Back to resultsA Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
Primary Purpose
Sleep Disorder
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drinks with active ingredients such as poria and GABA
Sponsored by
About this trial
This is an interventional other trial for Sleep Disorder focused on measuring Sleep quality and skin conditions
Eligibility Criteria
Inclusion Criteria: 25-55 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; Exclusion Criteria: 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.
Sites / Locations
- Shanghai China-norm Quality Technical Service Co ，Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control product group
Arm Description
Take drinks with active ingredients such as poria and GABA. Drink half an hour before bedtime, 10ml/bag/day, daily.
Take a control drink that does not contain GABA and poria. Drink half an hour before bedtime, 10ml/bag/day, daily.
Outcomes
Primary Outcome Measures
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.
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.
Sleep Quality Assessment after 2-week application
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Sleep Quality Assessment after 4-week application
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Secondary Outcome Measures
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.
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.
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.
Changes in the skin elasticity
Obtain change from Baseline skin elasticity at 2 weeks by cutometer. Obtain change from Baseline skin elasticity at 4 weeks by cutometer.
Changes in the individual type angle
Obtain change from Baseline Individual type angle at 2 weeks by Colorimeter. Obtain change from Baseline Individual type angle at 4 weeks by Colorimeter.
Changes in the proportion of crow's feet area
Calculate the proportion of crow's feet area by Visia CR images. Obtain change from Baseline proportion of crow's feet area at 2 weeks. Obtain change from Baseline proportion of crow's feet area at 4 weeks.
Changes in the proportion of fine lines under the eye
Calculate the proportion of fine lines under the eye by Visia CR images. Obtain change from Baseline proportion of fine lines under the eye at 2 weeks. Obtain change from Baseline proportion of fine lines under the eye at 4 weeks.
Changes in the degree of wrinkle severity
Obtain change from Baseline degree of wrinkle severity at 2 weeks by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.
Obtain change from Baseline degree of wrinkle severity at 4 weeks by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.
Changes in the grade of skin dryness
Obtain change from Baseline grade of skin dryness at 2 weeks by Dermatologist evaluation according to 5-point dryness scale.
Obtain change from Baseline grade of skin dryness at 4 weeks by Dermatologist evaluation according to 5-point dryness scale.
Changes in the CIE RGB of skin tone
Dermatologist use PANTONE SkinTone (Pantone color card) skin color guide to evaluate skin tone grade of subjects. Find the CIE RGB corresponding to the skin tone grade in Pantone ColorManager software and convert it into a color value using the formula for data analysis: CIE RGB = R+G*256+B*256*256.
Calculate the change from Baseline CIE RGB of skin tone at 2 weeks. Calculate the change from Baseline CIE RGB of skin tone at 4 weeks.
Skin condition Assessment after 2-week application
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire
Skin condition Assessment after 4-week application
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire
Changes in the satisfaction with the quality of life
Obtain change from Baseline satisfaction with the quality of life at 2 weeks accessed by WHOQOL-100 questionnaire.
Obtain change from Baseline satisfaction with the quality of life at 4 weeks accessed by WHOQOL-100 questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05908903
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2022 (Actual)
Primary Completion Date
August 7, 2022 (Actual)
Study Completion Date
August 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Botanee Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
Sleep quality and skin conditions
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Take drinks with active ingredients such as poria and GABA. Drink half an hour before bedtime, 10ml/bag/day, daily.
Arm Title
Control product group
Arm Type
Placebo Comparator
Arm Description
Take a control drink that does not contain GABA and poria. Drink half an hour before bedtime, 10ml/bag/day, daily.
Intervention Type
Combination Product
Intervention Name(s)
Drinks with active ingredients such as poria and GABA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the Pittsburgh Sleep Quality Index
Description
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
Title
Changes in the sleep duration
Description
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
Title
Sleep Quality Assessment after 2-week application
Description
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Time Frame
Week2
Title
Sleep Quality Assessment after 4-week application
Description
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Time Frame
Week4
Secondary Outcome Measure Information:
Title
Changes in the skin hydration
Description
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
Title
Changes in the skin glossiness
Description
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
Title
Changes in the skin firmness
Description
Obtain change from Baseline skin firmness at 2 weeks by cutometer. Obtain change from Baseline skin firmness at 4 weeks by cutometer.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Changes in the skin elasticity
Description
Obtain change from Baseline skin elasticity at 2 weeks by cutometer. Obtain change from Baseline skin elasticity at 4 weeks by cutometer.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Changes in the individual type angle
Description
Obtain change from Baseline Individual type angle at 2 weeks by Colorimeter. Obtain change from Baseline Individual type angle at 4 weeks by Colorimeter.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Changes in the proportion of crow's feet area
Description
Calculate the proportion of crow's feet area by Visia CR images. Obtain change from Baseline proportion of crow's feet area at 2 weeks. Obtain change from Baseline proportion of crow's feet area at 4 weeks.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Changes in the proportion of fine lines under the eye
Description
Calculate the proportion of fine lines under the eye by Visia CR images. Obtain change from Baseline proportion of fine lines under the eye at 2 weeks. Obtain change from Baseline proportion of fine lines under the eye at 4 weeks.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Changes in the degree of wrinkle severity
Description
Obtain change from Baseline degree of wrinkle severity at 2 weeks by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.
Obtain change from Baseline degree of wrinkle severity at 4 weeks by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Changes in the grade of skin dryness
Description
Obtain change from Baseline grade of skin dryness at 2 weeks by Dermatologist evaluation according to 5-point dryness scale.
Obtain change from Baseline grade of skin dryness at 4 weeks by Dermatologist evaluation according to 5-point dryness scale.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Changes in the CIE RGB of skin tone
Description
Dermatologist use PANTONE SkinTone (Pantone color card) skin color guide to evaluate skin tone grade of subjects. Find the CIE RGB corresponding to the skin tone grade in Pantone ColorManager software and convert it into a color value using the formula for data analysis: CIE RGB = R+G*256+B*256*256.
Calculate the change from Baseline CIE RGB of skin tone at 2 weeks. Calculate the change from Baseline CIE RGB of skin tone at 4 weeks.
Time Frame
Week0（Baseline）、Week2、Week4
Title
Skin condition Assessment after 2-week application
Description
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire
Time Frame
Week2
Title
Skin condition Assessment after 4-week application
Description
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire
Time Frame
Week4
Title
Changes in the satisfaction with the quality of life
Description
Obtain change from Baseline satisfaction with the quality of life at 2 weeks accessed by WHOQOL-100 questionnaire.
Obtain change from Baseline satisfaction with the quality of life at 4 weeks accessed by WHOQOL-100 questionnaire.
Time Frame
Week0（Baseline）、Week2、Week4
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Identification by Chinese ID card
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
25-55 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;
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song Weiming, Master
Organizational Affiliation
Yan Shu Medical Beauty Chain Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai China-norm Quality Technical Service Co ，Ltd
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data is used to develop new products, no decision has been made on when to disclose
Learn more about this trial
A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
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