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

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.

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.