Mild to Moderate Sleep DisorderNCT07207252
Research on Sleep and Emotion Testing of Tea Theanine Casein Hydrolysate Pressed Candy
A study testing Tea Theanine Casein Hydrolysate Pressed Candy and Pressed Candy in people with Mild to Moderate Sleep Disorder and Pressure, run by ChinaNorm at 1 site in China.
Trial summary
The study evaluates the improvement of sleep, emotion, and skin by standardizing the use of the blend (Tea Theanine Casein Hydrolysate Pressed Candy, whose active ingredients include Tea Theanine, Casein Hydrolysate, and Saffron Extract). This is a randomized, double-blind trial for Chinese people aged 20-55. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Mild to Moderate Sleep Disorder, Pressure
- What is being tested?
- Tea Theanine Casein Hydrolysate Pressed Candy and Pressed Candy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2024to 5 Dec 2024
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese participants aged 20-55,
- Mild to moderate sleep disorders (Pittsburgh Sleep Quality Index 5-21),
- At least 2/3 of the population is under pressure (PSS-10 ≥ 14),
- No plans to leave Shanghai in the past three months,
- Have basic Chinese reading comprehension and expression abilities and can independently complete the questionnaire survey,
- Voluntarily participate in the test and sign an informed consent form,
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- Willing to comply with all evaluation requirements, use the product according to the research protocol, and complete testing and follow-up. During the trial period, do not change the original dietary or skincare habits or use other similar foods, health products, or drugs.
- Chinese participants aged 23-55,
- Right-handedness (not acquired through training),
- Pressure group (PSS-10 ≥ 14),
- No plans to leave Shanghai in the past three months,
- Have basic Chinese reading comprehension and expression abilities, and can independently complete the questionnaire survey,
- Voluntarily participate in the test and sign an informed consent form,
- Willing to comply with all evaluation requirements, use the product according to the research protocol, and complete testing.
Who cannot join
- Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
- History of tea allergy,
- History of dairy product allergies,
- Due to occupational reasons requiring night work or regular changes in working hours,
- Regularly staying up late within one month before the test (not due to objective reasons or negative emotions, the frequency of staying up late is greater than once per week, such as playing games, watching TV shows, etc.),
- Intending to become pregnant, or currently pregnant or breastfeeding,
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- Currently treating diseases other than sleep disorders,
- Using facial and eye skincare products with whitening and spot-removing effects,
- Has a history of alcohol abuse,
- There were unhealed skin lesions on the face currently,
- Have undergone surgical procedures, plastic surgery, or organ transplantation in the past year,
- Any other health problems or chronic illnesses other than sleep and emotions,
- Other iatrogenic reasons considered by the expert or professional may influence the evaluation outcome.
- Sub study 2：
- Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
- History of tea allergy,
- History of dairy product allergies,
- Unable to effectively induce negative emotions during on-site testing (POMS stress scale and panic scale scores after emotional induction are not higher than baseline),
- Before testing, any obvious physiological discomfort, including but not limited to fever, hunger, dysmenorrhea, cough, lack of sleep, etc.,
- Frequent insomnia and irregular sleep patterns within a month,
- Anemia,
- Abnormal blood sugar and blood pressure,
- Neurological disorders,
- Self-reported neurological or emotional disorders such as depression, anxiety, bipolar disorder, and obsessive-compulsive disorder diagnosed by clinical psychiatrists,
- Alcohol, cigarette addiction, or drug dependence,
- During drug treatment, ①The individual has systematically taken hypnotic drugs (barbiturates, etc.) or other central nervous system drugs within one year. ②The individual has systematically used anti-anxiety drugs (Benzodiazepines such as diazepam, chlorpromazine, and clonazepam), antiepileptic drugs (such as phenobarbital or clonazepam), antipsychotic, antidepressant, and anti-dementia drugs within one year.
- Intending to become pregnant, or currently pregnant or breastfeeding,
- Other iatrogenic reasons considered by the expert or professional may influence the outcome of the evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Sleep & Stress Test
The study evaluates the improvement of sleep, emotion, and skin by standardizing the use of the blend (Tea Theanine Casein Hydrolysate Pressed Candy, whose active ingredients include Tea Theanine, Casein Hydrolysate, and Saffron Extract).
