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IRCT20221216056833N1 IRCT 2023-02-15 Kerman University of Medical Sciences The effect of Noshin Shahd herbal syrup on liver function of patients with alcoholic fatty liver disease Noshin NAFLD Evaluation of the efficacy of Noushin-Shahd-herbal-syrup on markers of liver function, inflammation and oxidative stress in patients with non-alcoholic fatty liver disease; a double blind randomized clinical trial study 2023-04-21 anticipated 60 Complete https://irct.ir/trial/67452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: It reminds us that the extract of ten plants effective in the treatment of fatty liver disease, produced by Nursing Shahdarumieh company, is mass produced with health license number 12.14310 since 2018. This product contains the effective ingredients of common safe medicinal plants that are effective in the treatment of fatty liver disease. It should be noted that during the 4 years of providing the product to the applicants, while declaring the satisfaction of the customers with the performance of the product, no toxicity or complaints have been reported from the people consuming the extract of ten plants, Randomization description: The randomization process will be according to the stratified randomization method. Stratification of patients will be performed based on age, gender, and BMI, With the help of Winpepi software (V 11.6), Blinding description: The patient receives the drug or placebo in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the medicine, evaluator, and patient will be blinded. 4 Non-alcoholic fatty liver disease. Intervention 1: All the volunteers who meet the entry criteria were directed to the laboratory and imaging center so that biochemical tests and liver fibroscans can be performed on them before taking the drug. Volunteers are asked to take the received medicine twice a day after food. It is worth mentioning that the patients will be divided into two groups by a person outside the research team, one group will drink herbal syrup and the other group will receive a placebo. A placebo with the same appearance as herbal syrup will drink nectar. On a weekly basis, the researcher will make phone calls with the applicants and, while reminding and recording the amount of herbal syrup consumed by drinking nectar, will also ask about the possible side effects of consuming herbal syrup drinking nectar. Then, at the end of the eighth week, the patient was asked to visit the clinic for a final evaluation. In this stage, the patient is asked about possible side effects, and the last stage of sample collection will be done to review all the tests of the next stage of receiving the drug (biochemical tests and liver fibroscan). Return at the end of week 8. Intervention 2: It is worth mentioning that the placebo with the same appearance as the herbal syrup will be drinking nectar. On a weekly basis, the researcher can contact the applicants by phone and while reminding them to use the placebo, they will also be informed about the possible side effects of its use. Biochemical tests and liver fibroscans will be performed on them before taking the placebo. The volunteers were asked to take the received placebo twice a day after meals. Then, at the end of the eighth week, the patient was asked to visit the clinic for a final evaluation. At this stage, the patient will be asked about possible side effects, and the last stage of sample collection will be done to review all the tests for the next stage of receiving theplacebo (biochemical tests and liver fibroscan). Yes - There is a plan to make this available What will be shared: A part of the data such as the information related to the main outcome or the like can be shared. When: Access to study documentation after results are published To whom: It will be available for researchers working in academic and scientific institutions, and also people who are working in the industry can apply for them. Conditions: For secondary studies Where to obtain: The herbal and traditional medicines Research Center of Kerman University of Medical Sciences. How to obtain: The request sent will be reviewed by the members of the center. If the members agree, they will be notified. Comments: There is no further information.
public Hossein Pourghadamyari
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7448 ghadamyarih91@gmail.com Kerman University of Medical Sciences scientific Hossein Pourghadamyari
Kerman University of Medical Sciences, Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7448 ghadamyarih91@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 30 and 65 years Consistency of exercise program Body mass index less than 40 Not having a specific disease Not drinking alcohol 30 years 65 years Both Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year Taking anti-inflammatory drugs such as aspirin with an anti-inflammatory dose, antioxidant supplements, vitamins and omega-3 capsules (<1 g/day), and immunosuppressive drugs in the last three months Presence of cancer, liver and thyroid diseases pregnancy alcohol consumption Taking drugs that lower blood cholesterol and triglycerides K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo All the volunteers who meet the entry criteria were directed to the laboratory and imaging center so that biochemical tests and liver fibroscans can be performed on them before taking the drug. Volunteers are asked to take the received medicine twice a day after food. It is worth mentioning that the patients will be divided into two groups by a person outside the research team, one group will drink herbal syrup and the other group will receive a placebo. A placebo with the same appearance as herbal syrup will drink nectar. On a weekly basis, the researcher will make phone calls with the applicants and, while reminding and recording the amount of herbal syrup consumed by drinking nectar, will also ask about the possible side effects of consuming herbal syrup drinking nectar. Then, at the end of the eighth week, the patient was asked to visit the clinic for a final evaluation. In this stage, the patient is asked about possible side effects, and the last stage of sample collection will be done to review all the tests of the next stage of receiving the drug (biochemical tests and liver fibroscan). Return at the end of week 8. It is worth mentioning that the placebo with the same appearance as the herbal syrup will be drinking nectar. On a weekly basis, the researcher can contact the applicants by phone and while reminding them to use the placebo, they will also be informed about the possible side effects of its use. Biochemical tests and liver fibroscans will be performed on them before taking the placebo. The volunteers were asked to take the received placebo twice a day after meals. Then, at the end of the eighth week, the patient was asked to visit the clinic for a final evaluation. At this stage, the patient will be asked about possible side effects, and the last stage of sample collection will be done to review all the tests for the next stage of receiving theplacebo (biochemical tests and liver fibroscan). Liver steatosis level. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: Fibroscan. Serum levels of ALT. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: Biochemical Autoanalyzor. Kerman University of Medical Sciences Approved 2023-02-06 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)