Clinical trial NCT05908903: A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
Official title: A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Keywords: Sleep quality and skin conditions
Lead sponsor: Botanee Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. 25-55 years old, Chinese female;
2. PSQI index ≥ 7 (presence of sleep disorders);
3. The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;
4. The BMI of the subjects was between 18\~24kg/m2;
5. 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);
6. Corneometer base measurement of facial skin moisture in 15\~45 (Corneometer Unit, C.U.) Between;
7. Have basic Chinese reading ability;
8. can use smartphones;
9. Be in good health and free of any other chronic diseases other than skin problems and sleep disorders or diseases being treated;
10. Voluntarily participate in the test and sign the informed consent form; 11） Willingness to comply with all evaluation requirements;

Exclusion Criteria:

1. Products with anti-wrinkle, firming, repairing and nourishing effects are not included in the skin care products used;
2. Intend to become pregnant, or are pregnant or breastfeeding;
3. Have a history of alcoholism;
4. Have a history of allergies;
5. Participated in any clinical trial evaluation within 1 month;
6. Those who have applied any anti-inflammatory drugs to the test site within the past two months;
7. Those who have suffered from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
8. patients with insulin-dependent diabetes;
9. Patients with asthma or other chronic respiratory diseases who are being treated;
10. Have taken/injected anti-allergic drugs in the past 1 month;
11. Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;
12. Have any other health problems or chronic diseases;
13. 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);
14. 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.

Primary outcomes:
measure: Changes in the Pittsburgh Sleep Quality Index
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the sleep duration
timeFrame: Week0（Baseline）、Week2、Week4
measure: Sleep Quality Assessment after 2-week application
timeFrame: Week2
measure: Sleep Quality Assessment after 4-week application
timeFrame: Week4
Secondary outcomes:
measure: Changes in the skin hydration
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the skin glossiness
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the skin firmness
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the skin elasticity
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the individual type angle
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the proportion of crow's feet area
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the proportion of fine lines under the eye
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the degree of wrinkle severity
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the grade of skin dryness
timeFrame: Week0（Baseline）、Week2、Week4
measure: Changes in the CIE RGB of skin tone
timeFrame: Week0（Baseline）、Week2、Week4
measure: Skin condition Assessment after 2-week application
timeFrame: Week2
measure: Skin condition Assessment after 4-week application
timeFrame: Week4
measure: Changes in the satisfaction with the quality of life
timeFrame: Week0（Baseline）、Week2、Week4
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co ，Ltd
state: Shanghai
Study officials:
affiliation: Yan Shu Medical Beauty Chain Group
name: Song Weiming, Master
role: PRINCIPAL_INVESTIGATOR
References: