Diabetes Mellitus NephropathyPhase 3NCT05038046
Combined Western and Traditional Chinese Medicine Daycare for DM Nephropathy Patients
A Phase 3 study testing Traditional Chinese Medicine (TCM) daycare model in people with Diabetes Mellitus Nephropathy, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus Nephropathy
- What is being tested?
- Traditional Chinese Medicine (TCM) daycare model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2016to 16 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Combined Western Medicine and Traditional Chinese Medicine Daycare Model for Chronic Kidney Disease Patients
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
Read the 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
- Being tested
- Traditional Chinese Medicine (TCM) daycare model
- Keywords
- Diabetes mellitus nephropathy, Daycare, Traditional Chinese Medicine(TCM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine (TCM) daycare modelOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st,12th week
Secondary outcomes (11)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses multiple dimensions of sleep over a 1-month time period.
Measured: 1st,12th week
Beck Depression Inventory II
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). The BDI has been developed in different forms, including several computerized forms, a card form (May, Urquhart, Tarran, 1969, cited in Groth-Marnat, 1990), the 13-item short form and the more recent BDI-II by Beck, Steer \& Brown, 1996.
Measured: 1st,12th week
The Functional Assessment of Chronic Illness Therapy-fatigue scale
short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Measured: 1st,12th week
Brief Pain Inventory (BPI) short form
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
Measured: 1st,12th week
Traditional Chinese Medicine body constitution questionnaire
The 60 items Constitution in Chinese Medicine Questionnaire
Measured: 1st,12th week
Galer Jensen Neuropathic Pain Scale
to assess distinct pain qualities associated with neuropathic pain.
Measured: 1st,12th week
Common Terminology Criteria for Adverse Events
a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
Measured: 1st,12th week
Change from Baseline in Creatinine(mg/dL) at 3 months
renal function
Measured: 1st,12th week
Change from Baseline in GFR(ml/min/1.73m2)at 3 months
renal function
Measured: 1st,12th week
36-Item Short Form Health Survey
is a set of generic, coherent, and easily administered quality-of-life measures.
Measured: 1st,12th week
heart rate variability
Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval.
Measured: 1st,12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study startMar 2016
- Primary completion31 Dec 2017
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus NephropathyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038046
- Sponsor's protocol ID
- CMUH 104-REC3-117
- Status last verified
- Aug 2021
- First submitted
- 31 May 2016
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Combined Western Medicine and Traditional Chinese Medicine Daycare Model for Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05038046
- Acronym / sponsor ID
- CMUH 104-REC3-117
- Conditions
- Diabetes Mellitus Nephropathy
- Keywords
- Diabetes mellitus nephropathy, Daycare, Traditional Chinese Medicine(TCM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- Mar 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM daycare model | Experimental | Other: Traditional Chinese Medicine (TCM) daycare model15 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine (TCM) daycare modelTraditional 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). | Other | TCM daycare model |
Primary outcome
Change from Baseline in Nerve Conduction Velocity at 3 months
Time frame: 1st,12th week
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.
11 secondary outcomes
The Pittsburgh Sleep Quality Index
Time frame: 1st,12th week
Beck Depression Inventory II
Time frame: 1st,12th week
The Functional Assessment of Chronic Illness Therapy-fatigue scale
Time frame: 1st,12th week
Brief Pain Inventory (BPI) short form
Time frame: 1st,12th week
Traditional Chinese Medicine body constitution questionnaire
Time frame: 1st,12th week
Galer Jensen Neuropathic Pain Scale
Time frame: 1st,12th week
Common Terminology Criteria for Adverse Events
Time frame: 1st,12th week
Change from Baseline in Creatinine(mg/dL) at 3 months
Time frame: 1st,12th week
Change from Baseline in GFR(ml/min/1.73m2)at 3 months
Time frame: 1st,12th week
36-Item Short Form Health Survey
Time frame: 1st,12th week
heart rate variability
Time frame: 1st,12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traditional Chinese Medicine (TCM) daycare model in people with Diabetes Mellitus Nephropathy, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Nerve Conduction Velocity at 3 months (time frame: 1st,12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.