Insomnia, Obesity
Conditions
Keywords
Insomnia, Obesity, Medicine, Chinese Traditional, Autonomic Nervous System, Randomized Controlled Trial
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.
Interventions
DRUGQingxin 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.
DRUGPlacebo
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.
Sponsors
Fohow Pharmaceutical Group
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Blood Routine Test | Baseline (Week 0), Endpoint (Week 8) | Safety will be assessed by counting the number of participants who experience treatment-emergent, clinically significant abnormal values in blood routine tests. |
| Number of Participants With Clinically Significant Abnormalities in Liver and Kidney Function Tests | Baseline (Week 0), Endpoint (Week 8) | Safety will be assessed by counting the number of participants who experience treatment-emergent, clinically significant abnormal values in liver and kidney function tests. |
| Number of Participants With Clinically Significant Abnormalities in Urinalysis | Baseline (Week 0), Endpoint (Week 8) | Safety will be assessed by counting the number of participants who experience treatment-emergent, clinically significant abnormal values in routine urinalysis. |
| Number of Participants With Clinically Significant Abnormalities on Electrocardiogram (ECG) | Baseline (Week 0), Endpoint (Week 8) | Safety will be assessed by counting the number of participants who present with treatment-emergent, clinically significant abnormal findings on a standard 12-lead ECG. |
| 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) | IL-6 concentration will be measured from fasting venous blood samples to evaluate systemic inflammation. |
| Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration | Baseline (Week 0), Endpoint (Week 8) | TNF-α concentration will be measured from fasting venous blood samples to evaluate systemic inflammation. |
| Serum High-sensitivity C-reactive Protein (hs-CRP) Concentration | Baseline (Week 0), Endpoint (Week 8) | hs-CRP concentration will be measured from fasting venous blood samples to evaluate systemic inflammation. |
Countries
China
Contacts
CONTACTJin Zhang
Outcome results
None listed