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IRCT20120415009472N27 IRCT 2023-08-30 Iran University of Medical Sciences Investigating the effect of zataria multiflora in ulcerative colitis The effect of zataria multiflora alcoholic extract on clinical symptoms, mediator genes of immunity, inflammatory and oxidative stress indices in patients with ulcerative colitis 2023-09-06 anticipated 92 Complete https://irct.ir/trial/72134 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be divided into two groups by block randomization method: intervention group and control group. The randomization list is produced by a statistician in the form of random blocks with a volume of 4 and considering 2 groups A and B (zataria multiflora and placebo). Then, during packing, randomization of the packages will be done according to the list and allocated to the patients accordingly. After conducting experiments and completing the study, a random list will be given to the researcher and analysis will be done. Until the end of the data analysis, the patient and the analyst will not be informed about the type of drug and placebo, and this issue will remain confidential. In case of deviation from the protocol, the analysis method will be used with the intention of treatment, Blinding description: Considering that this study is double-blind in the sense that the researcher, the patient and the analyst do not know what type of dietary supplement is being taken (Zataria Multiflora supplement or placebo). To accomplish this task, the extract and placebo are packaged in similar bottles with the same information and instructions, and coded as A and B by someone other than the interventionist, so the interventionist is unaware of the capsule type. The values ​​obtained from each group should be noted. N/A Patients with ulcerative colitis. Intervention 1: Intervention group: Patients will receive 6 mg per kilogram of body weight per day of zataria multiflora extract for a period of 2 months along with food in three times after breakfast, lunch and dinner, which are provided by "Giah Essence Phitopharm Co.". Intervention 2: Control group: Patients will receive 6 mg per kilogram of body weight per day of placebo for 2 months with food in three times after breakfast, lunch and dinner, which is prepared in the pharmacology laboratory of Ahvaz University of Medical Sciences. Yes - There is a plan to make this available What will be shared: Unidentifiable personal data of participants; Only part of the data such as the original outcome information When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions Where to obtain: n-aryaeian@sina.tums.ac.ir, morvaridi.m@iums.ac.ir How to obtain: Document request email, applicant review, after confirmation, documents will be provided to the applicant. Comments:
public Dr. Nahid Aryaeian
Faculty of Health, Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences scientific Dr. Nahid Aryaeian
Faculty of Health, Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Body mass index 18.5 to 35 kg/m2 Diagnosing ulcerative colitis by a gastroenterologist based on the Rome III Diagnostic Criteria for functional digestive disorders (flatulence, constipation and diarrhea), the Mayo score system, colonoscopy and laboratory findings Disease duration more than 6 months and less than 5 years 18 years 65 years Both Patients with the acute phase of the disease Suffering from autoimmune diseases and other inflammatory diseases (renal, cardiovascular, liver diseases, types of cancer and acquired immunodeficiency syndrome (HIV)) Thyroid disorders History of gastrointestinal surgeries Diabetes Mellitus Pregnancy and lactation History of allergy to zataria multiflora Treatment - Drugs Placebo Intervention group: Patients will receive 6 mg per kilogram of body weight per day of zataria multiflora extract for a period of 2 months along with food in three times after breakfast, lunch and dinner, which are provided by "Giah Essence Phitopharm Co.". Control group: Patients will receive 6 mg per kilogram of body weight per day of placebo for 2 months with food in three times after breakfast, lunch and dinner, which is prepared in the pharmacology laboratory of Ahvaz University of Medical Sciences. High-Sensitivity C-Reactive Protein (hs-CRP). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: It is measured by colorimetric method and by autoanalyzer. enzyme-linked immunosorbent assay(ELISA). Erythrocyte sedimentation rate(ESR). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Vacuum tube erythrocyte sedimentation rate. Interferon gamma (IFN-γ). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: It is measured by colorimetric method and by autoanalyzer. enzyme-linked immunosorbent assay(ELISA). Interleukin 17 (IL17). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: It is measured by colorimetric method and by autoanalyzer. enzyme-linked immunosorbent assay(ELISA). Total antioxidant capacity (TAC). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Chromatography. Malondialdehyde (MDA). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Spectrophotometry. Nuclear factor kappa light chain enhancer of activated B cells (NF-κB). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Real time PCR. T-box transcription factor (T-bet). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Real time PCR. GATA Binding Protein 3 (GATA3). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Real time PCR. Forkhead box P3 (FOXP3). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Real time PCR. RAR-related orphan receptor gamma (RORγt). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Real time PCR. Body Mass Index(BMI). Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: Weight in kg per square meter in height in meters. Waist circumference. Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: The shortest distance around the waist, below the chest and above the navel. Intensity of physical activity. Timepoint: Measurements at the beginning of the study (before the intervention) and 2 months after taking zataria multiflora supplement. Method of measurement: The amount of physical activity of individuals during the last 7 days in terms of metabolic equivalent. Iran University of Medical Sciences Approved 2023-06-13 Ethics committee of Iran University of Medical Sciences Research and Technology Vice-Chancellor, Central Headquarters Building, Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran Tehran Tehran Iran (Islamic Republic of)