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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Quality; Sleeping Efficacy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Dong'e Brand Ejiao Yuanjiang

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; placebo	Other: Placebo; Placebo
Experimental: treatment group; Dong'e Brand Ejiao Yuanjiang	Dietary supplement: Dong'e Brand Ejiao Yuanjiang; Dong'e Brand Ejiao Yuanjiang

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
Cortisol		At baseline (screening/enrollment), and at 30 and 60 days after enrollment
Score of product usage experiences	a questionnaire about product experiences, max score is 50, min score is 0	record weekly over the past 7 days

Other Outcome Measures

Outcome Measure	Time Frame
adverse event	through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Ting Li, Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

General 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.
• 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.
• 1)参考《保健食品功能检验与评价方法（2023）》

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Actual): May 10, 2026
• Study Completion (Estimated): November 10, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Quality; sleeping efficacy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: SAHoWMU-CR2026-03-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No