CTRI/2025/02/079862尚未招募4 期
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Melostacio Gold (Pistachio extract) to Manage Stress and Improve Sleep Quality in Adults.
Botanic Healthcare Pvt Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean change in stress levels from baseline to the end of the study
研究概览
简要总结
This study aims to evaluate the efficacy of pistachio supplementation in enhancing sleep quality and addressing stress-related biomarkers, filling a critical gap in research by providing evidence for its potential therapeutic role in sleep health and overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 54.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Male and female adults aged between 18 and 54 years.
- •b) Adult subjects who are willing to provide written informed consent to participate in the study.
- •c) Free from psychiatric conditions, with the exception of mild stress.
- •d) Capable of reading and writing in English.
排除标准
- •a) Subjects with insomnia, sleep disorders, or chronic stress.
- •b) Chronic alcoholics consuming more than 2 standard pegs per day.
- •c) Subjects with known hypertension or other cardiovascular diseases.
- •d) Subjects with a history of liver diseases, kidney diseases, psychiatric conditions, epilepsy, or any other relevant medical conditions.
- •f) Subjects currently participating in another clinical trial or who have received any investigational product (IP) within 90 days prior to Visit 1 (Screening).
- •h) Subjects currently taking medications other than oral contraceptives.
- •i) Subjects on hepatotoxic medications, such as antitubercular medications, antiviral medications, or paracetamol.
- •k) Individuals with acute narrow-angle glaucoma, prostate hypertrophy, or any cardiovascular, endocrine, renal, or other chronic diseases that could influence stress or anxiety or restrict normal daily functioning.
- •l) Individuals with any diagnosable mental health disorder in the past 6 months (as assessed by the Mini International Neuropsychiatric Interview 6.0) or those currently taking psychotropic medications or other herbal preparations.
结局指标
主要结局
Mean change in stress levels from baseline to the end of the study
时间窗: Screening/Baseline,Day 14, Day 28
次要结局
- Serum Cortisol levels(Baseline(Day 1) and Day 28)
- hs-CRP levels(Baseline(Day 1) and Day 28)
- Improvement in Quality of Life (QOL) using the SF-36(Baseline(Day 1) and Day 28)
- Subject Global Assessment (SGA)(Day 14 and Day 28)
- Physician Global Assessment (PGA) scores(Day 14 and Day 28)
- Change in weight and BMI(Screening/Baseline, Day 14, Day 28)
- Assessment of the safety of Melostacio Gold through hematological and biological evaluations, including ECG, Complete Blood Count (CBC), Liver Function Tests (LFT), Renal Function Tests (RFT), and Random Blood Sugar (RBS).(Baseline (Day 1) and Day 28)
研究者
Dr S S V V Narasinga Rao
Government Medical College & Government General Hospital (Old RIMSGGH)
研究点 (1)
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