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

Early Phase 1Not Yet RecruitingNCT07754383

Fohow Pharmaceutical Group72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Insomnia Obesity

Interventions

Qingxin Jiaotai DecoctionDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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