A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks

Botanee Group Co., Ltd.70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Sleep Disorder

Interventions

Drinks with active ingredients such as poria and GABACOMBINATION_PRODUCT

Take drinks half an hour before bedtime, 10ml/bag/day, daily. Subjects are uniformly using skin care products provided by the sponsor during the test.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Changes in the Pittsburgh Sleep Quality Index

Obtain change from Baseline PSQI index at 2 weeks by questionnaire. Obtain change from Baseline PSQI index at 4 weeks by questionnaire.

Time frame: Week0（Baseline）、Week2、Week4

Changes in the sleep duration

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.

Time frame: Week0（Baseline）、Week2、Week4

Sleep Quality Assessment after 2-week application

Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire

Time frame: Week2

Sleep Quality Assessment after 4-week application

Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire

Time frame: Week4

Secondary Outcomes

Changes in the skin hydration

Obtain change from Baseline skin hydration at 2 weeks by Corneometer. Obtain change from Baseline skin hydration at 4 weeks by Corneometer.

Time frame: Week0（Baseline）、Week2、Week4

Changes in the skin glossiness

Obtain change from Baseline skin glossiness at 2 weeks by Glossymeter. Obtain change from Baseline skin glossiness at 4 weeks by Glossymeter.

Time frame: Week0（Baseline）、Week2、Week4

Changes in the skin firmness

Obtain change from Baseline skin firmness at 2 weeks by cutometer. Obtain change from Baseline skin firmness at 4 weeks by cutometer.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.