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

NCT07754383 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2025XLA162-2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Obesity

Keywords

Insomnia; Obesity; Medicine, Chinese Traditional; Autonomic Nervous System; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (8)

• Body Weight

  Body weight will be measured in kilograms using a calibrated digital scale.

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

• Body Fat Percentage Assessed by Bioelectrical Impedance Analysis (BIA)

  Body fat percentage will be measured using the InBody 770 Body Composition Analyzer.

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

• Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)

  Skeletal muscle mass (in kilograms) will be measured using the InBody 770 Body Composition Analyzer.

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

• Waist-to-Hip Ratio (WHR)

  WHR is calculated by dividing waist circumference (in centimeters) by hip circumference (in centimeters).

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

• Pittsburgh Sleep Quality Index (PSQI) Score

  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).

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

• Insomnia Severity Index (ISI) Score

  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).

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

• Total Sleep Time (TST) Assessed by Polysomnography (PSG)

  TST is defined as the total amount of sleep time scored during the total overnight recording time, measured in minutes.

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

• Sleep Efficiency (SE) Assessed by Polysomnography (PSG)

  Sleep efficiency is calculated as the ratio of Total Sleep Time to Time in Bed, expressed as a percentage (%).

  Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)

Secondary Outcomes (9)

• 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)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Qingxin Jiaotai Decoction + Personalized Lifestyle Intervention Plan

Drug: Qingxin Jiaotai Decoction

Control Group

PLACEBO COMPARATOR

Placebo control + personalized lifestyle intervention program

Drug: Placebo

Interventions

Placebo DRUG

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.

Also known as: Placebo Combined with Personalized Lifestyle Intervention Program

Control Group

Qingxin Jiaotai Decoction DRUG

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.

Also known as: Qingxin Jiaotai Decoction Combined with Personalized Lifestyle Intervention Plan

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fohow Pharmaceutical Group: lead
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator

Study Sites (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Haidian, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Obesity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jin Zhang

CONTACT

+86 10 62835180; xyyyzwb@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)