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

Second Affiliated Hospital of Wenzhou Medical University1 个研究点分布在 1 个国家目标入组 66 人开始时间: 2026年3月6日最近更新: 2026年7月1日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 66
试验地点: 1
主要终点: Score of Self-Rating Scale of Sleep

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 25 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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).

排除标准

•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.

结局指标

主要结局

Score of Self-Rating Scale of Sleep

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

Pittsburgh Sleep Quality Index

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

Number of awakenings