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Sleeping EfficacyNCT07677709

A Real-World Exploratory Study on the Sleep-Improving Efficacy of Dong'e Brand Ejiao Yuanjiang

A study testing Dong'e Brand Ejiao Yuanjiang in people with Sleeping Efficacy and Sleep Quality, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study employs a real-world design to evaluate the sleep-improving efficacy of Dong'e Brand Ejiao Yuanjiang. A total of 66 participants aged 25-55 will be enrolled and assessed after 60 days of continuous use. Read more about this study

Who is it for?
Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Sleeping Efficacy, Sleep Quality
What is being tested?
Dong'e Brand Ejiao Yuanjiang
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteChina
Study dates
6 Mar 2026to 10 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males and non-pregnant, non-lactating females aged 25-55 years (inclusive; subjects exceeding 55 years of age during the trial will not be excluded);
  • Body weight ≥50 kg for males and ≥45 kg for females, with a Body Mass Index (BMI) ranging from 18.5 to 27.9 kg/m² (inclusive of boundary values);
  • Subjects in good general health, with no history of cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric, or metabolic diseases, or any other conditions that, in the investigator's judgment, may affect the study;
  • Signed the informed consent form (ICF) prior to the trial, demonstrating a full understanding of the study content, procedures, and potential adverse reactions, and capable of communicating effectively with the investigators;
  • A score of ≥23 on the Self-Rating Scale of Sleep (SRSS) or ≥10 on the Pittsburgh Sleep Quality Index (PSQI);
  • Self-reported sleep problems, such as difficulty falling asleep or frequent awakenings during sleep;
  • Self-reported post-sleep fatigue or lethargy (e.g., feeling physically tired or mentally sluggish upon waking).

Who cannot join

  • Significant abnormalities in laboratory tests (blood routine, liver and kidney function) that, in the investigator's opinion, render the subject unsuitable for participation in the trial;
  • History of esophageal reflux, gastric bleeding, or peptic ulcer disease within 180 days prior to the trial; experiencing heartburn more than once a week; or having undergone any surgical procedure (e.g., cholecystectomy) that may affect the absorption of the study product;
  • History of specific allergies (such as asthma, urticaria, eczema, etc.), allergic constitution (e.g., allergy to two or more drugs, foods, or pollens), or known hypersensitivity to any component of the study product;
  • History of long-term and heavy alcohol consumption, or alcohol consumption habits that, in the investigator's judgment, may affect trial evaluation or subject safety;
  • Pregnant, lactating, or planning to become pregnant;
  • Consumption of sleep aids or neurological regulatory foods and drugs within 90 days prior to the trial;
Show all 11Show fewer
  • Presence of chronic diseases such as hypertension, hyperlipidemia, or hyperglycemia;
  • History of congenital porphyria metabolism disorders (e.g., acute intermittent porphyria);
  • Smoking more than 3 cigarettes per day; or alcohol consumption of ≥3 standard drinks/day for males and ≥2 standard drinks/day for females;
  • A previous clinical diagnosis of severe sleep disorders or mental debility based on the International Classification of Sleep Disorders, Third Edition (ICSD-3), the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and the Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults; or a Self-Rating Scale of Sleep (SRSS) score ≥40;
  • Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

This study employs a real-world design to evaluate the sleep-improving efficacy of Dong'e Brand Ejiao Yuanjiang. A total of 66 participants aged 25-55 will be enrolled and assessed after 60 days of continuous use.

Being tested
Dong'e Brand Ejiao Yuanjiang, Placebo
Keywords
Sleep Quality, sleeping efficacy
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

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

  • Dong'e Brand Ejiao YuanjiangDietary supplement

    Dong'e Brand Ejiao Yuanjiang

  • PlaceboOther

    Placebo

Study groups in NCT07677709
Study groupRoleWhat they receive
treatment groupExperimentalDong'e Brand Ejiao Yuanjiang
Receives: Dietary Supplement: Dong'e Brand Ejiao Yuanjiang
control groupPlacebo comparatorplacebo
Receives: Other: Placebo

What is being measured

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

  1. Score of Self-Rating Scale of Sleep

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  2. Pittsburgh Sleep Quality Index

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  3. Number of awakenings

    Number of awakenings is recorded from the data of Smart Band

    Measured: record everyday from the one day after enrollment to the 60th day

  4. Percentage of light sleep

    Percentage of light sleep is recorded from the data of Smart Band

    Measured: record everyday from the one day after enrollment to the 60th day

  5. Total Sleep Time

    Total Sleep Time is recorded from the data of Smart Band

    Measured: record everyday from the one day after enrollment to the 60th day

  6. Percentage of deep sleep

    Percentage of deep sleep is recorded from the data of Smart Band

    Measured: record everyday from the one day after enrollment to the 60th day

  7. Percentage of REM sleep

    Percentage of REM sleep is recorded from the data of Smart Band

    Measured: record everyday from the one day after enrollment to the 60th day

  8. Deep sleep continuity

    Deep sleep continuity is recorded from the data of Smart Band

    Measured: record everyday from the one day after enrollment to the 60th day

Secondary outcomes (7)

  1. Insomnia Severity Index（ISI）

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  2. Sleep Disorders Rating Scale（SDRS）

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  3. Fatigue Scale-14

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  4. Serum γ-aminobutyric acid

    Serum γ-aminobutyric acid

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  5. Melatonin

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  6. Cortisol

    Measured: At baseline (screening/enrollment), and at 30 and 60 days after enrollment

  7. Score of product usage experiences

    a questionnaire about product experiences, max score is 50, min score is 0

    Measured: record weekly over the past 7 days

Timeline

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

  1. First posted1 Jul 2026
  2. Study start6 Mar 2026
  3. Primary completion10 May 2026
  4. Study completion10 Nov 2026 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07677709
Sponsor's protocol ID
SAHoWMU-CR2026-03-111
Status last verified
Jun 2026
First submitted
6 May 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li S, Li Y, Xue C, Zhang Y, Tong T, Ouyang Z, Liu D, Cai J, Sun H. Progress in Research on the Mechanism of GABA in Improving Sleep. Foods. 2025 Nov 11;14(22):3856. doi: 10.3390/foods14223856.

    PubMed 41300013

  • Khalid S, Bashir S, Mehboob R, Anwar T, Ali M, Hashim M, Waseem H, Basharat S. Effects of magnesium and potassium supplementation on insomnia and sleep hormones in patients with diabetes mellitus. Front Endocrinol (Lausanne). 2024 Oct 29;15:1370733. doi: 10.3389/fendo.2024.1370733. eCollection 2024.

    PubMed 39534260

  • 1)参考《保健食品功能检验与评价方法（2023）》

Questions about this trial

What is this clinical trial studying?

A study testing Dong'e Brand Ejiao Yuanjiang in people with Sleeping Efficacy and Sleep Quality, run by Second Affiliated Hospital of Wenzhou Medical University 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Score of Self-Rating Scale of Sleep (time frame: At baseline (screening/enrollment), and at 30 and 60 days after enrollment). The study lists 8 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 NCT07677709, which also lists 3 linked publications.

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 1 Jul 2026.

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