Chronic Kidney DiseasesNCT06588465
Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients
A study testing On-venous Laser Irradiation of Blood and low dose On-venous Laser Irradiation of Blood in people with Chronic Kidney Diseases and Proteinuria, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The single center, randomized, assessor- and participant-blind, controlled, cross-over on-venous laser irradiation of blood clinical trial was performed to analyze patients with DKD. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Proteinuria, Diabetes Mellitus
- What is being tested?
- On-venous Laser Irradiation of Blood and low dose On-venous Laser Irradiation of Blood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HbA1C≥6.5 % and ≤ 9%, ±0.5% under past three months
- eGFR ≥30ml/min/1.73m2 and protinuria ≥30mg/d under ACEI or ARB treatment
Who cannot join
- allergic to laser beans
- Immunosuppressive drugs had been used in the past six months
- urine protein over 3.5 g /day
- Autosomal dominant polycystic kidney disease
- Lupus nephritis
- People with mental illness or other mental disabilities are unable to cooperate with the researcher.
- Those who used non-steroidal analgesics and steroids in the trial period
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients: A Single Center, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial
The single center, randomized, assessor- and participant-blind, controlled, cross-over on-venous laser irradiation of blood clinical trial was performed to analyze patients with DKD. The information will help to whether integration of laser acupuncture into patient care will help to improve the clinical symptoms and quality of life.
Read the detailed description
Microalbuminuria is the cardinal symptom of diabetes kidney disease (DKD) and is linked to renal function decline. The cardiovascular risk of patients with DKD is much higher than that of the general population, and cardiovascular diseases is the main cause of death in patients with DKD.
We plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to on-venous laser irradiation of blood and low dose OLIB group. Each group will include 36 patients and given intervention three times a week. The intervention will then be crossed over to the other one after 1 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, urine routine analysis.
- Conditions
- Chronic Kidney Diseases, Proteinuria, Diabetes Mellitus
- Being tested
- On-venous Laser Irradiation of Blood, low dose On-venous Laser Irradiation of Blood
- Keywords
- Chronic Kidney Diseases, diabetes mellitus
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-venous Laser Irradiation of BloodDevice
The treatment will take place three times a week, over six weeks. The On-venous Laser will placed in the body for 60 minutes. A total of 15 laser heads (15 acupoints, bilaterally) will be used in each session.
low dose On-venous Laser Irradiation of BloodDevice
The treatment will take place three times a week, over six weeks. The low dose On-venous Laser will placed in the body for 60 minutes. A total of 15 laser heads (15 acupoints, bilaterally) will be used in each session.
| Study group | Role | What they receive |
|---|---|---|
| treatment group A | Experimental | We plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to treatment group A or group B. Receives: Device: On-venous Laser Irradiation of Blood; Device: low dose On-venous Laser Irradiation of Blood |
| treatment group B | Experimental | We plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to treatment group A or group B. Receives: Device: On-venous Laser Irradiation of Blood; Device: low dose On-venous Laser Irradiation of Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the spot proteinuria changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.
A spot urine P/C ratio \>20 mg/mmol (0.2 mg/mg) is the most commonly reported cutoff value for detecting proteinuria
Measured: baseline, 6 weeks, 13weeks
Examine the eGFR changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.
eGFR (estimated glomerular filtration rate) is a measure of how well your kidneys are working. Your eGFR is an estimated number based on a blood test and your age, sex, and body type.
Measured: baseline, 6 weeks, 13weeks
Examine the albuminuria changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.
A ratio of albumin (mcg/L) to creatinine (mg/L) of less than 30 is normal; a ratio of 30-300 signifies microalbuminuria and values above 300 are considered as macroalbuminuria.
Measured: baseline, 6 weeks, 13weeks
Secondary outcomes (1)
SF-36
The 36-Item Short Form Survey (SF-36) is outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.It comprises 36 questions that cover eight domains of health
Measured: baseline, 6 weeks, 13weeks, 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
- Investigators
- YU-CHEN LEE, Ph.D, Study director, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588465
- Sponsor's protocol ID
- CMUH113-REC1-062
- Status last verified
- May 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu S, Zhang F, Bai Y, Huang L, Zhong Y, Li Y. Therapeutic effects of acupuncture therapy for kidney function and common symptoms in patients with chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2024 Dec;46(1):2301504. doi: 10.1080/0886022X.2023.2301504. Epub 2024 Jan 8.
