Chronic Kidney DiseasePhase 3NCT02545036
Combined Western and Traditional Chinese Medicine Daycare for CKD Patients
A Phase 3 study testing Traditional Chinese Medicine (TCM) daycare model in people with Chronic Kidney Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Traditional Chinese Medicine (TCM) daycare model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to 20 Sep 2017
- 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
- 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.
Who cannot join
- 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.
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- 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.
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
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.
Read the detailed description
Keywords：chronic kidney disease , Day care, Traditional Chinese Medicine(TCM)
Background and purpose:
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.
Material and methods:
A total of 60 volunteers of patients with chronic kidney disease will be recruited from the Chinese medicine or Western medicine clinics. After diagnosis by nephrology physician, 30 patients will be distributed to combinational Western and TCM daycare model, one time a week, for 12 weeks (12 treatment in total). Another 30 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 and the 5-D itch scale will be completed at baseline, 6weeks, and 12 weeks after join this study. Instrumental examinations including heart rate variability and traditional Chinese medicine four examinations 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 superior to the "pre-ESRD prevention and education program" which execute since 2006 in improving edema, fatigue, physical function and quality of life. The effectiveness of combined therapy can be measured by questionnaires. Moreover, the investigators will further speculate the mechanism by analyzing laboratory data.
- Conditions
- Chronic Kidney Disease
- Being tested
- Traditional Chinese Medicine (TCM) daycare model
- Keywords
- chronic kidney disease, Daycare, Traditional Chinese Medicine(TCM)
- Medical subject headings
- Renal Insufficiency, Chronic
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 | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Creatinine(mg/dL) at 3 months
Measured: baseline,12th week
Change from Baseline in GFR(ml/min/1.73m2)at 3 months
Measured: baseline,12th week
Secondary outcomes (9)
The Pittsburgh Sleep Quality Index
Measured: baseline, 6th ,12th week
Beck Depression Inventory II
Measured: baseline, 6th ,12th week
FACIT-fatigue scale
Measured: baseline, 6th ,12th week
The 5-D itch scale
Measured: baseline, 6th ,12th week
skin pruritus on Visual Analogue Scale
for skin pruritus
Measured: baseline, 6th ,12th week
TCM body constitution questionnaire
Measured: baseline, 6th ,12th week
heart rate variability
Measured: baseline, 12th week
TCM diagnosis
Measured: baseline, 12th week
SF-36 Health Survey
Measured: baseline, 6th ,12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJun 2015
- Primary completion1 Nov 2016
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- 58 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
- NCT02545036
- Sponsor's protocol ID
- CMUH104-REC1-041
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2015
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 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
- NCT02545036
- Acronym / sponsor ID
- CMUH104-REC1-041
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, Daycare, Traditional Chinese Medicine(TCM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- Jun 2015
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 9 Sep 2015 (estimated)
- 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.
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.
Detailed description
Keywords：chronic kidney disease , Day care, Traditional Chinese Medicine(TCM)
Background and purpose:
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.
Material and methods:
A total of 60 volunteers of patients with chronic kidney disease will be recruited from the Chinese medicine or Western medicine clinics. After diagnosis by nephrology physician, 30 patients will be distributed to combinational Western and TCM daycare model, one time a week, for 12 weeks (12 treatment in total). Another 30 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 and the 5-D itch scale will be completed at baseline, 6weeks, and 12 weeks after join this study. Instrumental examinations including heart rate variability and traditional Chinese medicine four examinations 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 superior to the "pre-ESRD prevention and education program" which execute since 2006 in improving edema, fatigue, physical function and quality of life. 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 model30 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 | –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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 Creatinine(mg/dL) at 3 months
Time frame: baseline,12th week
Change from Baseline in GFR(ml/min/1.73m2)at 3 months
Time frame: baseline,12th week
9 secondary outcomes
The Pittsburgh Sleep Quality Index
Time frame: baseline, 6th ,12th week
Beck Depression Inventory II
Time frame: baseline, 6th ,12th week
FACIT-fatigue scale
Time frame: baseline, 6th ,12th week
The 5-D itch scale
Time frame: baseline, 6th ,12th week
skin pruritus on Visual Analogue Scale
Time frame: baseline, 6th ,12th week
TCM body constitution questionnaire
Time frame: baseline, 6th ,12th week
heart rate variability
Time frame: baseline, 12th week
TCM diagnosis
Time frame: baseline, 12th week
SF-36 Health Survey
Time frame: baseline, 6th ,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 2 Aug 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 Chronic Kidney Disease, 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 4 inclusion and 13 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 2 Aug 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 Creatinine(mg/dL) at 3 months (time frame: baseline,12th week). The study lists 2 primary outcomes in all. 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 2 Aug 2021.