Combined Western and Traditional Chinese Medicine Daycare for DM Nephropathy Patients

NCT ID: NCT05038046

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-05-16

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.

Conditions

Diabetes Mellitus Nephropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TCM daycare model

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.

Group Type: EXPERIMENTAL

Traditional Chinese Medicine (TCM) daycare model

Intervention Type: 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).

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Welfare, Taiwan

OTHER_GOV

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH 104-REC3-117

Identifier Type: -

Identifier Source: org_study_id