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IRCT20111121008146N45 IRCT 2023-12-24 Shahid Beheshti University of Medical Sciences Evaluation of Laser Acupuncture in the treatment of Fatty liver Evaluation of Laser Acupuncture in the treatment of Fatty liver 2023-11-21 anticipated 30 Complete https://irct.ir/trial/73453 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Fatty liver disease with 2 and 3 grading. Intervention 1: Control group: In this group, only periodical tests and fiberscan are performed according to what was said. Both groups are advised to follow their diet. Intervention 2: Intervention group: The treatment procedure is performed with PLP-IR laser with a power of 300 mW and a wavelength of 810 nm with a dose of 6 joules in each point for 3 times a week and for 12 sessions for 1 month. In the case group, based on traditional Chinese medicine, common points in the treatment of fatty liver are intervened as follows: Points in the body: REN12, GB34, LIV 3-8-13-14, SP6-9, BL18-19-20- 21, ST40-ST36, Hearth 5, Hearth 8, Shenmen, and in ear points: Liv, Shenmen, Spleen and Gallbladder. The laser handle is placed vertically and directly on the point and its light is irradiated. A brief contact with the skin is made during the irradiation to avoid scattering of the irradiated light. During the light radiation, the patient does not feel any heat.Evaluations are done once before assigning patients to treatment groups, once at the end of treatment, and once in the third and sixth months after the end of treatment. Measurements before and after the treatment are done by a skilled doctor independent of the plan who is unaware of the treatment group. Laboratory and paraclinical evaluations are also performed blindly to the treatment group. The desired statistics in this project are based on several sections: 1. Consultation for fatty liver grading before and after the treatment period (fibroscan) 2. Measuring height and weight of patients and calculating BMI as a score obtained by dividing weight in kilograms by the square of height in meters3. Calculating and giving the appropriate and almost identical treatment regimen to patients based on BMI and increasing sports activity 4. By performing a fibroscan of the liver, the degree of steatosis and fibrosis of the fatty liver and its grade are determined5. Laboratory evaluations including CBC, diff and AST, ALT, ALKP, fasting blood sugar, triglyceride, total cholesterol, LDL and HDL, BUN, Cr, TSH, T4, Vit D and insulin will be measured as laboratory criteria before treatment.For the tests, the patient is asked to fast for at least 12 hours. About 10 cc of blood is received from the patient and sent as a clot to the laboratory of Tajrish Martyrs Hospital for laboratory examination. 6. In order to check the quality of life, the Short Form-36 questionnaire is used, which examines the physical and mental health of the person. The SF-36 questionnaire contains 11 questions about physical health and mental health. 7. After the end of the treatment, the above tests are repeated and the patients are again subjected to fibroscan and blood test. Fibroscan and tests are repeated three months and six months later. No - There is not a plan to make this available Justification or reason for not sharing IPD is The publication is in the form of an article and it is not necessary to provide data in the article
public Mohammad Reza Razzaghi
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8021 m-razaghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Somayeh Jahani
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8021 laser.cntr@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) In the form of a randomized blinded clinical trial, patients with fibrotic fatty liver with increased liver enzymes (AST and ALT above 40) aged 20 to 70 years who refer to Taleghani Hospital for treatment are examined in terms of inclusion criteria. The criteria for entering the study include grade 2 and 3 fatty liver with increased liver enzymes confirmed by fibroscan and age 20 to 70 years, which is full consent to participate in the study and complete the treatment and follow-up process. 20 years 70 years Both Patients with diabetes, pregnant and lactating, hyperlipidemia and hypercholesterolemia, taking any medication in the last month, hepatitis, cardiovascular patients, hypertension, hyper and hypothyroid, fibroid and polycystic ovary, hormonal disorders, age under 20 and over 50 years and receiving laser for any other reason are excluded from the study process. K76.0 Fatty (change of) liver, not elsewhere classified N/A Treatment - Devices Control group: In this group, only periodical tests and fiberscan are performed according to what was said. Both groups are advised to follow their diet. Intervention group: The treatment procedure is performed with PLP-IR laser with a power of 300 mW and a wavelength of 810 nm with a dose of 6 joules in each point for 3 times a week and for 12 sessions for 1 month. In the case group, based on traditional Chinese medicine, common points in the treatment of fatty liver are intervened as follows: Points in the body: REN12, GB34, LIV 3-8-13-14, SP6-9, BL18-19-20- 21, ST40-ST36, Hearth 5, Hearth 8, Shenmen, and in ear points: Liv, Shenmen, Spleen and Gallbladder. The laser handle is placed vertically and directly on the point and its light is irradiated. A brief contact with the skin is made during the irradiation to avoid scattering of the irradiated light. During the light radiation, the patient does not feel any heat.Evaluations are done once before assigning patients to treatment groups, once at the end of treatment, and once in the third and sixth months after the end of treatment. Measurements before and after the treatment are done by a skilled doctor independent of the plan who is unaware of the treatment group. Laboratory and paraclinical evaluations are also performed blindly to the treatment group. The desired statistics in this project are based on several sections: 1. Consultation for fatty liver grading before and after the treatment period (fibroscan) 2. Measuring height and weight of patients and calculating BMI as a score obtained by dividing weight in kilograms by the square of height in meters3. Calculating and giving the appropriate and almost identical treatment regimen to patients based on BMI and increasing sports activity 4. By performing a fibroscan of the liver, the degree of steatosis and fibrosis of the fatty liver and its grade are determined5. Laboratory evaluations including CBC, diff and AST, ALT, ALKP, fasting blood sugar, triglyceride, total cholesterol, LDL and HDL, BUN, Cr, TSH, T4, Vit D and insulin will be measured as laboratory criteria before treatment.For the tests, the patient is asked to fast for at least 12 hours. About 10 cc of blood is received from the patient and sent as a clot to the laboratory of Tajrish Martyrs Hospital for laboratory examination. 6. In order to check the quality of life, the Short Form-36 questionnaire is used, which examines the physical and mental health of the person. The SF-36 questionnaire contains 11 questions about physical health and mental health. 7. After the end of the treatment, the above tests are repeated and the patients are again subjected to fibroscan and blood test. Fibroscan and tests are repeated three months and six months later. Steatosis grading. Timepoint: Before and 1, 3, 6 months after intervention. Method of measurement: Fibrscan. Fibrosis grading. Timepoint: Before and 1, 3, 6 months after intervention. Method of measurement: Fibrscan. Biochemical profile. Timepoint: Before and 1, 3, 6 months after intervention. Method of measurement: Blood sample. Shahid Beheshti University of Medical Sciences Approved 2018-08-22 Ethics committee of Shahid Beheshti University of Medical Sciences laser application in medical sciences research center, shohada tajrish hospital tehran Tehran Iran (Islamic Republic of)