Investigating the effects of intravenous laser on the recovery of patients with chronic kidney disease is based on the creatinine and GFR
Design
Double-blind clinical trial, patients are divided into two control and treatment groups in a simple randomization. The rand function of Excel software was used for randomization.
Settings and conduct
The study will be conducted in Shahada Tajrish Hospital in a double-blind manner. Patients and treating nephrologists are unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
Patients with chronic kidney disease and consent is required to participate in the study and complete the treatment and follow-up process. Patients with pre-renal and post-renal acute kidney disease, patients with glomerulonephritis and patients who need immunosuppressive drugs, including lupus, patients who have taken omega-3 and corticosteroids in the last month, pregnant patients, sensitive to light and suffering from Malignancy is excluded from the study process.
Intervention groups
In the intervention group, intravenous laser works by using infrared rays from continuous or pulse infrared ((600-1100 nm) with an output power of 1-500 milliwatts). In this method, laser light is directly irradiated into the blood through a sterile disposable catheter. Two millimeters of optical fiber enters the vein and spreads into the blood circulation. This method is just like serum injection. In this study, it is for 7 sessions one day in between with a power of 2 milliwatts for 30 minutes.
The control group is the same as the intervention group, but with the laser turned off
Main outcome variables
BUN, Cr, GFR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N44
Registration date:2023-06-20, 1402/03/30
Registration timing:prospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of intravenous laser on creatinine and GFR in chronic kidney patients
Public title
Investigating the effects of intravenous laser on creatinine and GFR in chronic kidney patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a chronic kidney disease called CKD and with GFR below 20 who have not been treated with dialysis.
Exclusion criteria:
Patients with pre-renal and post-renal acute kidney disease, patients with glomerulonephritis and patients who need immunosuppressive drugs, including lupus, patients who have taken omega-3 and corticosteroids in the last month, pregnant patients, sensitive to light and suffering from malignancy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
All patients are divided into case and control groups based on the table of random numbers with a ratio of 1:1. The assigned group is placed in dark envelopes one after the other. This envelope will be opened by the treating doctor only after the initial evaluation of each person, and neither the patient nor the clinical evaluator will know about his treatment group. Etiology factors include sepsis, rhabdomyolysis and drugs in both match groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the control group, the Sham laser is used by the operator
And the reashercher and the patient are unaware of the type of group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of laser application in medical sciences research center
Intervention group: continuous or pulsed intravenous or near-infrared laser (600-1100 nm) with a power of 2 MW for 30 minutes, which is irradiated into the blood through a sterile disposable catheter. Two millimeters of optical fiber are inserted into the vein and distributed in the blood circulation. Intravenous laser is performed every other day for 7 sessions.