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Obesity / Qingxin Jiaotai Decoction / Insomnia · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered, not-yet-recruiting Phase 1 randomized controlled trial comparing Qing-Xin-Jiao-Tai Decoction (a Traditional Chinese Medicine formula) plus lifestyle intervention to placebo plus lifestyle intervention in 72 adults with comorbid insomnia and obesity. No results are posted in this registry record; the study is in the planning phase and will measure sleep quality, body composition, and weight over 8 weeks with 12-week follow-up.
Early Phase 1, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Insomnia, Obesity; age from 18 Years; to 65 Years. Intervention: Experimental Group. Compared with: Control Group — Placebo Comparator. n = 72. 1 site: China.
This is a registered, not-yet-recruiting Phase 1 randomized controlled trial comparing Qing-Xin-Jiao-Tai Decoction (a Traditional Chinese Medicine formula) plus lifestyle intervention to placebo plus lifestyle intervention in 72 adults with comorbid insomnia and obesity. No results are posted in this registry record; the study is in the planning phase and will measure sleep quality, body composition, and weight over 8 weeks with 12-week follow-up.
Primary outcomes include subjective measures (PSQI, ISI) and body composition endpoints; hard clinical outcomes (e.g., disease remission, hospitalization, mortality) are not stated.
This record presents a planned intervention with no outcome data. Clinicians should not infer efficacy. The study design (Phase 1, small sample, combined intervention with lifestyle counseling) is appropriate for initial signal-seeking but will not support clinical practice recommendations until results are published and independently replicated.
This is an early-phase (Phase 1) registered trial not yet recruiting with no results posted; it describes a planned study design and endpoints but carries no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This record presents a planned intervention with no outcome data. Clinicians should not infer efficacy. The study design (Phase 1, small sample, combined intervention with lifestyle counseling) is appropriate for initial signal-seeking but will not support clinical practice recommendations until results are published and independently replicated.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07754383). This is a study registration, not published results. Lead sponsor: Fohow Pharmaceutical Group. Recruitment status: NOT_YET_RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 72 participants (ESTIMATED). Conditions: Insomnia, Obesity. Interventions: DRUG: Qingxin Jiaotai Decoction; DRUG: Placebo. Primary outcome measures: Body Weight , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12); Body Fat Percentage Assessed by Bioelectrical Impedance Analysis (BIA) , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12); Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA) , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12); Waist-to-Hip Ratio (WHR) , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12); Pittsburgh Sleep Quality Index (PSQI) Score , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12); Insomnia Severity Index (ISI) Score , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12); Total Sleep Time (TST) Assessed by Polysomnography (PSG) , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12); Sleep Efficiency (SE) Assessed by Polysomnography (PSG) , Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12). Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.