Intradialytic Hypotension Clinical Trial
Official title:
The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients by Ear Pills Combined With Shengmai Capsule
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. in the blood purification center hemodialysis (2-4 times / week, the same below) more than 3 months; 2. 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; 3. between 18-80, the condition is basically stable; 4. have better treatment compliance, signed informed consent. Exclusion Criteria: 1. patients in the blood purification center of the law for less than 3 months. 2. the treatment of Chinese and Western medicine treatment of poor compliance. 3. infection, fever, acute heart failure or diabetes and blood glucose control is not ideal. 4. the patients with the capsule preparation and adhesive tape skin allergy. 5. patients unable to cooperate or not sign the informed consent. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing University of Chinese Medicine | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing University of Chinese Medicine | Beijing First Hospital of integrated Chinese and Western Medicine, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Wang Jing Hospital |
China,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The measurement of blood pressure | According to the diagnostic criteria of hypotension in hemodialysis patients, To summarize the incidence of hypotension in the experimental group and the control group. | 8 weeks | Yes |
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