This is a randomized, double-blind trial for Chinese people aged 20-55. The change of sleep, emotion, skin, and other related indicators of 90 participants after taking Tea Theanine Casein Hydrolysate Pressed Candy, whose active ingredients include tea theanine, casein hydrolysate, and saffron extract, was evaluated through a 28 days product placement test (sub study 1), and the emotional change of 70 participants after taking Tea Theanine Casein Hydrolysate Pressed Candy was evaluated through an EEG test (sub study 2).
Participants who meet the inclusion criteria were randomly assigned to use the experimental product or the placebo control. In sub study 1, 90 participants completed a 7-day baseline period, a 28-day testing period (T1d, T7d, and T28d). In sub study 2, 71 participants completed a single on-site test.
- Conditions
- Mild to Moderate Sleep Disorder, Pressure
- Being tested
- Tea Theanine Casein Hydrolysate Pressed Candy, Pressed Candy
- Keywords
- Tea Theanine, Casein Hydrolysate, EEG, Emotion, Sleep Disorder
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea Theanine Casein Hydrolysate Pressed CandyDietary supplement
Take 4 candies once a day. It is recommended to consume it one hour before bedtime.
Pressed CandyDietary supplement
Take 4 candies once a day.
| Study group | Role | What they receive |
|---|---|---|
| Tea Theanine Casein Hydrolysate Pressed Candy | Experimental | Take 4 Tea Theanine Casein Hydrolysate Pressed Candies once a day. Receives: Dietary Supplement: Tea Theanine Casein Hydrolysate Pressed Candy |
| Pressed Candy | Placebo comparator | Take 4 Pressed Candies once a day. Receives: Dietary Supplement: Pressed Candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores of Pittsburgh Sleep Quality Index, PSQI (28 Days Product Placement Test)
The total score range is 0-21 points. The higher the score, the worse the sleep quality.
Measured: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
Change in scores of Restorative Sleep Questionnaire Weekly Version (RSQ-W) and Daily Version (RSQ-D) (28 Days Product Placement Test)
The total score is calculated based on the average score of the questionnaire items, and then the average score is converted to a 0-100 scale using the formula: (average score - 1) * 25. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep.
Measured: T0 (baseline before consumption, RSQ-W was used), T1d (after consumption for one day, RSQ-D was used), T1wk (after consumption for one week, RSQ-W was used), T4wk (after consumption for four weeks, RSQ-W was used)
Change in the Fall asleep time, Nighttime sleep duration, Shallow sleep duration, Shallow sleep ratio and Sleep latency (28 Days Product Placement Test)
These indicators were collected by Huawei Smart Band HA580.
Measured: Continuous collection during placement (7-day baseline+28-day product placement test)
Change in the Wakefulness frequency, Sleep quality, Sleepiness in the morning, Refreshment in the morning, mood in the morning, Sleep latency (28 Days Product Placement Test)
The sleep status of participants was tracked through sleep diaries.
Measured: Continuous collection during placement (7-day baseline+28-day product placement test)
Change in the scores of Perceived Stress Scale, PSS-10 (28 Days Product Placement Test)
The total score is calculated based on the cumulative score of the questionnaire items, ranging from 0 to 40 points, with higher scores indicating greater perceived stress.
Measured: T0 (baseline before consumption), T1wk (after consumption for one week), T4wk (after consumption for four weeks)
Change in the scores of The State-Trait Anxiety Inventory, the S-Form, S-AI (28 Days Product Placement Test)
The total score is calculated based on the cumulative score of the questionnaire items, ranging from 20 to 80 points, with higher scores indicating greater anxiety.
Measured: T0 (baseline before consumption), T1d (after consumption for one day), T1wk (after consumption for one week), T4wk (after consumption for four weeks)
Change in the scores of Profile of Mood States, POMS (28 Days Product Placement Test)
The total score is calculated based on the cumulative score of the questionnaire items, ranging from 56 to 216 points. Higher scores indicate stronger negative emotions, reflecting a depressed mood and feelings of irritability.
Measured: T0 (baseline before consumption), T1d (after consumption for one day), T1wk (after consumption for one week), T4wk (after consumption for four weeks)
Change in the Skin tone evenness, Glossiness, ITA°, L, a, b, Dark circles (Under orbital pigmentation area) ITA°, L (28 Days Product Placement Test)
All-face skin images under different light sources were captured by VISIA-CR (CANFIELD, America).
Measured: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
Change in the Protrusion volume in Eye bag area (28 Days Product Placement Test)
Protrusion volume in Eye bag area was measured by Primos (CANFIELD, America).
