Intelligent Diagnosis and Effective Prescription Verification of Sleep Disorders Complicated With Obesity Based on Disease-syndrome Combination
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of Qing-Xin-Jiao-Tai Decoction (QXJTD), a Traditional Chinese Medicine formula, in treating adults (aged 18-65) suffering from both insomnia and obesity. Specifically, the study targets patients diagnosed with Heart-Kidney Non-interaction syndrome. In this study, 72 eligible participants will be randomly assigned to receive either QXJTD granules or a matching placebo twice daily for 8 weeks. Both groups will concurrently receive a personalized lifestyle intervention program that includes structured dietary and exercise guidance. The primary purpose of this research is to determine if QXJTD combined with lifestyle modifications can significantly improve sleep quality and promote weight loss compared to the placebo. The primary endpoints evaluated will be objective sleep parameters measured via overnight polysomnography, the percentage of body weight lost, and subjective sleep improvements assessed by the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI). By evaluating these outcomes, the researchers hope to provide a safe and effective integrative treatment strategy for patients struggling with this complex comorbidity.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who meet both diagnostic criteria for sleep disorders and obesity, and have a Pittsburgh Sleep Quality Index (PSQI) score exceeding 7
- •Meet the TCM syndrome differentiation criteria for either the heart-kidney disharmony syndrome or the liver-fire disturbing the heart syndrome
- •Aged 18-65, male or female
- •Those who can actively cooperate with oral Chinese medicine treatment
- •Voluntarily accept this study and sign the informed consent form
排除标准
- •Patients with severe cardiovascular and cerebrovascular diseases, hematological system diseases, severe liver and kidney dysfunction, tumors, and other severe organic diseases
- •Individuals with a history of allergy to the study drug or with an allergic constitution
- •Women planning to become pregnant, pregnant, or breastfeeding
- •Currently taking or having taken sedative traditional Chinese patent medicines and simple preparations within 4 weeks prior to enrollment, or having used semaglutide and other GLP-1 receptor agonists or weight-reducing preparations with long-term weight-loss effects within 12 weeks prior to enrollment
- •Those with severe cognitive dysfunction or unable to take care of themselves and therefore unable to cooperate with the clinical trial protocol
- •Patients with severe anxiety, depression [Self-rating Anxiety Scale (SAS) score ≥70, Self-rating Depression Scale (SDS) score ≥73], mania, schizophrenia, and suicidal tendencies.
- •Individuals who are severely allergic to PSG electrode patches, or who cannot cooperate with polysomnography (PSG) and heart rate variability (HRV) testing due to work/lifestyle habits
研究组 & 干预措施
Experimental Group
Qingxin Jiaotai Decoction + Personalized Lifestyle Intervention Plan
干预措施: Qingxin Jiaotai Decoction (Drug)
Control Group
Placebo control + personalized lifestyle intervention program
干预措施: Placebo (Drug)
结局指标
主要结局
Body Weight
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Body weight will be measured in kilograms using a calibrated digital scale.
Body Fat Percentage Assessed by Bioelectrical Impedance Analysis (BIA)
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Body fat percentage will be measured using the InBody 770 Body Composition Analyzer.
Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Skeletal muscle mass (in kilograms) will be measured using the InBody 770 Body Composition Analyzer.
Waist-to-Hip Ratio (WHR)
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
WHR is calculated by dividing waist circumference (in centimeters) by hip circumference (in centimeters).
Pittsburgh Sleep Quality Index (PSQI) Score
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
The PSQI is a self-report questionnaire that assesses sleep quality. The total global score ranges from 0 to 21. Higher scores indicate worse sleep quality (a worse outcome).
Insomnia Severity Index (ISI) Score
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The total score ranges from 0 to 28. Higher scores indicate greater insomnia severity (a worse outcome).
Total Sleep Time (TST) Assessed by Polysomnography (PSG)
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
TST is defined as the total amount of sleep time scored during the total overnight recording time, measured in minutes.
Sleep Efficiency (SE) Assessed by Polysomnography (PSG)
时间窗: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Sleep efficiency is calculated as the ratio of Total Sleep Time to Time in Bed, expressed as a percentage (%).
次要结局
- Number of Participants With Clinically Significant Abnormalities in Blood Routine Test(Baseline (Week 0), Endpoint (Week 8))
- Number of Participants With Clinically Significant Abnormalities in Liver and Kidney Function Tests(Baseline (Week 0), Endpoint (Week 8))
- Number of Participants With Clinically Significant Abnormalities in Urinalysis(Baseline (Week 0), Endpoint (Week 8))
- Number of Participants With Clinically Significant Abnormalities on Electrocardiogram (ECG)(Baseline (Week 0), Endpoint (Week 8))
- Sleep and Quality of Life Assessment Scale(Baseline (Week 0), Endpoint (Week 8))
- The frequency, dosage, and date of taking sedative, anti-anxiety, and anti-depression western medications(Baseline (Week 0), Endpoint (Week 8))
- Serum Interleukin-6 (IL-6) Concentration(Baseline (Week 0), Endpoint (Week 8))
- Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration(Baseline (Week 0), Endpoint (Week 8))
- Serum High-sensitivity C-reactive Protein (hs-CRP) Concentration(Baseline (Week 0), Endpoint (Week 8))