A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in the Pittsburgh Sleep Quality Index
研究概览
简要总结
The main objective of the study is to observe changes in the subjects' sleep quality, skin condition and life status after 4 weeks of using a sleep aid drink (AOXMED Poria γ-aminobutyric acid drink).
This is a single-center, randomized, double-blind, controlled, 4-week (28-day) clinical study conducted in Chinese healthy women aged 25-55 years old who were offered a sleep aid drink.
详细描述
The study population is 70 healthy Chinese women aged 25-55 years with a PSQI ≥ 7 (presence of sleep disorder) who report current problems with dryness, roughness, dullness and lack of elasticity on their face. The subjects will be randomly divided into an experimental group and a control product group of 35 subjects each, and the distribution of age and total hours of sleep will be more or less equal in both groups.
Subjects will be formally enrolled after on-site assessment and will undergo follow-up site visits and test product administration. During the test cycle, subjects in the experimental group will take a drink with the active ingredients of Poria, Poria and GABA, and subjects in the control product group will take a control drink without Poria, Date Palm and GABA ingredients for 4 weeks. To avoid the influence of different skincare products on the results, all subjects will be asked to use the basic skincare products with only moisturizing ingredients provided by the sponsor during the test period. The efficacy of the test products will be verified by comparing the changes in sleep quality, skin condition and life status of the subjects before and after taking the test products for 2 and 4 weeks, and by comparing the differences in sleep quality, skin condition and life status between the test and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •25-55 years old, Chinese female;
- •PSQI index ≥ 7 (presence of sleep disorders);
- •The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;
- •The BMI of the subjects was between 18~24kg/m2;
- •After the doctor's clinical evaluation, there are mild facial skin roughness (1 point and above) and mild to moderate overall facial wrinkles (3~6 points);
- •Corneometer base measurement of facial skin moisture in 15~45 (Corneometer Unit, C.U.) Between;
- •Have basic Chinese reading ability;
- •can use smartphones;
- •Be in good health and free of any other chronic diseases other than skin problems and sleep disorders or diseases being treated;
- •Voluntarily participate in the test and sign the informed consent form; 11） Willingness to comply with all evaluation requirements;
排除标准
- •Products with anti-wrinkle, firming, repairing and nourishing effects are not included in the skin care products used;
- •Intend to become pregnant, or are pregnant or breastfeeding;
- •Have a history of alcoholism;
- •Have a history of allergies;
- •Participated in any clinical trial evaluation within 1 month;
- •Those who have applied any anti-inflammatory drugs to the test site within the past two months;
- •Those who have suffered from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
- •patients with insulin-dependent diabetes;
- •Patients with asthma or other chronic respiratory diseases who are being treated;
- •Have taken/injected anti-allergic drugs in the past 1 month;
- •Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;
- •Have any other health problems or chronic diseases;
- •Applying retinoids, A hydroxy acids, salicylic acids, hydroquinone within the past 3 months, or prescription drugs (antibiotics, retinoids, A hydroxy acids and steroids) in use within the past 6 months, oral contraceptives (if you have been taking the same contraceptive pills for the past 6 months, you can continue to take them);
- •Experts or professionals believe that there are other iatrogenic reasons that will affect the evaluation results; 15) Those who have undergone surgery, plastic surgery or organ transplantation in the past year.
结局指标
主要结局
Changes in the Pittsburgh Sleep Quality Index
时间窗: Week0（Baseline）、Week2、Week4
Obtain change from Baseline PSQI index at 2 weeks by questionnaire. Obtain change from Baseline PSQI index at 4 weeks by questionnaire.
Changes in the sleep duration
时间窗: Week0（Baseline）、Week2、Week4
Obtain change from Baseline sleep duration at 2 weeks by sleep quality monitoring bracelet. Obtain change from Baseline sleep duration at 4 weeks by sleep quality monitoring bracelet.
Sleep Quality Assessment after 4-week application
时间窗: Week4
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Sleep Quality Assessment after 2-week application
时间窗: Week2
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
次要结局
- Skin condition Assessment after 2-week application(Week2)
- Changes in the skin elasticity(Week0（Baseline）、Week2、Week4)
- Changes in the grade of skin dryness(Week0（Baseline）、Week2、Week4)
- Changes in the satisfaction with the quality of life(Week0（Baseline）、Week2、Week4)
- Changes in the skin hydration(Week0（Baseline）、Week2、Week4)
- Changes in the individual type angle(Week0（Baseline）、Week2、Week4)
- Changes in the proportion of crow's feet area(Week0（Baseline）、Week2、Week4)
- Changes in the proportion of fine lines under the eye(Week0（Baseline）、Week2、Week4)
- Changes in the skin glossiness(Week0（Baseline）、Week2、Week4)
- Changes in the skin firmness(Week0（Baseline）、Week2、Week4)
- Changes in the degree of wrinkle severity(Week0（Baseline）、Week2、Week4)
- Skin condition Assessment after 4-week application(Week4)
- Changes in the CIE RGB of skin tone(Week0（Baseline）、Week2、Week4)