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

NCT05908903 | Completed

• 1 other identifier: Botanee
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Keywords

Sleep quality and skin conditions

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Week0（Baseline）、Week2、Week4

• Sleep Quality Assessment after 2-week application

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

  Week2

• Sleep Quality Assessment after 4-week application

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

  Week4

Secondary Outcomes (13)

• Changes in the skin hydration

  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 skin elasticity

  Week0（Baseline）、Week2、Week4

• Changes in the individual type angle

  Week0（Baseline）、Week2、Week4

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Combination Product: Drinks with active ingredients such as poria and GABA

Control product group

PLACEBO COMPARATOR

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

Combination Product: Drinks with active ingredients such as poria and GABA

Interventions

Drinks with active ingredients such as poria and GABA 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; Experimental Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Gender Eligibility Details: Identification by Chinese ID card
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;
• Have any other health problems or chronic diseases;
• 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);
• 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.

Sponsors & Collaborators

• Botanee Group Co., Ltd.: lead

Study Sites (1)

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Skin Diseases

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Song Weiming, Master

  Yan Shu Medical Beauty Chain Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: July 9, 2022
• Primary Completion: August 7, 2022
• Study Completion: August 7, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)