Shanghai China-norm Quality Technical Service Co ,Ltd
Shanghai, Shanghai Municipality, 200000, China
NCT Number: NCT05908903
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.
Looking for future studies?
Notify Me25 year–55 year
Female
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200000, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week0(Baseline)、Week2、Week4
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
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: Week2
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Time frame: Week4
Obtain data on agreement with sleep improvement by sleep quality self-assessment questionnaire
Time frame: Week0(Baseline)、Week2、Week4
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
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
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
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
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
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
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
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
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
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: Week2
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire
Time frame: Week4
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire
Time frame: Week0(Baseline)、Week2、Week4
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.
Botanee Group Co., Ltd.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04598672
Chronic Disease, Disease Attributes
Oslo, Norway
View Trial DetailsNCT05917379
Anxiety, Anxiety Disorders
Hefei, Anhui, China
View Trial DetailsNCT05041647
Behavior, Behavioral Symptoms
Hamilton, Ontario, Canada
View Trial DetailsNCT04299490
Agnosia, Apnea
Baltimore, Maryland, United States
View Trial Details