Research on Innovative Diagnosis and Treatment System of Syndrome Differentiation of Zang-fu Viscera and Effectiveness Evaluation Based on Inter-Arm Blood Pressure Measured Simultaneously
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Blood pressure measurement in both arms
研究概览
简要总结
By combining the measurement of blood pressure in both arms with the information of the four diagnoses of TCM, we try to form a diagnostic model of "five diagnoses combined with ginseng" based on TCM Zang-fu syndrome differentiation. It can further objectify and visualize the fuzzy four diagnostic indicators of TCM. In order to solve the problem of data differentiation of TCM four diagnoses, and optimize the five diagnoses of TCM conjunctive index, explore the establishment of TCM intelligent diagnosis and treatment and contact evaluation computer system
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case inclusion Criteria:
- •Patients were treated with epigastric pain and / or insomnia, which met the above diagnostic criteria for diseases, liver and spleen;
- •diagnostic criteria for diseases, liver and spleen;
- •Age 18-65 years old;
- •It can combine mild and moderate depression, anxiety Sign the informed consent form.
- •Healthy control inclusion criteria:
- •PSQI < 5 points;
- •No hypertension, diabetes, hyperlipidemia, coronary heart disease and other underlying diseases;
- •No depression, anxiety, malignant tumor, syphilis, HIV and other infectious diseases;
- •Over 18 years of age;
- •Volunteer to participate in this study, cooperate with the measurement of blood pressure in both arms, and sign the informed consent.
排除标准
- •Case exclusion criteria:
- •Patients with insomnia disorder caused by uneffectively controlled or serious diseases, such as malignant tumor, persistent pain, cardiovascular and cerebrovascular diseases, endocrine diseases, etc.;
- •patients with severe depression and mental illness;
- •Pregnant and lactation patients.
- •Healthy controls exclusion criteria:
- •sleep apnea syndrome or restless leg syndrome and other sleep disorders;
- •Pregnant and lactation;
- •Abnormal symptoms and abnormal tongue pulse occur in the body, such as facial acne, dysmenorrhea, thick and greasy tongue coating, loose stools, fat tongue, teeth marks and tongue.
结局指标
主要结局
Blood pressure measurement in both arms
时间窗: 5minutes
The systolic blood pressure, diastolic blood pressure and pulse rate of the left and right upper arms were simultaneously measured by a standard dual-arm electronic sphygmomanometer. A total of 6 data were collected. A total of 30 data were collected and measured for 5 times without interruption, which was used to judge the functional balance state of "Zang-fu regional tissues" in human body.
次要结局
- Pittsburgh Sleep Quality Index (PSQI）(5minutes)
- Hamilton Anxiety Scale (HAMA)(5minutes)
- Gastrointestinal Symptom Scale(5minutes)
- Grade table of main disorders of liver and spleen(5minutes)
- Hamilton Depression Scale (HAMD)(5minutes)
- Pulse diagnosis information(10minutes)
研究者
Liyun He
Director of TCM Clinical Efficacy Evaluation Center
China Academy of Chinese Medical Sciences