A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PistamelTM to Manage Stress and Improve Sleep Quality in Adults.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a randomized, double-blind, parallel, placebo-controlled interventional study designed to evaluate the safety and efficacy of Pistamel™ in managing stress and improving sleep quality in healthy adults aged 18–54 years. A total of 40 eligible subjects will be randomized in a 1:1 ratio to receive either Pistamel™ (100 mg capsule once daily after dinner) or a matching placebo (cyclodextrin) for 28 days.
The primary objective is to assess improvement in sleep quality using objective daily sleep diary parameters and subjective sleep quality measured by the Athens Insomnia Scale (AIS). Secondary objectives include evaluation of stress reduction through serum cortisol levels, changes in inflammatory marker hs-CRP, improvement in quality of life using the SF-36 questionnaire, global health assessment using SGA/PGA scores, changes in body weight and BMI, and overall safety and tolerability.
Safety assessments include monitoring of adverse events, clinical evaluations, vital signs, and laboratory investigations (CBC, LFT, RFT, ECG, and RBS) at baseline and study completion. The study includes a screening visit, baseline visit, mid-study follow-up, and a final visit over a total duration of 28 days. Statistical analyses will compare changes within and between groups using appropriate parametric or non-parametric tests, with significance set at p < 0.05.
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
- •1.Male and female adults aged 18–54 years 2.Willing to provide written informed consent 3.Free from psychiatric conditions (except mild stress) 4.Able to read and write in English.
排除标准
- •1.Chronic alcoholics ( greater than 2 standard drinks per day) 2.Known cardiovascular disease, hypertension, liver or kidney disease 3.History of epilepsy, psychiatric conditions, or other significant medical conditions 4.Pregnant, lactating, or attempting to conceive 5.Currently participating in another clinical trial or received investigational product within 90 days 6.Taking medications other than oral contraceptives or hepatotoxic drugs (e.g., antitubercular, antiviral, paracetamol) 7.Acute narrow-angle glaucoma, prostate hypertrophy, or other chronic diseases affecting stress, sleep, or daily functioning 8.Diagnosable mental health disorder in the past 6 months or current use of psychotropic or herbal medication.
研究者
Dr Gurudev S
Gurudev Clinic