Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Chronic Kidney Diseases Proteinuria Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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treatment group A

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.

Group Type EXPERIMENTAL

On-venous Laser Irradiation of Blood

Intervention Type DEVICE

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 Blood

Intervention Type DEVICE

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.

treatment group B

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.

Group Type EXPERIMENTAL

On-venous Laser Irradiation of Blood

Intervention Type DEVICE

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 Blood

Intervention Type DEVICE

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.

Interventions

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On-venous Laser Irradiation of Blood

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.

Intervention Type DEVICE

low dose On-venous Laser Irradiation of Blood

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. HbA1C≥6.5 % and ≤ 9%, ±0.5% under past three months
2. eGFR ≥30ml/min/1.73m2 and protinuria ≥30mg/d under ACEI or ARB treatment

Exclusion Criteria

1. allergic to laser beans
2. Immunosuppressive drugs had been used in the past six months
3. urine protein over 3.5 g /day
4. Autosomal dominant polycystic kidney disease
5. Lupus nephritis
6. People with mental illness or other mental disabilities are unable to cooperate with the researcher.
7. Those who used non-steroidal analgesics and steroids in the trial period
8. Pregnant or lactating women

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes