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Trial record 11 of 3339 for:    China Medicine University Hospital

Combined Western and Traditional Chinese Medicine Daycare for CKD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02545036
Recruitment Status : Unknown
Verified September 2015 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : September 9, 2015
Last Update Posted : September 9, 2015
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:

The annual report of USRDS shows than Taiwan has the highest prevalence of end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors associated with chronic renal failure are age, diabetes, hypertension, chronic glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And these possible prognostic factors associating with the disease progression and ultimately increase the morbidity and mortality. End-stage renal failure is an irreversible course often with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often use Chinese medicine or acupuncture to help them to ease the symptom.

The aim of this study is to investigate the efficacy of combined Western medicine and traditional Chinese medicine daycare model for chronic kidney disease patients. The study approach to investigate whether combination of Western medicine and traditional Chinese medicine daycare model can improve the clinical symptoms and quality of life as well as the laboratory biochemistries data.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Traditional Chinese Medicine (TCM) daycare model Phase 3

Detailed Description:

Keywords:chronic kidney disease , Day care, Traditional Chinese Medicine(TCM)

Background and purpose:

The annual report of USRDS shows than Taiwan has the highest prevalence of end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors associated with chronic renal failure are age, diabetes, hypertension, chronic glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And these possible prognostic factors associating with the disease progression and ultimately increase the morbidity and mortality. End-stage renal failure is an irreversible course often with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often use Chinese medicine or acupuncture to help them to ease the symptom.

The aim of this study is to investigate the efficacy of combined Western medicine and traditional Chinese medicine daycare model for chronic kidney disease patients. The study approach to investigate whether combination of Western medicine and traditional Chinese medicine daycare model can improve the clinical symptoms and quality of life as well as the laboratory biochemistries data.

Material and methods:

A total of 60 volunteers of patients with chronic kidney disease will be recruited from the Chinese medicine or Western medicine clinics. After diagnosis by nephrology physician, 30 patients will be distributed to combinational Western and TCM daycare model, one time a week, for 12 weeks (12 treatment in total). Another 30 patients will enter Western daycare model. The assignment depends on the patients' own will. The TCM day care model will be provided by a team work clinical care system organized by doctors, nurses, pharmacists and case managers. This model will provide a comprehensive TCM care system for every visit. Laboratory biochemistries analysis and other questionnaires including SF36 health survey, Pittsburgh Sleep Quality Index, Beck Depression Inventory-II, FACIT-fatigue Scale and the 5-D itch scale will be completed at baseline, 6weeks, and 12 weeks after join this study. Instrumental examinations including heart rate variability and traditional Chinese medicine four examinations will be given before and after intervention.

Predict results:

The investigators expect that the efficacy of this combined western medicine and traditional Chinese medicine day care model will be superior to the "pre-ESRD prevention and education program" which execute since 2006 in improving edema, fatigue, physical function and quality of life. The effectiveness of combined therapy can be measured by questionnaires. Moreover, the investigators will further speculate the mechanism by analyzing laboratory data.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Combined Western Medicine and Traditional Chinese Medicine Daycare Model for Chronic Kidney Disease Patients
Study Start Date : June 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: TCM daycare model
30 patients will be assigned to this arm. The assignment depends on the patients' own will. After diagnosis by nephrology physician, these patients will be distributed to control group by their wills. The intervention is Traditional Chinese Medicine (TCM) daycare model, which provides multiple approaches of traditional Chinese medical treatment, including 5 tones of Chinese music, massage on meridians and collaterals, acupuncture, and patient education. The treatment course is one time a week, for 12 weeks (12 treatments in total). And the model will be provided by a team work clinical care system organized by doctors, nurses, pharmacists and case managers, also provide a comprehensive TCM care system for every visit.
Other: Traditional Chinese Medicine (TCM) daycare model
Traditional Chinese Medical (TCM) daycare model provides multiple approaches of traditional Chinese medical treatment, including 5 tones of Chinese music, massage for meridians and collaterals, acupuncture, and patient education. The treatment course is one time a week, for 12 weeks (12 treatments in total).

No Intervention: Control group
30 patients will be assigned to this arm. The assignment depends on the patients' own will. After diagnosis by nephrology physician, these patients will be distributed to control group by their wills. The control group will only receive assessment and follow-up without intervention.



Primary Outcome Measures :
  1. Change from Baseline in Creatinine(mg/dL) at 3 months [ Time Frame: baseline,12th week ]
  2. Change from Baseline in GFR(ml/min/1.73m2)at 3 months [ Time Frame: baseline,12th week ]

Secondary Outcome Measures :
  1. The Pittsburgh Sleep Quality Index [ Time Frame: baseline, 6th ,12th week ]
  2. Beck Depression Inventory II [ Time Frame: baseline, 6th ,12th week ]
  3. FACIT-fatigue scale [ Time Frame: baseline, 6th ,12th week ]
  4. The 5-D itch scale [ Time Frame: baseline, 6th ,12th week ]
  5. skin pruritus on Visual Analogue Scale [ Time Frame: baseline, 6th ,12th week ]
    for skin pruritus

  6. TCM body constitution questionnaire [ Time Frame: baseline, 6th ,12th week ]
  7. heart rate variability [ Time Frame: baseline, 12th week ]
  8. TCM diagnosis [ Time Frame: baseline, 12th week ]
  9. SF-36 Health Survey [ Time Frame: baseline, 6th ,12th week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fit CKD definition by National Kidney Foundation's Kidney Disease Outcome Quality Initiative(NKF-KDOQI, pre-ESRD stage IIIb~IV (GFR: 15-44).
  2. at least 20 years old volunteers.
  3. The participants had no allergy to acupuncture needle in the past, or without contraindications to acupuncture treatment.
  4. The participants agreed to join the trial and sign informed consent form after thorough explanation.

Exclusion Criteria:

  1. Age less than 20 years old.
  2. Using immunosuppressive drug or receiving chemotherapy.
  3. Had substance abuse in the past, or having substance abuse.
  4. Pregnancy women or breastfeeding women.
  5. Mental or behavioral disorders which leads to inability to cooperation.
  6. Arrhythmia patients who have pacemaker.
  7. Patient who have skin infection or wound infection near acupoints.
  8. Patient who have coagulation abnormalities or low platelet count by blood tests (platelet≤150000 / uL).
  9. Participating other clinical trials.
  10. Patient with serious diseases such as myocardial infarction, severe arrhythmia, heart failure, chronic obstructive airway disease, or cancer.
  11. Patients who have limb edema and severe skin lesions not suitable for acupuncture or massage.
  12. Patients who took Chinese herbal medicine or received acupuncture treatment in the past 2 weeks.
  13. Patients who disagree to sign informed consent form.

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): NCT02545036


Contacts
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Contact: Hung-Rong Yen, M.D., Ph.D. +886-4-22052121 ext 1672 hungrongyen@gmail.com
Contact: Yuan-Ching Liao, M.D. +886-4-22052121 ext 1670 squiet1026@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Hung-Rong Yen, M.D., Ph.D.    886-4-22052121 ext 7508    hungrongyen@gmail.com   
Contact: Yuan-Ching Liao, M.D.    886-4-22052121 ext 1670    squiet1026@gmail.com   
Principal Investigator: Hung-Rong Yen, M.D., Ph.D.         
Sponsors and Collaborators
China Medical University Hospital
Ministry of Health and Welfare, Taiwan

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02545036     History of Changes
Other Study ID Numbers: CMUH104-REC1-041
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by China Medical University Hospital:
chronic kidney disease
Daycare
Traditional Chinese Medicine(TCM)

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency