Dataset Information

The microcirculatory characteristics of the heart and lung meridians: Study protocol clinical trial (SPIRIT Compliant).

ABSTRACT: INTRODUCTION:The aim of the present study is to compare the microcirculatory difference of different meridians by using laser doppler flowmetry and investigate the specificity for the meridian-visceral association and site-to-site association between 2 specific meridians. METHODS AND ANALYSIS:The Lung and Heart meridians are chosen as 2 specific studied meridians. 120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group. Laser doppler flowmetry will be used to assess the blood perfusion of the Heart and Lung meridians. The specificity for the meridian-visceral association will be investigated by comparing the microcirculatory difference between the Heart and Lung meridians in the healthy control group and chronic stable angina pectoris group. Besides, participants in the healthy intervention group will receive 2 sessions of moxibustion in the Heart meridian and Lung meridian, respectively, to explore the specificity for the site-to-site association on the body surface. Primary outcomes will be blood flow curve and blood perfusion units of relevant sites along the Heart and Lung meridians. Statistical analysis will be conducted by third party statisticians. ETHICS AND DISSEMINATION:Ethics approval (approval No: ZSLL-KY-2019-001A-01) has been obtained from the Ethics Committee of the Third Affiliated Hospital of Zhejiang Chinese Medical University. The study findings will be disseminated through presentation at peer-reviewed medical journals. TRIAL REGISTRATION:ClinicalTrials.gov NCT04244812.

SUBMITTER: Hu H

PROVIDER: S-EPMC7220657 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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The microcirculatory characteristics of the heart and lung meridians: Study protocol clinical trial (SPIRIT Compliant).

Hu Hantong H Jiang Yongliang Y Li Xiaoyu X Lou Jiali J Zhang Yajun Y He Xiaofen X Fang Junfan J Wu Yuanyuan Y Shao Xiaomei X Fang Jianqiao J

Medicine 20200401 14

<h4>Introduction</h4>The aim of the present study is to compare the microcirculatory difference of different meridians by using laser doppler flowmetry and investigate the specificity for the meridian-visceral association and site-to-site association between 2 specific meridians.<h4>Methods and analysis</h4>The Lung and Heart meridians are chosen as 2 specific studied meridians. 120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and ...[more]

PMID: 32243379

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Project description:ObjectiveBy comparing the differences in microcirculatory responses of the heart and lung meridians induced by moxibustion on these two meridians, respectively, this study aimed to investigate the specificity for site-to-site association on body surface between different meridians.MethodsEighty healthy adults were enrolled and divided into the lung meridian intervention group and heart meridian intervention group in a ratio of 1 : 1. Three-channel laser Doppler flowmetry was used to monitor microcirculatory responses for the heart and lung meridians. Primary outcome was change of blood perfusion units (PU) of three measurement sites along the two meridians.ResultsIn the lung meridian intervention group, following moxibustion performed at LU5 of the lung meridian, PU in the distal site of the lung meridian increased significantly. By contrast, the PU of HT3 in the heart meridian, which was nearest to the moxibustion site, did not change significantly. PU in the distal site of the heart meridian declined. Meanwhile, significant difference in PU change was detected between the distal site of the lung meridian and the other two control sites of the heart meridians during moxibustion and postmoxibustion. Alternatively, similar to the results of the lung meridian intervention group, the specificity of microcirculatory response between the heart and lung meridians was observed in the heart meridian intervention group.ConclusionsFor the heart and lung meridians, the effect of moxibustion-induced microcirculatory response may be more related to meridian routes than the specific distance between two sites located at different meridians, thereby supporting possible specificity for site-to-site association on the body surface between these two meridians. Nevertheless, given that only two meridians and limited measurement sites were compared, all current findings are not sufficiently robust. Further research should be conducted to investigate more meridians and measurement sites.

Project description:BackgroundFunctional dyspepsia (FD) is a highly prevalent functional gastrointestinal disorder which brings a significant impact on patients' quality of life. Although there are many available treatments to alleviate dyspepsia symptoms, most of them are far from satisfactory. Traditional Chinese medicine (TCM) has shown good potential in the treatment of FD, especially in terms of improving symptoms and adverse effects of Western medicine. Qizhi Weitong granule (QZWTG), a TCM preparation, has been utilized in treating FD for a long time and has achieved good clinical results. However, the existing evidence of its efficacy and mechanism of action is insufficient. Hence, the purpose of this study is to evaluate the efficacy and safety of QZWTG in the treatment of FD.MethodsThis study is a multicenter, randomized, double-blinded, double-placebo, positive drug parallel controlled clinical study. The experiment will be carried out in 8 hospitals at the same time, and a total of 384 cases of participants will be randomly assigned to the experimental group and the control group (n = 192). The experimental group will be given QZWTG and Mosapride citrate tablet placebo, and the control group will be given QZWTG placebo and Mosapride citrate tablet. After 4 weeks of intervention and 2 weeks of follow-up, the efficacy and safety of QZWTG in patients with FD will be observed. The primary outcomes are the change in the main symptom score. The secondary outcomes include TCM syndrome evaluation, the change of the Hamilton anxiety scale and the Hamilton depression scale, and advanced events. This study will explore the biological mechanism of QZWTG in the treatment of FD through the results of blood and urine metabolomics.DiscussionThis trial will provide first-hand evidence on whether QZWTG is noninferior to Mosapride citrate tablet. There will be a new option for the treatment of FD if noninferiority is set up. In addition, the efficacy and safety of QZWTG in the treatment of FD will be evaluated, and the mechanism of QZWTG in the treatment of FD will be explored through the metabolomics of blood and urine. On the other hand, as far as we know, this study may be the largest trial of efficacy and safety of QZWTG in the treatment of FD, which has important application value.

