NCT05908903

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Botanee Group Co., Ltd. · Industry
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2022-07-09
• Primary completion: 2022-08-07
• Completion: 2022-08-07
• First posted: 2023-06-18
• Last updated: 2023-06-18

Locations

1 site across 1 country: China