A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney.

Background: Jiaotaiwan (JTW) is a classical tranquillizing prescription in traditional Chinese medicine (TCM) for the treatment of insomnia symptoms caused by disharmony of the heart and kidney (ISDHK). This study aimed to evaluate the effectiveness and safety of JTW for treating ISDHK in a double-blind, randomized, placebo-controlled trial. Methods: From September 2018 to February 2020, 128 participants with ISDHK were included in this single-center clinical trial. All participants were equally and randomly divided into either the JTW group (2-g JTW granules, b.i.d. for 7 days) or placebo group (2-g placebo granules, b.i.d. for 7 days). Pittsburgh Sleep Quality Index (PSQI) scores were set as the primary outcome, and polysomnography (PSG), 1H-magnetic resonance spectroscopy (1H-MRS), blood tests, and Disharmony of Heart and Kidney Scoring System (DHKSS) and clinical global impression (CGI) scores were used as secondary outcomes. Laboratory tests were used to evaluate the safety of JTW. All data were collected at baseline and posttreatment. Results: A total of 106 participants completed this clinical trial. Symptom relief was more apparent in the JTW group than the placebo group (PSQI total score: 9.34 ± 3.578 vs. 10.98 ± 3.073, respectively; p = 0.006). However, no PSG changes were observed between the two groups (p > 0.05). Higher CGI and lower DHKSS scores were observed after JTW treatment. Serum melatonin was increased in patients with ISDHK after JTW treatment (JTW, 339.09 ± 256.894 vs. placebo, 219.59 ± 169.045; p = 0.004). There were significant posttreatment differences in metabolites in the left cerebellum between the two groups (myoinositol: JTW, 13.47 ± 2.094 vs. placebo, 12.48 ± 2.449; p = 0.021; choline: JTW, 3.96 ± 0.657 vs. placebo, 3.65 ± 0.562; p = 0.008). In terms of safety, JTW had no noticeable adverse effects relative to placebo. Conclusion: JTW was effective and well tolerated for the treatment of ISDHK. The development of large-scale trials with longer follow-up durations is recommended to provide further evidence. Clinical Trial Registration: clinicaltrials.gov, identifier ChiCTR1800019239.

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.

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.

[Effect of safflower injection on pulmonary hypertension in rat during chronic hypoxia and hypercapnia].

AIM: To study the effect of Safflower injection (a compound of Chinese Traditional medicine) on pulmonary hypertension in rat during chronic hypoxia and hypercapnia. METHODS: Sprague-Dawley rats were randomly divided into normal control group (A), hypoxic hypercapnic group (B), hypoxic hypercapnia + Safflower injection group (C). The concentration of TXB2 and 6-keto-PGF18 in plasma and in lung homogenate were detected by the radioimmunoassay. RESULTS: (1) mPAP, weight ratio of right ventricle (RV) to left ventricle plus septum (LV + S) were much higher in rats of hypoxic hypercapnic group than those of control group. Differences of mCAP among the three groups were not significant. (2) The concentration of TXB2 and the ratio of TXB2/6-keto-PGF1a were significantly higher in rats of B group than those of A and C group. (3) The results examined by light microscopy showed that WA/TA (vessel wall area/total area), SMC (the density of medial smooth muscle cell) and PAMT (the thickness of medial smooth cell layer) were significantly higher in rats of B group than those of A and C group. (4) The results examined by electron microscopy showed proliferation of medial smooth muscle cells and collagen fibers of pulmonary arterioles in rats of B group, and Safflower injection could reverse the changes mentioned above. CONCLUSION: Safflower injection may inhibit hypoxic hypercapnia pulmonary hypertension and pulmonary vessel remodeling by decreasing the ratio of TXB2/6-keto-PGF1a.