Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

Abstract

Background Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 124 participants suffering from insomnia symptoms will be randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention. The primary outcome measures will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW. Trial registration Chinese Clinical Trial Registry, ChiCTR1800019239. Registered on 1st November 2018.

White Matter Alterations in Heart-kidney Imbalance Insomnia and Jiao-tai-wan Treatment: A Diffusion-tensor Imaging Study

“…The PSQI score was used to assess sleep quality and severity of sleep disorders in the past 7 days, while the PSG was mainly used to identify the sleep phases, such as REM, NREM, and wakefulness [29,42].…”

“…The inclusion criteria for HKIIPs were as follows: (a) Aged 18-to 60-years-old, right-handed, male and female, in junior high school or above; (b) According to the DSM-V, insomnia was de ned as having di culty falling asleep, staying asleep or having refreshing sleep, occurring 3 or more times per week, for at least 3 months [28]; (c) A PSQI score of greater than or equal to 7 according to the criteria for insomnia described in CCMD-3 [29]; (d) A Disharmony of Heart and Kidney Scoring System score is greater than 9 [29]; (e)Free of any psychoactive medication or hypnotic or cognitive behavioral therapy for insomnia for at least 2 weeks before the study. The brief ow diagram of the study process is shown in Fig.…”

White matter alterations in heart-kidney imbalance insomnia and Jiao-Tai-Wan treatment: A diffusion-tensor imaging study

“…The PSQI score of HKIIPs decreased significantly after treatment with JTW, reflecting the effectiveness of JTW in treating insomnia. The PSQI score was used to assess sleep quality and severity of sleep disorders in the past one month, while the PSG was mainly used to identify the sleep phases, such as REM, NREM, and wakefulness (Chen et al 2018 ; Zeng et al 2020 ). The PSG results showed no significant difference between the JTW and placebo groups after treatment, which could be due to the little effect of JTW on the sleep structure, or short-term treatment that has no effect on the structure of sleep.…”

“…The inclusion criteria for HKIIPs were as follows: (a) Aged 18- to 60- years-old, right-handed, male and female, in junior high school or above; (b) According to the DSM-V, insomnia was defined as having difficulty falling asleep, staying asleep or having refreshing sleep, occurring 3 or more times per week, for at least 3 months (Seow et al 2018 ); (c) A PSQI score of greater than or equal to 7 according to the criteria for insomnia described in CCMD-3 (Zeng et al 2020 ); (d) A Disharmony of Heart and Kidney Scoring System score is greater than 9 according to the “Guide Principles for Clinical Research of New Drugs of TCM” (Zeng et al 2020 ); (e) Free of any psychoactive medication or hypnotic or cognitive behavioral therapy for insomnia for at least 2 weeks before the study.…”

Traditional East Asian Herbal Medicine for Post-Stroke Insomnia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…The use of standardized HM, in particular, is emphasized to establish an effective HM use strategy for PSI treatment and confirm its expected effectiveness and safety. This review provides clinical information of some candidates for standardized herbal formulas, such as Chaihu-Longgu-muli decoction [66], Ningxin Anshen formula [41], Suanzaoren decoction [85], Jiaotai decoction [86], and insomnia granules. Third, future clinical trials should evaluate the changes in insomnia following the use of objective sleep measurements, such as actigraphy or polysomnography.…”