 and week 4 | 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 |
| Change in body weight | Baseline and week 4 | Body weight (kg) will be measured at baseline and at day 30. |
| Change in Body Mass Index (BMI) | Baseline and week 4 | BMI (kg/m²) will be calculated from measured weight and height at baseline and after 30 days. |
| Change in liver function tests (AST, ALT, gamma-GT) | Baseline and week 4 | Blood tests will be performed at baseline and after 30 days to monitor liver safety through AST, ALT, and GGT levels (U/L). |
| Change in Perceived Stress Questionnaire (PSQ) score | Baseline, week 1 and week 4 | 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. |
| Change in thyroid-stimulating hormone (TSH) levels | Baseline and week 4 | 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. |
| Change in free triiodothyronine (FT3) levels | Baseline and week 4 | Free triiodothyronine (FT3) levels will be assessed through blood samples collected at baseline and after 30 days to evaluate peripheral thyroid hormone activity. |
| Change in free thyroxine (FT4) levels | Baseline and week 4 | Free thyroxine (FT4) levels will be assessed from blood samples taken at baseline and after 30 days in order to monitor thyroid gland function. |
| Change in Cortisol levels | Baseline, week 1 and week 4 | Salivary cortisol assessment: 3 evaluation tests on the day x 3 times (first visit = baseline, after 7 days, after 28 days) |
| Change in creatinine levels | Baseline and week 4 | Serum creatinine will be measured at baseline and day 30 to assess renal function. |
Contacts
Primary ContactMariangela Rondanelli
Outcome results
None listed