CTRI/2024/11/077454尚未招募Phase 3 4
A Randomized, Double-Blind, Active-Controlled, Cross-over, Clinical Study to Evaluate the Efficacy and Safety of ThymoDream(TM) in healthy volunteers with poor sleep quality.
Akay Natural Ingredients Private Limited1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年12月9日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean change in the following parameters in ThymoDreamâ„¢ arm compared to melatonin from baseline to end of treatment (EOT):
研究概览
简要总结
| This is a randomized (1:1), double-blind, two arm, active-controlled, cross-over clinical study. Healthy adult subjects with sleep complaints, aged 18-70 years meeting all inclusion and no exclusion criteria will be enrolled in the study. After the informed consent process, demographic details, medical history and medication history will be obtained. After passing the eligibility criteria, subjects will be randomized into one of the 2 treatment arms to receive Investigation products (IP), ThymoDream™ or melatonin in 1:1 ratio. The randomized IP will be consumed half an hour before the usual bedtime at night for 7 days. There will be 2 treatment periods. After the first treatment period, subjects will undergo a washout period of 1 week following which they will undergo cross-over of treatment. Prior to initiation of treatment, the eligible subjects will enter a pre-treatment phase (when no IP will be consumed) and will be housed at the study site for 3 days for baseline assessments (Day -2, Day -1). Subjects will be discharged after the randomized IP initiation and Day 1 actigraphy assessment. Melatonin profiling will be performed on baseline and end of the study on each period. The subject’s housing at the study site will be repeated on Day 3, Day 6 and Day 7 for each treatment period. Subjects will be scheduled to sleep and wake at their habitual pre-study sleep wake times . |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Pittsburgh Sleep Quality Index (PSQI) scores between 5-15
- •Can read and write English.
- •No history of psychiatric conditions
- •Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages.
- •Should be ready to be housed during the study as per the protocol requirement.
- •Should be willing to adhere with their routine diet and exercise regimen throughout the study.
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Subject suffering from mental disorders, clinical anxiety, depression, Cushing’s syndrome and other major ailments.
- •2.Subjects on medication/dietary supplements that may affect the measured responses, including medicines for sleep disorders, anxiety, depression; prednisone, dexamethasone and other steroids administered orally or intravenous 3.Alcohol addicts, smokers of more than 10 cigarettes/day.
- •4.Pregnant and lactating women 5.Subjects on hormonal birth-control measures 6.Subjects currently on any medication on a regular basis.
- •7.Subjects allergic to herbal products, nuts or any component of the study product 8.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change in the following parameters in ThymoDreamâ„¢ arm compared to melatonin from baseline to end of treatment (EOT):
时间窗: Baseline and Day 7
- Melatonin profiling
时间窗: Baseline and Day 7
- Biomarkers
时间窗: Baseline and Day 7
次要结局
- Mean change in the following parameters in ThymoDream™ arm compared to melatonin from baseline to EOT:(•Wrist actigraphy parameters:)
- Safety Parameters(Baseline, Day 3, Day 6)
研究者
Dr Harshith CS
BGS Global Institute of Medical Sciences
研究点 (1)
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