Measured: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
Change in the Skin smoothness, softness, glossiness, hydration, tone evenness, Overall appearance (28 Days Product Placement Test)
Dermatologists score the facial skin condition of participants using validated assessment scales (VAS). Scores for each dimension range from 0 to 9, and higher scores reflect a better skin condition.
Measured: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
The improvement of dark circles and eye bags (28 Days Product Placement Test)
Dermatologists evaluate the improvement of dark circles and eye bags in participants through baseline and follow-up visit VISIA photos, using an integrated visualization system (IVS) with improved investigator visual score. Each score range from 0 to 3, and higher scores represent a higher level of improvement.
Measured: T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
Change in the scores of Profile of Mood States, POMS (EEG Test)
The sore of tension subscale ranges from 0 to 24 and confusion subscale ranges from 0 to 20, with higher scores indicating greater tension/confusion. The total score is calculated based on the cumulative score of the questionnaire items, ranging from 56 to 216 points. Higher scores indicate stronger negative emotions, reflecting a depressed mood and feelings of irritability.
Measured: Before emotional induction (only tension and confusion scales), immediately after emotional induction, and 60 minutes after using the product
Change in the Brain wave α power (EEG Test)
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Measured: During emotion inducting, 60 minutes after consuming the product
Change in the Brain wave β power (EEG Test)
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Measured: During emotion inducting, 60 minutes after consuming the product
Change in the Brain wave θ power (EEG Test)
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Measured: During emotion inducting, 60 minutes after consuming the product
Change in the Brain wave θ/β power ratio (EEG Test)
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Measured: During emotion inducting, 60 minutes after consuming the product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start28 Oct 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Sleep DisorderStudies of the same condition, open and under way.
- More trials run by ChinaNormThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nu Skin Enterprises
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207252
- Sponsor's protocol ID
- W24002001
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep & Stress Test
- ClinicalTrials.gov ID
- NCT07207252
- Acronym / sponsor ID
- W24002001
- Conditions
- Mild to Moderate Sleep Disorder, Pressure
- Keywords
- Tea Theanine, Casein Hydrolysate, EEG, Emotion, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Collaborators
- Nu Skin Enterprises
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the improvement of sleep, emotion, and skin by standardizing the use of the blend (Tea Theanine Casein Hydrolysate Pressed Candy, whose active ingredients include Tea Theanine, Casein Hydrolysate, and Saffron Extract).
This is a randomized, double-blind trial for Chinese people aged 20-55. The change of sleep, emotion, skin, and other related indicators of 90 participants after taking Tea Theanine Casein Hydrolysate Pressed Candy, whose active ingredients include tea theanine, casein hydrolysate, and saffron extract, was evaluated through a 28 days product placement test (sub study 1), and the emotional change of 70 participants after taking Tea Theanine Casein Hydrolysate Pressed Candy was evaluated through an EEG test (sub study 2).
Participants who meet the inclusion criteria were randomly assigned to use the experimental product or the placebo control. In sub study 1, 90 participants completed a 7-day baseline period, a 28-day testing period (T1d, T7d, and T28d). In sub study 2, 71 participants completed a single on-site test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tea Theanine Casein Hydrolysate Pressed Candy | Experimental | Dietary Supplement: Tea Theanine Casein Hydrolysate Pressed CandyTake 4 Tea Theanine Casein Hydrolysate Pressed Candies once a day. |
| Pressed Candy | Placebo comparator | Dietary Supplement: Pressed CandyTake 4 Pressed Candies once a day. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Chinese participants aged 20-55,
- Mild to moderate sleep disorders (Pittsburgh Sleep Quality Index 5-21),
- At least 2/3 of the population is under pressure (PSS-10 ≥ 14),
- No plans to leave Shanghai in the past three months,
- Have basic Chinese reading comprehension and expression abilities and can independently complete the questionnaire survey,
Key exclusion criteria (28 listed)
- Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
- History of tea allergy,
- History of dairy product allergies,
- Due to occupational reasons requiring night work or regular changes in working hours,
- Regularly staying up late within one month before the test (not due to objective reasons or negative emotions, the frequency of staying up late is greater than once per week, such as playing games, watching TV shows, etc.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tea Theanine Casein Hydrolysate Pressed CandyTake 4 candies once a day. It is recommended to consume it one hour before bedtime. | Dietary supplement | Tea Theanine Casein Hydrolysate Pressed Candy |
| Pressed CandyTake 4 candies once a day. | Dietary supplement | Pressed Candy |
Primary outcome
Change in scores of Pittsburgh Sleep Quality Index, PSQI (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
The total score range is 0-21 points. The higher the score, the worse the sleep quality.
