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

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ClinicalTrials.gov Identifier: NCT02583802
Recruitment Status : Unknown
Verified October 2015 by Cao po, Beijing University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Sponsor:
Collaborators:
Wang Jing Hospital
Beijing First Hospital of integrated Chinese and Western Medicine
Dongfang Hospital Beijing University of Chinese Medicine
Information provided by (Responsible Party):
Cao po, Beijing University of Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Intradialytic Hypotension Drug: Ear pills Drug: Shengmai capsule Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients by Ear Pills Combined With Shengmai Capsule
Study Start Date : September 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
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.
Experimental: Ear pills and Shengmai capsule
On regular hemodialysis based on given auricular Ear pills and Shengmai capsule
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.




Primary Outcome Measures :
  1. The measurement of blood pressure [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583802


Contacts
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Contact: Beijing University of Chinese Medicine Beijing University of Chinese Medicine csdoctor1988@163.com
Contact: Beijing University of Chinese Medicine Beijing University of Chinese Medicine

Locations
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China, Beijing
Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100029
Contact: Beijing University of Chinese Medicine       csdoctor1988@163.com   
Sponsors and Collaborators
Beijing University of Chinese Medicine
Wang Jing Hospital
Beijing First Hospital of integrated Chinese and Western Medicine
Dongfang Hospital Beijing University of Chinese Medicine
Investigators
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Principal Investigator: Beijing University of Chinese Medicine Beijing University of Chinese Medicine Chinese Ministry of Education
Publications:
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Responsible Party: Cao po, Chief physician, Professor, master's tutor, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02583802    
Other Study ID Numbers: 2013-ZYLC-003
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Keywords provided by Cao po, Beijing University of Chinese Medicine:
MHD
ear pills
Shengmai capsule
Chinese medicine treatment
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases