The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients by Ear Pills Combined With Shengmai Capsule
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The measurement of blood pressure
研究概览
简要总结
This clinical study is to observe the improvement of MHD (maintenance hemodialysis) patients, quality of life，after applying therapy combining Auriculotherapy and Shengmai capsule. As a compliment to each other, Traditional Chinese Medicine and Modern Medicine form a joint and help improving life quality of MHD patients. Through the therapy, MHD patients, symptoms of thirst are improved, the incidence of intradialytic hypotension is reduced, the intake of water and sodium is lessen and the weight gain during dialysis is controlled, which consequently reduce cardiovascular and cerebrovascular complications and eventually reduce the mortality of MHD patients. Aiming to improve patients, thirst symptom and reduce the incidence of intradialytic hypotension, this study prospectively followed 144 MHD patients using multicenter prospective randomized crossover controlled clinical studies, using KT/V, URR, improvement of thirst, blood pressure and cognitive assessment as observational index. Multiple questionnaire surveys are conducted to understand patients, life quality from different angle. The use of Auriculotherapy is simple and effective and Shengmai capsule conforms to patients, syndrome, which is consistent with TCMs principle of "syndrome differentiation and treatment"and the theory of preventive treatment. The study not only expends the use of TMC in hemodialysis treatment, but also suggests a set of easy therapeutic schedules to improve the quality of life in patients receiving hemodialysis treatment.
详细描述
3.1 research object 3.1.1 case: 3.1.1.1 Beijing University of Chinese Medicine Dongzhimen hospital 48 cases 3.1.1.2 54 cases of Oriental Hospital of Beijing University of Chinese Medicine 3.1.1.3 Chinese Academy of traditional Chinese medicine, Wangjing Hospital, 20 cases 3.1.1.4 28 case of Beijing Pinggu Hospital of Traditional Chinese Medicine 3.1.2 diagnostic criteria: 3.1.2.1: syndrome score standard: according to the traditional Chinese medicine clinical research guiding principle (2002), chronic renal failure syndrome of deficiency of both qi and Yin compiled score table and determine the inclusion criteria.
Diagnostic criteria of hypotension in 3.1.2.2:
Referring to the Ministry of health of the people's Republic of China promulgated the "blood purification standard operating procedures (2010 Edition)" in the "blood dialysis hypotension prevention and control standards for the prevention and control of standard operating procedures", the diagnostic criteria are as follows: (1) can be diagnosed: (1) systolic blood pressure reduction of more than 20mmHg; (2) the average arterial pressure decreased more than 10mmHg.
3.1.2.3 mouth thirst intensity score The investigators will mouth thirst intensity score table (XQ) eight problems in the translation into Chinese questionnaire, each question by visual rating scale method and by the patients according to their own scoring. The higher score indicated the mouth thirst more serious or mouth thirst caused discomfort heavier, and the summation of the scores of each question and convert it to a range of 0 to 100 score, resulting score higher mouth thirst more serious degree.
3.1.4.2 on the treatment of Chinese and Western medicine treatment of poor compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in the blood purification center hemodialysis (2-4 times / week, the same below) more than 3 months;
- •in line with the deficiency of both qi and Yin syndrome score greater than or equal to 9 points and thirsty XQ scores greater than or equal to 8 points; or deficiency of both qi and Yin syndrome score greater than or equal to 9 points and dialysis hypotension occurred frequency is greater than or equal to 1 / 5 of dialysis patients;
- •between 18-80, the condition is basically stable;
- •have better treatment compliance, signed informed consent.
排除标准
- •patients in the blood purification center of the law for less than 3 months.
- •the treatment of Chinese and Western medicine treatment of poor compliance.
- •infection, fever, acute heart failure or diabetes and blood glucose control is not ideal.
- •the patients with the capsule preparation and adhesive tape skin allergy.
- •patients unable to cooperate or not sign the informed consent.
研究组 & 干预措施
Ear pills and Shengmai capsule
On regular hemodialysis based on given auricular Ear pills and Shengmai capsule
干预措施: Ear pills (Drug)
Ear pills and Shengmai capsule
On regular hemodialysis based on given auricular Ear pills and Shengmai capsule
干预措施: Shengmai capsule (Drug)
结局指标
主要结局
The measurement of blood pressure
时间窗: 8 weeks
According to the diagnostic criteria of hypotension in hemodialysis patients， To summarize the incidence of hypotension in the experimental group and the control group.
次要结局
未报告次要终点
研究者
Cao po
Chief physician, Professor, master's tutor
Beijing University of Chinese Medicine