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

NCT07677709 | Active Not Recruiting

• 1 other identifier: SAHoWMU-CR2026-03-111
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleeping Efficacy; Sleep Quality

Keywords

Sleep Quality; sleeping efficacy

Outcome Measures

Primary Outcomes (8)

• Score of Self-Rating Scale of Sleep

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

• Pittsburgh Sleep Quality Index

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

• Number of awakenings

  Number of awakenings is recorded from the data of Smart Band

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

• Percentage of light sleep

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

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

• Total Sleep Time

  Total Sleep Time is recorded from the data of Smart Band

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

• Percentage of deep sleep

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

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

• Percentage of REM sleep

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

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

• Deep sleep continuity

  Deep sleep continuity is recorded from the data of Smart Band

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

Secondary Outcomes (7)

• Insomnia Severity Index（ISI）

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

• Sleep Disorders Rating Scale（SDRS）

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

• Fatigue Scale-14

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

• Serum γ-aminobutyric acid

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

• Melatonin

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

Other Outcomes (1)

• adverse event

  through study completion, an average of 2 months

Study Arms (2)

treatment group

EXPERIMENTAL

Dong'e Brand Ejiao Yuanjiang

Dietary Supplement: Dong'e Brand Ejiao Yuanjiang

control group

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Dong'e Brand Ejiao Yuanjiang DIETARY_SUPPLEMENT

Dong'e Brand Ejiao Yuanjiang

treatment group

Placebo OTHER

Placebo

control group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (3)

• 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.

  PMID: 41300013 BACKGROUND

• 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.

  PMID: 39534260 BACKGROUND

• 1)参考《保健食品功能检验与评价方法（2023）》

  BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ting Li

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: July 1, 2026
• Study Start: March 6, 2026
• Primary Completion: May 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)