NCT02583802

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

October 13, 2015

Last Update Submit

October 21, 2015

Conditions

Intradialytic Hypotension

Keywords

MHDear pillsShengmai capsuleChinese medicine treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control group

NO INTERVENTION

Control group received regular hemodialysis treatment, no given Ear pills and Shengmai capsule completed in the treatment of the first stage. After 4 weeks after a washout period, two groups of cross accept the next phase of treatment.

Ear pills and Shengmai capsule

EXPERIMENTAL

On regular hemodialysis based on given auricular Ear pills and Shengmai capsule

Drug: Ear pillsDrug: Shengmai capsule

Interventions

Ear pillsDRUG

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.

Ear pills and Shengmai capsule
Shengmai capsuleDRUG

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

Ear pills and Shengmai capsule

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (4)

  • Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):695-704. doi: 10.1016/s0360-3016(01)01512-7.

    PMID: 11395238BACKGROUND

  • Jabbari S, Kim HM, Feng M, Lin A, Tsien C, Elshaikh M, Terrel JE, Murdoch-Kinch C, Eisbruch A. Matched case-control study of quality of life and xerostomia after intensity-modulated radiotherapy or standard radiotherapy for head-and-neck cancer: initial report. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):725-31. doi: 10.1016/j.ijrobp.2005.02.045.

    PMID: 16199308BACKGROUND

  • Lin A, Kim HM, Terrell JE, Dawson LA, Ship JA, Eisbruch A. Quality of life after parotid-sparing IMRT for head-and-neck cancer: a prospective longitudinal study. Int J Radiat Oncol Biol Phys. 2003 Sep 1;57(1):61-70. doi: 10.1016/s0360-3016(03)00361-4.

    PMID: 12909216BACKGROUND

  • Pacholke HD, Amdur RJ, Morris CG, Li JG, Dempsey JF, Hinerman RW, Mendenhall WM. Late xerostomia after intensity-modulated radiation therapy versus conventional radiotherapy. Am J Clin Oncol. 2005 Aug;28(4):351-8. doi: 10.1097/01.coc.0000158826.88179.75.

    PMID: 16062076BACKGROUND

MeSH Terms

Interventions

fructus schizandrae, radix ginseng, radix ophiopogonis drug combination

Study Officials

  • Beijing University of Chinese Medicine Beijing University of Chinese Medicine

    Chinese Ministry of Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beijing University of Chinese Medicine Beijing University of Chinese Medicine

CONTACT

csdoctor1988@163.com

Beijing University of Chinese Medicine Beijing University of Chinese Medicine

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician, Professor, master's tutor

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 22, 2015

Study Start

September 1, 2013

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

CN(1)