Project description:BackgroundBreast cancer is the most prevalent cancer in females and disease recurrence remains a significant problem. To prevent recurrence, tamoxifen is prescribed for at least 5 years. However, among patients who receive tamoxifen, individual responses are highly variable. These responses are affected by the type, frequency, and severity of endocrine symptoms, as well as adherence rates. Polymorphisms in genes involved in the metabolism of tamoxifen (ie, CYP3A4, CYP2D6) may influence responses to tamoxifen. In this study, the inter-relationships among endocrine symptoms, drug adherence, and genetic polymorphisms in Chinese breast cancer patients receiving tamoxifen therapy will be examined. We hypothesize that patients with more severe endocrine symptoms will be less likely to adhere to tamoxifen treatment. In addition, we hypothesize that a relationship will exist between the severity of tamoxifen-induced symptoms and allelic variations in tamoxifen metabolism-related genes. Although many association studies have determined that select genotypes influence the efficacy of tamoxifen, very few studies have investigated for associations between tamoxifen-induced endocrine symptoms and these polymorphisms.ObjectivesThe aim of this study was to characterize genetic polymorphisms in tamoxifen metabolism-associated genes in Chinese women with breast cancer and to explore the inter-relationships between genetic polymorphisms, endocrine symptoms, and adherence to tamoxifen.MethodWe will conduct a prospective cohort study that follows 200 Chinese women over 18 months and assess treatment-related symptoms and genetic variations. Endocrine symptoms and drug adherence will be determined through interview-administered standardized questionnaires. Polymorphisms in drug metabolism genes will be determined using real-time polymerase chain reaction based genotyping method. Data will be analyzed to determine associations between allelic variations, endocrine symptoms, and adherence.DiscussionThe proposed study will evaluate for polymorphisms in gene(s) that are associated with tamoxifen-related endocrine symptoms and adherence with tamoxifen. We will explore the relationships between genotypes, endocrine symptoms, and drug adherence in Chinese breast cancer patients. Findings from this study may assist clinicians to identify patients at higher risk for a worse symptom experience and lower adherence rates and enable them to initiate appropriate interventions. In the long term, the findings from this study may be used to develop and test tailored symptom management interventions for these patients.

Project description:IntroductionInterventions aimed at addressing subthreshold depression (StD) are important to prevent the onset of major depressive disorder. Our video playback application (SPSRS) is designed to reduce depressive symptoms by presenting positive words in videos, shedding new light on the treatment of StD. However, no randomized controlled trial (RCT) has utilized this video playback application for the treatment of individuals with StD. Therefore, a pilot RCT was designed to determine the feasibility of a full-scale trial. We herein present a study protocol for investigating the utility of a video playback application intervention for individuals with StD.MethodsThis 5-week, single-blind, 2-arm, parallel-group, pilot RCT will determine the effectiveness of the video playback application by comparing individuals who had and had not been exposed to the same. A total of 32 individuals with StD will be randomly assigned to the experimental or control group at a 1:1 ratio. The experimental group will receive a 10-minute intervention containing the video playback application per day, whereas the control group will receive no intervention. The primary outcome will include changes in the Center for Epidemiologic Studies Depression Scale score after the 5-week intervention, while secondary outcomes will include changes in the Kessler Screening Scale for psychological distress and the generalized anxiety disorder 7-item scale score after the 5-week intervention. Statistical analysis using linear mixed models with the restricted maximum likelihood estimation method will then be performed.DiscussionThis pilot RCT will have been the first to explore the utility of SPSRS application interventions that display positive words in videos for individuals with StD. The results of this pilot trial are expected to help in the design and implementation of a full-scale RCT that investigates the effects of SPSRS applications among individuals with StD.Trial registrationClinicalTrials.gov Identifier: NCT04136041.

Project description:IntroductionWhile the role of early mobilization in the immediate postinfarction period has been well demonstrated, little is known in present about the link between early mobilization and reduction of systemic inflammation. At the same time, the impact of early mobilization on regression of left ventricular remodeling has not been elucidated so far.Material and methodsHere we present the study protocol of the REHAB trial, a clinical descriptive, prospective study, conducted in a single-center, with the purpose to analyze the impact of early mobilization in reducing left ventricular remodeling, the complication rates and mortality in patients who had suffered a recent acute myocardial infarction (AMI). At the same time, the study aims to demonstrate the contribution of early mobilization to reduction of systemic inflammation, thus reducing the inflammation-mediated ventricular remodeling. 100 patients with AMI in the last 12 hours, and successful revascularization of the culprit artery within the first 12 hours after the onset of symptoms in ST-segment elevation acute myocardial infarction or within first 48 hours in non ST-segment elevation AMI will be enrolled in the study. Based on the moment of mobilization after AMI patients will be distributed in 2 groups: group 1 - patients with early mobilization (<2 days after the onset of symptoms) and; group 2 - subjects with delayed mobilization after AMI (>2 days after the onset of symptoms). Study outcomes will consist in the impact of early mobilization after AMI on the ventricular remodeling in the post-infarction period, as assessed by cardiac magnetic resonance imaging, the rate of in-hospital mortality, the rate of repeated revascularization or MACE and the effect of early mobilization on systemic inflammation in the immediate postinfarction phase.ConclusionIn conclusion, REHAB will be the first trial that will elucidate the impact of early mobilization in the first period after AMI, as a first step of a complex cardiac rehabilitation program, to reduce systemic inflammation and prevent deleterious ventricular remodeling in patients who suffered a recent AMI.

Dataset Information

The microcirculatory characteristics of the heart and lung meridians: Study protocol clinical trial (SPIRIT Compliant).

Publications

The microcirculatory characteristics of the heart and lung meridians: Study protocol clinical trial (SPIRIT Compliant).

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