An Open-Label, Single-Arm, Single-Centered Clinical Study To EvaluateThe Safety And Efficacy Of the Dream Body Cream In Subjects With Sleeplessness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is the improvement in sleep quality from baseline to Day 45, measured using the Pittsburgh Sleep Quality Index (PSQI). A reduction in the PSQI score, which evaluates sleep latency, duration, efficiency, and disturbances, will indicate improved sleep quality.
研究概览
简要总结
**INTRODUCTION AND BACKGROUND:**Sleeplessness, or difficulty falling or staying asleep, affects a significant portion of the adult population and can negatively impact daily life, mood, concentration, and overall health. It can lead to more serious conditions like anxiety, depression, heart disease, and diabetes. Traditional treatments, like sleeping pills, can have side effects and risks. In response, there is growing interest in non-drug treatments for sleeplessness. One such option is the Dream Body Cream (Night Body Cream), a topical product designed to improve both sleep quality and skin health. This cream combines natural ingredients such as Juniper, Marjoram, Roman Chamomile, Sweet Basil, Ylang Ylang, and Cocoa Butter, which are known for their calming and skin-hydrating properties. When applied before bedtime, the cream helps nourish the skin while also promoting relaxation and better sleep. Its dual benefits make it a gentle and effective alternative to traditional sleep medications.
**PURPOSE OF THE STUDY:**The purpose of the study was to evaluate the effectiveness of the Dream Body Cream (Night Body Cream) in improving sleep quality and promoting skin hydration. The study aimed to investigate whether this topical formulation, which contains natural ingredients known for their calming and sleep-enhancing properties, can offer a non-pharmacological alternative to traditional sleep treatments. By assessing both the sleep-improving and skin-nourishing benefits of the cream, the study was conducted to determine whether it provides a holistic solution for individuals experiencing sleeplessness, with fewer side effects compared to conventional medications.
**RESULTS:**The study recruited 28 female and 32 male subjects, who participated in the study from Baseline till EOS with no withdrawals or dropouts. All participants had normal physiological vital signs, including respiratory rate, pulse rate, body temperature and blood pressure. The efficacy of Dream Body Cream was evaluated based on changes in Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 45.
**Primary Endpoint (PSQI)****:**The data highlights significant improvements in sleep efficiency, duration, and quality over four visits with a steady reduction in sleep onset time from 33.67 minutes in Visit 1 to 14.25 minutes in Visit 4., a gradual increase in sleep duration from 5.19 hours to 6.76 hours, reinforcing a positive trend toward longer and more stable sleep. There was a consistent decline in sleep disturbances.
**SecondaryEndpoint(**Skin Nourishment Improvement): The results showed a significant and consistent improvement in five key aspects of Skin Health: Hydration, elasticity, firmness, texture, and radiance documented through Skin****Hydration Scoring System (SHSS). The Skin Hydration Scoring System shows a remarkable increase from 1.97 in Visit 1 to 8.63 in Visit 4, reflecting deep and sustained hydration. Elasticity, firmness, and texture have all seen substantial enhancements. Satisfaction levels surged, reaching 9.82, highlighting the product’s effectiveness in delivering visible results.
No AEs or SAEs were reported in the study confirming the safety profile of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects between 18 and 65 years.
- •2.Clinically diagnosed cases of Sleeplessness, defined as difficulty falling asleep, maintaining sleep, or early morning awakening, occurring at least 3 nights per week for the past 3 months, as per standard diagnostic criteria (e.g., DSM-5).
- •3.Baseline Pittsburgh Sleep Quality Index (PSQI) score of ≥5, indicating poor sleep quality.
- •4.Willingness to sign informed consent and comply with all study procedures, including scheduled visits and use of the investigational product.
- •Generally healthy individuals or individuals with controlled medical conditions that do not interfere with the study objectives, as determined by the investigator.
排除标准
- •1.Pregnant or lactating women.
- •2.Participants with acute or uncontrolled medical conditions, such as severe respiratory conditions (e.g., COPD, asthma), cardiovascular diseases, or acute illnesses that could interfere with sleep or study participation.
- •3.Known history of significant psychiatric or neurological disorders, including major depression, bipolar disorder, schizophrenia, or sleep disorders associated with other mental or neurological conditions.
- •History of alcohol or drug abuse within the past 6 months, or current use of sedative-hypnotic medications.
- •History of systemic glucocorticoid consumption within the past 6 months.
- •6.Known allergies or hypersensitivity to any of the ingredients in the investigational product.
- •Participation in another clinical trial within the past 3 months.
- •Participants who, in the opinion of the investigator, are unlikely to adhere to the study treatment or protocol requirements.
结局指标
主要结局
The primary endpoint of the study is the improvement in sleep quality from baseline to Day 45, measured using the Pittsburgh Sleep Quality Index (PSQI). A reduction in the PSQI score, which evaluates sleep latency, duration, efficiency, and disturbances, will indicate improved sleep quality.
时间窗: Day 1, Day 15, Day 30, and Day 45
次要结局
- 1.Skin Hydration and Health: The hydrating effects of Dream Body Cream will be evaluated using the Skin Hydration Scoring System (SHSS) over 45 days, with assessments at Baseline (Day 0), Days 15, 30, and 45. An improvement in SHSS scores is expected, indicating enhanced skin hydration and health.
研究者
Dr Sambashiva
Sri Lakshmi Super Speciality Hospital