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IRCT20211116053073N1 IRCT 2021-12-01 Mashhad University of Medical Sciences Effect of Complementary Therapy with Purslane in Nonalcoholic Fatty Liver Disease Effect of Complementary Therapy with Hydro-Ethanolic Extract of Aerial Parts of Purslane on Clinical and Paraclinical Findings in Patients with Nonalcoholic Fatty Liver Disease 2021-12-24 anticipated 27 Complete https://irct.ir/trial/60155 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the Two Intervention and Control Groups, the Volume of each Block will be Four. Then Write A List of Blocks and Assign Numbers to them. For example (AABB (1)-ABAB (2)-ABBA (3)-BBAA (4)-BABA (5)-BAAB (6) which According to the Sample Size 27 The Number of People in each Group will be 9 blocks, then the Random Nnumbers between one and 9 will be Selected According to the Randomization Site Randomaize.com, and Finally the List of Treatment Allocation Based on Random Numbers will be Written on the Envelopes Containing each Block. Randomization type: Blocked How to make 4 blocks: We use letters depending on how many groups are studied For two groups of which 6 modes of movement are possible. A, B According to the formula, if there are two groups, a four-letter block for two letters and Formula 1 are used. 1. 4! (1 * 2 * 3 * 4) / [2! (1 * 2)] * [4-2]! = 3 * 4/2 = 6 states Allocation Concealment allocation method: Use of opaque SNOSE sealed envelopes (sequentially numbered, opaque, sealed envelopes) In this way, the envelopes will be prepared and printed by one of the team members and random numbers and will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope, Blinding description: Due to the use of placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. With the exception of the pharmacist, none of the participants, researchers, or analysts will be aware of the drug or placebo until the end of the study. In this way, the groups are identified only by codes A and B. The drugs are prepared in the same packaging and in the same form and are packaged by a person in a pharmaceutical company that is out of research in the form of A and B coding packages. The code password is stored securely in the system so that the codes can be unlocked after data collection. 3 non alcoholic fatty liver- hepatic steatosis and fibrosis-hydro-ethanolic extract of aerial parts of Purslane. Intervention 1: Intervention group: in addition to lifestyle interventions (diet therapy + physical activity), supplementation of hydro-ethanolic extract of aerial parts of Purslane with a dose of 700mg is performed for 8 weeks. Each capsule containing 350 mg of hydro-ethanolic extract of aerial parts of Purslane is given daily with two main meals (breakfast and dinner) for 8 weeks. Intervention 2: Control group: in addition to lifestyle interventions (diet + physical activity), patients received two capsules containing 350mg placebo every day for 8 weeks with the same characteristics in terms of shape, smell, color, etc., along with two main meals (breakfast and Dinner) for 8 weeks. Yes - There is a plan to make this available What will be shared: I will inform at the end of the study. When: I will inform at the end of the study. To whom: I will inform at the end of the study. Conditions: I will inform at the end of the study. Where to obtain: I will inform at the end of the study. How to obtain: I will inform at the end of the study. Comments:
public Narges Milkarizi
Mashhad University of Medical Science,Azadi Square, Mashhad City, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 Milkarizin991@mums.ac.ir Mashhad University of Medical Sciences scientific Narges Milkarizi
Mashhad University of Medical Science,Azadi Square, Mashhad City, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 Milkarizin991@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Detection of Hepatic Steatosis by Two-Dimensional Elastography Device Consent to Enter the Scheme Fatty Liver Patients with Grade F0 and F1 18 years 65 years Both Pregnancy and Lactation Diseases such as: Diabetes, Autoimmune Disorders, Cancer, Liver Failure, Viral Hepatitis History, Liver Surgery and Renal Impairment (GFR <50) History of Food Allergy to Purslane and Herbal Supplements Taking Hepatoxic Drugs such as Amiodarone, Sodium Valproate or Methotrexate Body Mass Index more than 40 Consumption of Alcohol more than 30 grams per day for Men and also Consumption of more than 20 grams per day for Women History of Bariatric Surgery Fatty Liver Patients with F2, F3, F4 Grades Consumption of any Multivitamin Supplement and Antioxidant Compounds such as Vitamins C, E and Herbal Medicines during the Intervention Period K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: in addition to lifestyle interventions (diet therapy + physical activity), supplementation of hydro-ethanolic extract of aerial parts of Purslane with a dose of 700mg is performed for 8 weeks. Each capsule containing 350 mg of hydro-ethanolic extract of aerial parts of Purslane is given daily with two main meals (breakfast and dinner) for 8 weeks. Control group: in addition to lifestyle interventions (diet + physical activity), patients received two capsules containing 350mg placebo every day for 8 weeks with the same characteristics in terms of shape, smell, color, etc., along with two main meals (breakfast and Dinner) for 8 weeks. Hepatic steatosis and fibrosis. Timepoint: before and at the end of the study. Method of measurement: Two-dimensional elastography device. Measurement of anthropometric indices. Timepoint: Before, in the middle and at the end of the study. Method of measurement: Scales, meters,. Measurement of body composition by BIA device. Timepoint: Before, in the middle and at the end of the study. Method of measurement: BIA. Measurement of serum concentrations of oxidative stress indicators including malondialdehyde, glutathione. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Evaluation of IPAQ physical activity questionnaire and three-day food recall. Timepoint: Before, in the middle and at the end of the study. Method of measurement: statistical methods. Measurement of serum concentrations of lipid profiles including TC, HDL-C, LDL-C and TG. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Measurement of serum concentrations of fasting blood glucose and insulin. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Measurement of serum concentrations of hepatic profiles including ALT, ALP ,AST,GGT. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Measurement of serum concentrations of inflammatory markers including ESR and Hs-CRP. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Mashhad University of Medical Sciences Approved 2021-10-31 Ethics committee of Mashhad university of medical science Nutrition department, Faculty of medicine Mashhad University of Medical Sciences (MUMS), Azadi square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)