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Sleep DisorderNCT05908903

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

A study testing Drinks with active ingredients such as poria and GABA in people with Sleep Disorder, run by Botanee Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 25 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sleep Disorder
What is being tested?
Drinks with active ingredients such as poria and GABA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteChina
Study dates
9 Jul 2022to 7 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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;

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai China-norm Quality Technical Service Co ，Ltd

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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.

Read the 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
Being tested
Drinks with active ingredients such as poria and GABA
Keywords
Sleep quality and skin conditions
Medical subject headings
Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drinks with active ingredients such as poria and GABACombination 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.

Study groups in NCT05908903
Study groupRoleWhat they receive
Experimental GroupExperimentalTake drinks with active ingredients such as poria and GABA. Drink half an hour before bedtime, 10ml/bag/day, daily.
Receives: Combination Product: Drinks with active ingredients such as poria and GABA
Control product groupPlacebo comparatorTake a control drink that does not contain GABA and poria. Drink half an hour before bedtime, 10ml/bag/day, daily.
Receives: Combination Product: Drinks with active ingredients such as poria and GABA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week0（Baseline）、Week2、Week4

  2. 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.

    Measured: Week0（Baseline）、Week2、Week4

  3. Sleep Quality Assessment after 2-week application

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

    Measured: Week2

  4. Sleep Quality Assessment after 4-week application

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

    Measured: Week4

Secondary outcomes (13)

  1. 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.

    Measured: Week0（Baseline）、Week2、Week4

  2. 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.

    Measured: Week0（Baseline）、Week2、Week4

  3. 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.

    Measured: Week0（Baseline）、Week2、Week4

  4. 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.

    Measured: Week0（Baseline）、Week2、Week4

  5. 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.

    Measured: Week0（Baseline）、Week2、Week4

  6. 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.

    Measured: Week0（Baseline）、Week2、Week4

  7. 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.

    Measured: Week0（Baseline）、Week2、Week4

  8. 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.

    Measured: Week0（Baseline）、Week2、Week4

  9. 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.

    Measured: Week0（Baseline）、Week2、Week4

  10. 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.

    Measured: Week0（Baseline）、Week2、Week4

  11. Skin condition Assessment after 2-week application

    Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire

    Measured: Week2

  12. Skin condition Assessment after 4-week application

    Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire

    Measured: Week4

  13. 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.

    Measured: Week0（Baseline）、Week2、Week4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start9 Jul 2022
  3. Primary completion7 Aug 2022
  4. Study completion7 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05908903
Sponsor's protocol ID
Botanee
Status last verified
Jun 2023
First submitted
29 May 2023
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data is used to develop new products, no decision has been made on when to disclose

Questions about this trial

What is this clinical trial studying?

A study testing Drinks with active ingredients such as poria and GABA in people with Sleep Disorder, run by Botanee Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Pittsburgh Sleep Quality Index (time frame: Week0（Baseline）、Week2、Week4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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