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

NCT ID: NCT05908903

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-09
• Study Completion Date: 2022-08-07

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.

Conditions

Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

Take drinks with active ingredients such as poria and GABA. Drink half an hour before bedtime, 10ml/bag/day, daily.

Group Type: EXPERIMENTAL

Drinks with active ingredients such as poria and GABA

Intervention Type: COMBINATION_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.

Control product group

Take a control drink that does not contain GABA and poria. Drink half an hour before bedtime, 10ml/bag/day, daily.

Group Type: PLACEBO_COMPARATOR

Drinks with active ingredients such as poria and GABA

Intervention Type: COMBINATION_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.

Interventions

Drinks with active ingredients such as poria and GABA

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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Botanee Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Song Weiming, Master

Role: PRINCIPAL_INVESTIGATOR

Yan Shu Medical Beauty Chain Group

Locations

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

Botanee

Identifier Type: -

Identifier Source: org_study_id