A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Effect of Multi-herb Formulae VL-G-A57 and an Ashwagandha Root Formula (VL-G-E12) on the Modulation of the Hypothalamic-pituitary-adrenal Axis (HPA Axis) and Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 5
- 主要终点
- Perceived stress scale
研究概览
简要总结
Two unique proprietary formulations of adaptogens VL-G-E12 formulation and an herbal blend containing VL-G-A57 is one of the most well-known adaptogens that has been used for years to enhance positive mood states, deepen sleep, and improve memory. The product has been proven to have a role in improving depression, enhancing work performance, eliminating fatigue and treating symptoms of asthenia subsequent to intense physical and psychological stress. The extract was tested on antidepressant, adaptogenic, anxiolytic, nociceptive and locomotor activities at doses of 10, 15 and 20 mg/kg, using predictive behavioral tests and animal models. The results show that this product extract significantly, but not dose-dependently, induced antidepressant-like, adaptogenic, anxiolytic-like and stimulating effects in mice. Studies reveal that this shrub has antimicrobial (including antibacterial, antiviral, antifungal, antiprotozoal, antimalarial, anthelmintic), anti-inflammatory, anti-diabetic, anti-hypercholesterolemia, anti-hypertensive, anti-carcinogenic, and immunomodulatory effect.The aim of the current study is to assess the adaptogenic effects of two potential investigational products VL-G-A57 and VL-G-E12 Their adaptogenic effect shall be investigated by assessing several clinical symptoms of HPA axis dysfunction such as stress, anxiety, sleep quality, fatigue, mood etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
A randomized, placebo-controlled, double-blind study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects ≥18 and ≤ 65 years' old with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
- •BMI: 18 to 29.9 kg/m2
- •RSQ-W (Restorative Sleep Questionnaire-weekly version) score less than or equal to 50
- •PSS scores ranging from 27-40
- •All participants will be encouraged to not make any major lifestyle changes during the study period.
- •They will be informed that any major changes may result in exclusion from the study.
- •Participants willing to provide written informed consent.
排除标准
- •Subjects with a medical history of heart disease, respiratory disorders, metabolic or lifestyle disorders, seizure disorders, or other chronic health conditions requiring medication were excluded.
- •Individuals who currently, or in the past 6 months suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 5.0.01 ) or were taking apsychotropic medication or other herbal preparation were also excluded from participating in the study.
- •Subjects with a blood pressure range of systolic ≥ 140 mm Hg and diastolic ≥ 90 mm Hg.
- •Subjects on any sleep medication since last 3 months
- •Subjects with a history of severe intrinsic sleep related disorders.
- •Subjects who have taken Ashwagandha or any sleep or other supplements within the last three months,
- •People with a known hypersensitivity to Ashwagandha
- •Subjects who work on a night shift
- •Nursing or pregnant women
研究组 & 干预措施
VL-G-A57
Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
干预措施: VL-G-A57 (Other)
VL-G-E12
Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
干预措施: VL-G-E12 (Other)
Placebo
Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
干预措施: Placebo (Other)
结局指标
主要结局
Perceived stress scale
时间窗: Day 60
To assess the impact of the Investigational Product (IP) on stress levels by using the Perceived stress scale (PSS)from baseline. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Perceived stress scale
时间窗: Day 0
To assess the impact of the Investigational Product (IP) on stress levels by using the Perceived stress scale (PSS)from baseline. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Perceived stress scale
时间窗: Day 30
To assess the impact of the Investigational Product (IP) on stress levels by using the Perceived stress scale (PSS)from baseline. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
次要结局
- Morning Salivary Cortisol(Day 0, 30 and 60)
- Impact of the IP on the Mental alertness(Day 0, 30 and 60)
- Fatigue Severity Scale(Day 0, 30 and 60)
- Restorative sleep questionnaire(Day 0, 30 and 60)
- Adrenocorticotropic Hormone (ACTH) in plasma(Day 0, 30 and 60)
- Pittsburgh Sleep Quality Index.(Day 0, 30 and 60)
- Depression, Anxiety, Stress Scale-21(Day 0, 30 and 60)