A 3-arm Randomised, double-blind, placebo-controlled Study Comparing Griffonia simplicifolia and a Novel Propriety Mushroom Blend on Mood and Sleep Quality Enhancement in Young Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy of mental health as assessed by the change in Depression, Anxiety and Stress Scales-21 items (DASS-21) scores from baseline in comparison to placebo
研究概览
简要总结
In this randomized, double-blind, placebo-controlled study titled "A 3-arm Randomised, double-blind, placebo-controlled Study Comparing Griffonia simplicifolia and a Novel Proprietary Mushroom Blend on Mood and Sleep Quality Enhancement in Young Adults," the primary efficacy outcome revolves around assessing mental health using the Depression, Anxiety, and Stress Scales-21 items (DASS-21). The study aims to compare the change in DASS-21 scores from baseline to placebo, evaluating the efficacy and tolerability of nutritional supplementation with standardized preparations of Griffonia simplicifolia and a novel proprietary mushroom blend. Secondary efficacy outcomes include the evaluation of mood and sleep duration through salivary cortisol levels. Tertiary efficacy outcomes focus on comparing the effects of capsule preparations versus chewable snack bar applications. Safety outcomes encompass the recording of adverse events, drop-outs, compliance rates, and safety parameters such as vital signs and laboratory tests. The study aims to provide a comprehensive understanding of the impact of Griffonia simplicifolia and the novel proprietary mushroom blend on mental health, sleep, and overall well-being in young adults, while ensuring safety through rigorous monitoring and comparisons across groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 32.00 Year(s)（—）
- 性别
- All
入选标准
- •Experiencing any of the following: Feelings of unsettlement, nervousness and/or feeling tense; Feelings of fatigue, weakness and/or tiredness; Feelings of moodiness, irritability and/or restlessness; Lack of concentration, racing thoughts, unwanted thoughts, fear and/or worry; Difficulty concentrating; Difficulty completing tasks and/or lack of motivation; Feelings, thoughts and/or behaviours interfering with the ability to connect/bond with others; Feelings of loneliness and/or withdrawal from social groups; Preference of being alone; Lack of interest in the activities or hobbies usually enjoyed; Changes in sleeping patterns or habits; Morning grogginess; Daytime sleepiness; Difficulty falling or staying asleep; Waking up during the night; Trouble focusing during daytime hours; Participants willing to comply / perform study treatments including saliva sample collection and questionnaires; Participants able to give written informed consent and willingness to participate in the study and comply with respective procedures.
排除标准
- •Prospective participants that are trying to become pregnant, pregnant and or breastfeeding.
- •Prospective participants taking anti depressant.
- •Prospective participants taking monoamine oxidase inhibitors.
- •Prospective participants taking central nervous system.
- •Prospective participants using tobacco and alcohol abuse.
- •Participants with known allergy and or sensitivity to 5 Hydroxytryptrophan from Griffonia simplicifolia.
- •Participants with a known allergy and or sensitivity to the following IP mushrooms.
- •Participants with history of CVD, Participants with auto immune disorders, renal dysfunction, liver dysfunction, Type I & II diabetes, psychiatric disorders.
- •Participants present or history of self harm sucidal thoughts and or ideations.
- •Participants of eating disorder as per DSM
- •Participants with a history of sleep disorders including recurrent insomnia sleep wake disorders obstructive sleep apnea central sleep apnea sleep related hypoventilation parasomnia narcolepsy non rapid eye movement sleep arousal disorders rapid eye movement sleep behavior disorder hyperomnolence disorder nightmare disorder and or restless leg syndrome within the past five years.
- •Any condition that the principal investigator deems precludes the participants ability to successfully and safely complete the study and or that may confound study outcomes.
结局指标
主要结局
Efficacy of mental health as assessed by the change in Depression, Anxiety and Stress Scales-21 items (DASS-21) scores from baseline in comparison to placebo
时间窗: Day 0; Day 13; Day 25;
次要结局
- As assessed by the change in salivary cortisol from baseline in comparison to placebo(Day 0; Day 25;)
- Determine the efficacy and tolerability of the interventions by comparing them with a placebo.(Day 0; Day 13; Day 25;)
研究者
Dr. Santosh Ramdurg
Shri. B. M. Patil Medical College, Hospital & Research Centre