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IRCT201410062709N30 IRCT 2014-11-15 Vice chancellor for research, Iran University of Medical Sciences The effect of nettle extract in patients with inflammatory bowel Disease The effect of urtica dioica leaf extract on tumor necrosis factor alpha, high- sensitivity C- reactive protein, superoxide dismutase, erythrocyte sedimentation rate, blood cell count, calprotectin and quality of life in patient with inflammatory bowel disease compared with the control group that received placebo 2014-11-01 anticipated 64 Complete https://irct.ir/trial/2542 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is done by stratified blocked randomization. Placebo in the form of a double-blind to the participants in this study given. Researchers and patients are blinded to the treatment and placebo groups. 2 Inflammatory bowel disease. Intervention 1: Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group. Intervention 2: Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.
public Doctor Farzad Shidfar
Faculty of Health, Iran University of Medical Sciences, near milad Hospital, Shahid Hemmat Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 8862 2706 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Doctor Farzad Shidfar
Faculty of Health, Iran University of Medical Sciences, near milad Hospital, Shahid Hemmat Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 8862 2706 Shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Willingness to participate in the study, inflammatory bowel disease in mild and moderate stages, no change in the type and dose of medication during the study, without any other diseases such as intestinal diseases, known autoimmune diseases, cancer, inflammatory diseases, infectious diseases, non-pregnant or breastfeeding women or non-use of contraceptive pill, not Having edema caused by heart or renal disease, no use of dietary supplements and herbal pills, no use of anticoagulant drugs such as heparin and antibiotics, patients in the study use similar types of drugs. Exclusion criteria: The patient's unwillingness to cooperate, exacerbation of disease resulting in hospitalization, changes in dosage and type of medication during intervention, sensitivity to nettle, compliance rate of less than 90%. no limit no limit Both K50, K51 Crohn disease of small intestine, Ulcerative colitis Treatment - Drugs Placebo Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group. Erythrocyte Sedimentation Rate. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Automation Method (mm/h). High- sensitivity C- reactive protein. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is mg/dl. Quality of life. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form. White blood cell. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/ml). Superoxide dismutase. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml. Platelet. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/µl). Fecal calprotectin. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is µg/g. Tumor necrosis factor alpha. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml. Vice chancellor for research, Iran University of Medical Sciences Approved 2014-10-27 Ethics committee of Iran University of Medical Sciences Faculty of Health, Iran University of Medical Sciences, near milad Hospital, Shahid Hemmat Highway, Tehran, Iran Tehran Iran (Islamic Republic of)