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| ID | Type | Description | Link |
|---|---|---|---|
| Leonurus | Other Identifier | University of Pavia |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Stress Questionnaire (PSQ) score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariangela Rondanelli | Contact | +39 0382381749 | mariangela.rondanelli@unipv.it |
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| Placebo | Dietary Supplement | Participants will receive a placebo capsule identical in appearance to the active supplement, administered twice daily for 30 consecutive days. |
|
| 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. |
|
| Baseline, week 1 and week 4 |
| Change in Hamilton Anxiety Rating Scale (HAM-A) score | 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). | Baseline, week 1 and week 4 |
| Change in SF-12 Health Survey score | 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 | Baseline, week 1 and week 4 |
| Change in body weight | Body weight (kg) will be measured at baseline and at day 30. | Baseline and week 4 |
| Change in Body Mass Index (BMI) | BMI (kg/m²) will be calculated from measured weight and height at baseline and after 30 days. | Baseline and week 4 |
| Change in liver function tests (AST, ALT, gamma-GT) | Blood tests will be performed at baseline and after 30 days to monitor liver safety through AST, ALT, and GGT levels (U/L). | Baseline and week 4 |
| Change in creatinine levels | Serum creatinine will be measured at baseline and day 30 to assess renal function. | Baseline and week 4 |
| Change in thyroid-stimulating hormone (TSH) levels | 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. | Baseline and week 4 |
| Change in free triiodothyronine (FT3) levels | Free triiodothyronine (FT3) levels will be assessed through blood samples collected at baseline and after 30 days to evaluate peripheral thyroid hormone activity. | Baseline and week 4 |
| Change in free thyroxine (FT4) levels | Free thyroxine (FT4) levels will be assessed from blood samples taken at baseline and after 30 days in order to monitor thyroid gland function. | Baseline and week 4 |
| Change in Cortisol levels | Salivary cortisol assessment: 3 evaluation tests on the day x 3 times (first visit = baseline, after 7 days, after 28 days) | Baseline, week 1 and week 4 |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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