PubMed 38189090Chuang SM, Lee CC, Lo WY, Hsieh CL. Effect of acupressure at Sanyinjiao on albuminuria in patients with early diabetic nephropathy: A single-blind, randomized, controlled preliminary study. Explore (NY). 2020 May-Jun;16(3):165-169. doi: 10.1016/j.explore.2019.09.001. Epub 2019 Sep 21.
PubMed 31591045
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients: A Single Center, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT06588465
- Acronym / sponsor ID
- CMUH113-REC1-062
- Conditions
- Chronic Kidney Diseases, Proteinuria, Diabetes Mellitus
- Keywords
- Chronic Kidney Diseases, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
The single center, randomized, assessor- and participant-blind, controlled, cross-over on-venous laser irradiation of blood clinical trial was performed to analyze patients with DKD. The information will help to whether integration of laser acupuncture into patient care will help to improve the clinical symptoms and quality of life.
Detailed description
Microalbuminuria is the cardinal symptom of diabetes kidney disease (DKD) and is linked to renal function decline. The cardiovascular risk of patients with DKD is much higher than that of the general population, and cardiovascular diseases is the main cause of death in patients with DKD.
We plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to on-venous laser irradiation of blood and low dose OLIB group. Each group will include 36 patients and given intervention three times a week. The intervention will then be crossed over to the other one after 1 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, urine routine analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group A | Experimental | Device: On-venous Laser Irradiation of Blood, Device: low dose On-venous Laser Irradiation of BloodWe plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to treatment group A or group B. |
| treatment group B | Experimental | Device: On-venous Laser Irradiation of Blood, Device: low dose On-venous Laser Irradiation of BloodWe plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to treatment group A or group B. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HbA1C≥6.5 % and ≤ 9%, ±0.5% under past three months
- eGFR ≥30ml/min/1.73m2 and protinuria ≥30mg/d under ACEI or ARB treatment
Key exclusion criteria (8 listed)
- allergic to laser beans
- Immunosuppressive drugs had been used in the past six months
- urine protein over 3.5 g /day
- Autosomal dominant polycystic kidney disease
- Lupus nephritis
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 |
|---|---|---|
| On-venous Laser Irradiation of BloodThe treatment will take place three times a week, over six weeks. The On-venous Laser will placed in the body for 60 minutes. A total of 15 laser heads (15 acupoints, bilaterally) will be used in each session. | Device | treatment group A, treatment group B |
| low dose On-venous Laser Irradiation of BloodThe treatment will take place three times a week, over six weeks. The low dose On-venous Laser will placed in the body for 60 minutes. A total of 15 laser heads (15 acupoints, bilaterally) will be used in each session. | Device | treatment group A, treatment group B |
Primary outcome
Examine the spot proteinuria changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.
Time frame: baseline, 6 weeks, 13weeks
A spot urine P/C ratio \>20 mg/mmol (0.2 mg/mg) is the most commonly reported cutoff value for detecting proteinuria
Examine the eGFR changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.
Time frame: baseline, 6 weeks, 13weeks
eGFR (estimated glomerular filtration rate) is a measure of how well your kidneys are working. Your eGFR is an estimated number based on a blood test and your age, sex, and body type.
Examine the albuminuria changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.
Time frame: baseline, 6 weeks, 13weeks
A ratio of albumin (mcg/L) to creatinine (mg/L) of less than 30 is normal; a ratio of 30-300 signifies microalbuminuria and values above 300 are considered as macroalbuminuria.
1 secondary outcome
SF-36
Time frame: baseline, 6 weeks, 13weeks, 17 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 38189090Liu S, Zhang F, Bai Y, Huang L, Zhong Y, Li Y. Therapeutic effects of acupuncture therapy for kidney function and common symptoms in patients with chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2024 Dec;46(1):2301504. doi: 10.1080/0886022X.2023.2301504. Epub 2024 Jan 8.
- Results publication: PubMed 31591045Chuang SM, Lee CC, Lo WY, Hsieh CL. Effect of acupressure at Sanyinjiao on albuminuria in patients with early diabetic nephropathy: A single-blind, randomized, controlled preliminary study. Explore (NY). 2020 May-Jun;16(3):165-169. doi: 10.1016/j.explore.2019.09.001. Epub 2019 Sep 21.
- Individual participant dataSharing planned: No
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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.
YU-CHEN LEE, Ph.D study director
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-venous Laser Irradiation of Blood and low dose On-venous Laser Irradiation of Blood in people with Chronic Kidney Diseases and Proteinuria, 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 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Examine the spot proteinuria changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week. (time frame: baseline, 6 weeks, 13weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588465, which also lists 2 linked publications.
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 19 Sep 2024.