The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients

Summary

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.

Conditions

• Intradialytic Hypotension

Interventions

DRUG

Ear pills

The clinical design of this study was a randomized crossover trial. This experiment research is divided into two stages, each stage is 8 weeks. After 4 weeks after a washout period, two groups of cross accept the next phase of treatment.

DRUG

Shengmai capsule

The clinical design of this study was a randomized crossover trial. This experiment research is divided into two stages, each stage is 8 weeks.

Sponsors & Collaborators

• Wang Jing Hospital

  collaborator OTHER

• Beijing First Hospital of integrated Chinese and Western Medicine

  collaborator OTHER

• Dongfang Hospital Beijing University of Chinese Medicine

  collaborator OTHER

• Beijing University of Chinese Medicine

  lead OTHER

Principal Investigators

• Beijing University of Chinese Medicine Beijing University of Chinese Medicine · Chinese Ministry of Education

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2015-10-31

Completion

2015-12-31

Countries

• China

Study Locations