Combined Western and Traditional Chinese Medicine Daycare for DM Nephropathy Patients

NCT05038046 | Completed Phase 3

• 1 other identifier: CMUH 104-REC3-117
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus Nephropathy

Keywords

Diabetes mellitus nephropathy; Daycare; Traditional Chinese Medicine(TCM)

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Nerve Conduction Velocity at 3 months

  a test to see how fast electrical signals move through a nerve. This test is done along with electromyography (EMG) to assess the muscles for abnormalities.

  1st,12th week

Secondary Outcomes (11)

• The Pittsburgh Sleep Quality Index

  1st,12th week

• Beck Depression Inventory II

  1st,12th week

• The Functional Assessment of Chronic Illness Therapy-fatigue scale

  1st,12th week

• Brief Pain Inventory (BPI) short form

  1st,12th week

• Traditional Chinese Medicine body constitution questionnaire

  1st,12th week

Study Arms (2)

TCM daycare model

EXPERIMENTAL

15 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

15 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:

• Diabetic peripheral neuropathy based on subjective symptoms
• 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).
• 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:

• primary cause of neurologic disorder was not diabetes (e.g., alcoholic neuropathy, carpal tunnel syndrome, chemotherapy induced neuropathy)
• receiving other experimental medications for DPN or any other medication that affects symptoms of DPN
• ankle brachial pressure index of ≤ 0.8
• 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.

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

Interventions

Medicine, Chinese Traditional

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: May 31, 2016
• First Posted: September 8, 2021
• Study Start: March 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: May 16, 2018
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

TW (1)