Clinical trial NCT05038046: Combined Western and Traditional Chinese Medicine Daycare for DM Nephropathy Patients
Official title: Clinical Study of Combined Western Medicine and Traditional Chinese Medicine Daycare Model for Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Nephropathy
Keywords: Diabetes mellitus nephropathy
Daycare
Traditional Chinese Medicine(TCM)
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2021-09-08
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic nephropathy is not only an important issue of national health, but also a disease that TCM can play an important role. The aim of this project is to build up a TCM clinical daycare model for diabetic nephropathy patients, and to establish a teaching platform for TCM trainees. The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists, nutritionist and case managers. This model will provide a comprehensive TCM care system to improve the clinical symptoms and quality of life of diabetic nephropathy patients. The teaching platform of the TCM daycare clinics for diabetic nephropathy patients will provide a good clinical training environment for the trainees. They can learn how to take care ofdiabetic nephropathy patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors

Detailed description: keywords᧶Diabetic Nephropathy, Daycare, Traditional Chinese Medicine (TCM) Diabetic nephropathy is not only an important issue of national health, but also a disease that TCM can play an important role. The aim of this project is to build up a TCM clinical daycare model for diabetic nephropathy patients, and to establish a teaching platform for TCM trainees. The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists, nutritionist and case managers. This model will provide a comprehensive TCM care system to improve the clinical symptoms and quality of life of diabetic nephropathy patients. The teaching platform of the TCM daycare clinics for diabetic nephropathy patients will provide a good clinical training environment for the trainees. They can learn how to take care ofdiabetic nephropathy patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors.

Material and methods:

A total of 30 volunteers of patients with Diabetic nephropathy will be recruited from the Chinese medicine or Western medicine clinics. After diagnosis by nephrology physician, 15 patients will be distributed to combinational Western and TCM daycare model, one time a week, for 12 weeks (12 treatment in total). Another 15 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, the Galer Jensen Neuropathic Pain Scale, SF-BPI, TC-AE, and constitution in Chinese medicine questionnaire will be completed at 1 weeks, and 12 weeks after join this study. Instrumental examinations including heart rate variability 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 improving neuropathy symptoms, edema, fatigue, physical function and quality of life in diabetic nephropathy patients. The effectiveness of combined therapy can be measured by questionnaires. Moreover, the investigators will further speculate the mechanism by analyzing laboratory data.

Eligibility criteria: Inclusion Criteria:

1. Diabetic peripheral neuropathy based on subjective symptoms
2. Fit diabetes mellitus nephropathy definition by National Kidney Foundation's Kidney Disease Outcome Quality Initiative（NKF-KDOQI) stage II\~IV and fit American Diabetic Association Criteria by stable glycemic control (HbA1C ≤ 9%, with ± 0.5% variation in the previous 3months).
3. at least 20 years old volunteers.
4. The participants had no allergy to acupuncture needle in the past, or without contraindications to acupuncture treatment.
5. The participants agreed to join the trial and sign informed consent form after thorough explanation.

Exclusion Criteria:

1. primary cause of neurologic disorder was not diabetes (e.g., alcoholic neuropathy, carpal tunnel syndrome, chemotherapy induced neuropathy)
2. receiving other experimental medications for DPN or any other medication that affects symptoms of DPN
3. ankle brachial pressure index of ≤ 0.8
4. Had substance abuse in the past, or having substance abuse.
5. Pregnancy women or breastfeeding women.
6. Mental or behavioral disorders which leads to inability to cooperation.
7. Arrhythmia patients who have pacemaker.
8. Patient who have skin infection or wound infection near acupoints.

Primary outcomes:
measure: Change from Baseline in Nerve Conduction Velocity at 3 months
timeFrame: 1st,12th week
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: 1st,12th week
measure: Beck Depression Inventory II
timeFrame: 1st,12th week
measure: The Functional Assessment of Chronic Illness Therapy-fatigue scale
timeFrame: 1st,12th week
measure: Brief Pain Inventory (BPI) short form
timeFrame: 1st,12th week
measure: Traditional Chinese Medicine body constitution questionnaire
timeFrame: 1st,12th week
measure: Galer Jensen Neuropathic Pain Scale
timeFrame: 1st,12th week
measure: Common Terminology Criteria for Adverse Events
timeFrame: 1st,12th week
measure: Change from Baseline in Creatinine(mg/dL) at 3 months
timeFrame: 1st,12th week
measure: Change from Baseline in GFR(ml/min/1.73m2)at 3 months
timeFrame: 1st,12th week
measure: 36-Item Short Form Health Survey
timeFrame: 1st,12th week
measure: heart rate variability
timeFrame: 1st,12th week
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: