Combined Western and Traditional Chinese Medicine Daycare for CKD Patients

NCT02545036 | Completed Phase 3

• 1 other identifier: CMUH104-REC1-041
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; Daycare; Traditional Chinese Medicine(TCM)

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Creatinine(mg/dL) at 3 months

  baseline,12th week

• Change from Baseline in GFR(ml/min/1.73m2)at 3 months

  baseline,12th week

Secondary Outcomes (9)

• The Pittsburgh Sleep Quality Index

  baseline, 6th ,12th week

• Beck Depression Inventory II

  baseline, 6th ,12th week

• FACIT-fatigue scale

  baseline, 6th ,12th week

• The 5-D itch scale

  baseline, 6th ,12th week

• skin pruritus on Visual Analogue Scale

  baseline, 6th ,12th week

Study Arms (2)

TCM daycare model

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Traditional Chinese Medicine (TCM) daycare model OTHER

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).

TCM daycare model

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: September 9, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: September 20, 2017
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

TW (1)