Clinical trial

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

Name
Botanee
Description
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.
Trial arms
Trial start
2022-07-09
Estimated PCD
2022-08-07
Trial end
2022-08-07
Status
Completed
Treatment
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.
Arms:
Control product group, Experimental Group
Size
70
Primary endpoint
Changes in the Pittsburgh Sleep Quality Index
Week0(Baseline)、Week2、Week4
Changes in the sleep duration
Week0(Baseline)、Week2、Week4
Sleep Quality Assessment after 2-week application
Week2
Sleep Quality Assessment after 4-week application
Week4
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}
Updated at
2023-06-18

1 organization

1 product

1 indication

Indication
Sleep Disorder
Organization
Botanee Group