A Study on the Microcirculatory Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Blood flow curve
研究概览
简要总结
Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes.Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study is designed to assess the microcirculatory characteristics of meridian phenomenon for the Heart and Lung meridians by using laser doppler. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology
详细描述
This study will include 40 patients diagnosed with chronic obstructive pulmonary disease (COPD) and 80 healthy volunteers. Laser doppler examination will be adopted to assess the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. Moreover, the site specificity for the meridian-visceral association and surface-surface association between the Heart and Lung meridians will be investigated.Primary outcomes will be blood flow curve and blood perfusion units(PU).Furthermore, this study will build standardized techniques and schemes for detecting the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians. The results of this study could also provide scientific foundation for traditional meridian theories.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the COPD group
- •Patients should meet the above diagnostic criteria, and the severity of COPD is in the stage of GOLD 2 or 3 based on pulmonary function testing;
- •COPD patients in the stable phase, who present with mild symptoms of cough, expectoration and short breath;
- •35 ≤ age ≤75 years, male or female;
- •Patients have clear consciousness and could communicate with others normally;
- •Patients could understand the full study protocol and have high adherence.Written informed consent is signed by themselves or their lineal kin.
- •Inclusion criteria for health volunteers
- •Healthy volunteers who could provide a recent (in the past 3 month) medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
- •age ≥20 years, male or female;
- •Participants have clear consciousness and could communicate with others normally;
- •Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin.
排除标准
- •Exclusion criteria for the COPD group
- •Patients who fail to meet the diagnostic criteria for COPD, or COPD patients in the phase of acute exacerbation;
- •Patients have the following complications, which includes pneumonia, bronchial asthma, bronchiectasis, active tuberculosis, pneumothorax, chest trauma, tumors of the lung or thorax, and other confirmed respiratory diseases;
- •Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris (CSAP);
- •Patients have serious concomitant conditions and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological, and nervous system;
- •Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;
- •Pregnant or lactating patients; Patients are participating in other trials.
- •Exclusion criteria of health volunteers
- •Participants have sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.
- •Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
- •Pregnant or lactating participants ;
- •Participants are participating in other trials.
结局指标
主要结局
Blood flow curve
时间窗: 5 minutes of baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion.
The blood flow curve could reflect the microcirculatory flux in the measuring sites.
Blood perfusion units
时间窗: 5 minutes of baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion.
Perfusion units (PU)=concentration of moving blood cells (CMBC)×velocity (V)
次要结局
未报告次要终点
研究者
Jianqiao Fang
President
Zhejiang Chinese Medical University