A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sleep Disorder
- Sponsor
- Botanee Group Co., Ltd.
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Changes in the Pittsburgh Sleep Quality Index
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Changes in the Pittsburgh Sleep Quality Index
Time Frame: 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
Time Frame: 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
Time Frame: Week4
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Sleep Quality Assessment after 2-week application
Time Frame: Week2
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Secondary Outcomes
- 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)