Change in scores of Restorative Sleep Questionnaire Weekly Version (RSQ-W) and Daily Version (RSQ-D) (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption, RSQ-W was used), T1d (after consumption for one day, RSQ-D was used), T1wk (after consumption for one week, RSQ-W was used), T4wk (after consumption for four weeks, RSQ-W was used)
The total score is calculated based on the average score of the questionnaire items, and then the average score is converted to a 0-100 scale using the formula: (average score - 1) * 25. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep.
Change in the Fall asleep time, Nighttime sleep duration, Shallow sleep duration, Shallow sleep ratio and Sleep latency (28 Days Product Placement Test)
Time frame: Continuous collection during placement (7-day baseline+28-day product placement test)
These indicators were collected by Huawei Smart Band HA580.
Change in the Wakefulness frequency, Sleep quality, Sleepiness in the morning, Refreshment in the morning, mood in the morning, Sleep latency (28 Days Product Placement Test)
Time frame: Continuous collection during placement (7-day baseline+28-day product placement test)
The sleep status of participants was tracked through sleep diaries.
Change in the scores of Perceived Stress Scale, PSS-10 (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption), T1wk (after consumption for one week), T4wk (after consumption for four weeks)
The total score is calculated based on the cumulative score of the questionnaire items, ranging from 0 to 40 points, with higher scores indicating greater perceived stress.
Change in the scores of The State-Trait Anxiety Inventory, the S-Form, S-AI (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption), T1d (after consumption for one day), T1wk (after consumption for one week), T4wk (after consumption for four weeks)
The total score is calculated based on the cumulative score of the questionnaire items, ranging from 20 to 80 points, with higher scores indicating greater anxiety.
Change in the scores of Profile of Mood States, POMS (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption), T1d (after consumption for one day), T1wk (after consumption for one week), T4wk (after consumption for four weeks)
The total score is calculated based on the cumulative score of the questionnaire items, ranging from 56 to 216 points. Higher scores indicate stronger negative emotions, reflecting a depressed mood and feelings of irritability.
Change in the Skin tone evenness, Glossiness, ITA°, L, a, b, Dark circles (Under orbital pigmentation area) ITA°, L (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
All-face skin images under different light sources were captured by VISIA-CR (CANFIELD, America).
Change in the Protrusion volume in Eye bag area (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
Protrusion volume in Eye bag area was measured by Primos (CANFIELD, America).
Change in the Skin smoothness, softness, glossiness, hydration, tone evenness, Overall appearance (28 Days Product Placement Test)
Time frame: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
Dermatologists score the facial skin condition of participants using validated assessment scales (VAS). Scores for each dimension range from 0 to 9, and higher scores reflect a better skin condition.
The improvement of dark circles and eye bags (28 Days Product Placement Test)
Time frame: T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)
Dermatologists evaluate the improvement of dark circles and eye bags in participants through baseline and follow-up visit VISIA photos, using an integrated visualization system (IVS) with improved investigator visual score. Each score range from 0 to 3, and higher scores represent a higher level of improvement.
Change in the scores of Profile of Mood States, POMS (EEG Test)
Time frame: Before emotional induction (only tension and confusion scales), immediately after emotional induction, and 60 minutes after using the product
The sore of tension subscale ranges from 0 to 24 and confusion subscale ranges from 0 to 20, with higher scores indicating greater tension/confusion. The total score is calculated based on the cumulative score of the questionnaire items, ranging from 56 to 216 points. Higher scores indicate stronger negative emotions, reflecting a depressed mood and feelings of irritability.
Change in the Brain wave α power (EEG Test)
Time frame: During emotion inducting, 60 minutes after consuming the product
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Change in the Brain wave β power (EEG Test)
Time frame: During emotion inducting, 60 minutes after consuming the product
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Change in the Brain wave θ power (EEG Test)
Time frame: During emotion inducting, 60 minutes after consuming the product
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Change in the Brain wave θ/β power ratio (EEG Test)
Time frame: During emotion inducting, 60 minutes after consuming the product
EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea Theanine Casein Hydrolysate Pressed Candy and Pressed Candy in people with Mild to Moderate Sleep Disorder and Pressure, run by ChinaNorm 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 14 inclusion and 28 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 3 Oct 2025. 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?
Change in scores of Pittsburgh Sleep Quality Index, PSQI (28 Days Product Placement Test) (time frame: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.