Qing-Xin-Jiao-Tai Decoction for Insomnia Comorbid With Obesity Presenting With Heart-Kidney Non-interaction Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Qingxin Jiaotai Decoction: Participants in the experimental group will receive Qing-Xin-Jiao-Tai Decoction (QXJTD) granules, custom-prepared by the Preparation Room of Xiyuan Hospital. It is administered orally twice daily, 1 sachet per dose dissolved in 250 mL of warm water, taken 30 minutes before lunch and dinner for 12 weeks. QXJTD comprises 11 Traditional Chinese Medicine herbs, including Fructus Tritici Levis, Herba Lophatheri, Herba Menthae, Semen Nelumbinis, Bulbus Lilii, Concha Ostreae, Colla Corii Asini, Fructus Amomi, Poria cum Pini Radice, Cortex Cinnamomi, and Semen Ziziphi Spinosae. Concurrently, participants will adhere to a standardized, personalized lifestyle intervention (PLSI) program managed via a dedicated WeChat mini-program, which incorporates tailored dietary calorie/macro calculations (carbohydrates 50%-65%, proteins 10%-15%, fats 20%-30%), weekly structured aerobic/resistance exercise prescriptions (at least 150 minutes/week), and behavioral monitoring by a multidisciplinary team.

Placebo: Participants in the control group will receive a matched placebo decoction in granule form, manufactured to be identical to QXJTD in appearance, color, odor, and taste. To ensure blinding efficacy and baseline contrast, the active ingredient content of the prepared placebo is strictly controlled to less than 10% of the active ingredients in QXJTD. The administration method is identical to the experimental group: orally twice daily, 1 sachet per dose dissolved in 250 mL of warm water 30 minutes before lunch and dinner for 12 weeks. Participants will simultaneously receive the exact same personalized lifestyle intervention (PLSI) plan (encompassing dietary management, exercise prescriptions, and WeChat mini-program digital monitoring) as the experimental group.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Body Weight — 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) — 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) — 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) — 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 — 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 — 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) — 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) — 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 (%).

Trial sites (1)

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