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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in SCAG (Sandoz Clinical Assessment-Geriatric) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in SCAG (Sandoz Clinical Assessment-Geriatric) score
时间窗: 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.
次要结局
- Change in Perceived Stress Questionnaire (PSQ) score(Baseline, week 1 and week 4)
- Change in Hamilton Anxiety Rating Scale (HAM-A) score(Baseline, week 1 and week 4)
- Change in thyroid-stimulating hormone (TSH) levels(Baseline and week 4)
- Change in SF-12 Health Survey score(Baseline, week 1 and week 4)
- Change in Body Mass Index (BMI)(Baseline and week 4)
- Change in free thyroxine (FT4) levels(Baseline and week 4)
- Change in Cortisol levels(Baseline, week 1 and week 4)
- Change in body weight(Baseline and week 4)
- Change in liver function tests (AST, ALT, gamma-GT)(Baseline and week 4)
- Change in creatinine levels(Baseline and week 4)
- Change in free triiodothyronine (FT3) levels(Baseline and week 4)