Qing-Xin-Jiao-Tai Decoction for Adults With Both Insomnia and Obesity
Tests Qing-Xin-Jiao-Tai Decoction against placebo in adults with insomnia and obesity.
Plain-language title generated from the registry record
Registry title: Qing-Xin-Jiao-Tai Decoction for Insomnia Comorbid With Obesity Presenting With Heart-Kidney Non-interaction Syndrome
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07754383, who can take part
Where in China
- Xiyuan Hospital, China Academy of Chinese Medical SciencesBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fohow Pharmaceutical Group
- Trial code
- NCT07754383
- Record updated
- 10 August 2026
- Original description
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.Read full original descriptionShow less
Intelligent Diagnosis and Effective Prescription Verification of Sleep Disorders Complicated With Obesity Based on Disease-syndrome Combination
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.
Inclusion: 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: 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; 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; 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; Women planning to become pregnant, pregnant, or breastfeeding; 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.