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IRCT20200406046965N2 IRCT 2021-09-20 Mashhad University of Medical Sciences Evaluation of the effect of Thymus kotschyanus Boiss. & Hohen. in improving ulcerative colitis symptoms Evaluation of the effect of Thymus kotschyanus Boiss. & Hohen. in improving ulcerative colitis symptoms 2021-09-23 anticipated 30 Complete https://irct.ir/trial/58667 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random sequence generation: a computer software was performed and randomization sequence was used to receive active herbal remedy or placebo. This sequence contained two letters : A for Thymus kotschyanus and B for placebo. Allocation concealment: a person except the executer, stick the letter A and B on the capsule boxes based on computer software randomization. Execution of random allocation process: B:A person who evaluates and registers researchers in terms of inclusion and exclusion criteria. A:The person who has assigned the participants to the groups: Gastroenterologists, does not interfere in other stages of randomization, including registration and allocation of participants, Blinding description: The treatment drug and placebo are given as same-colored and same-sized capsule with containers in boxes labeled with the letters A and B. The medical staff, the patient and the data collector are unaware of the nature of the drug or placebo and of the content of the boxes. The executor of this research project is the only person aware of the contents of boxes. 2 ulcerative colitis. Intervention 1: Intervention group: consisted of 15 patients who were randomized by computer took one extraction capsule three times a day by the effective daily dose 0.5 grams of T. kotschyanus beside the standard colitis treatment regimen. These patients administered the extraction capsule for 3 months by the total dose of 45 grams of the extraction in the whole time of trial. The capsules will be prepared at the School of Pharmacy, Mashhad University of Medical Sciences. Intervention 2: Control group: 15 patients who were randomized by computer took one placebo capsule three times a day for 3 months beside the standard colitis treatment regimen. The placebo capsules ill be prepared at the School of Pharmacy, Mashhad University of Medical Sciences. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to a recent decision by Mashhad University of Medical Sciences Research Council, the raw data and results of any clinical trial regarding colitis disease should be confirmed by this council before publication.
public Seyed Ahmad Emami
School of Pharmacy, University Campus, VakilAbad boulvard
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1267 emamia@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Ahmad Emami
School of Pharmacy, University Campus, VakilAbad boulvard
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1267 emamia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients who were diagnosed by ulcerative colitis and not been hospitalized during this clinical trial Patients must be between 13 and 65 years' old The Simple Clinical Colitis Activity Index (SCCAI) score must be higher than 5 and less than 13 Patients must have taken mesalazine with fixed dose since at least 1 month ago and not exceed more than 4.5 grams mesalazine in a day If patients have administered topical mesalazine it should be used at least for 2 weeks with a fixed dose and not exceed more than 4 grams in a day Patients shouldn’t have taken another anti-inflammatory or immunomodulatory medicine except mesalazine Hemoglobin must be higher than 10 No concurrent disease such as diabetes, cardiovascular disease, kidney disease, liver disease, thyroid disease, bile disease No concurrent leukopenia, thrombocytopenia or other blood coagulation disorders No concurrent sepsis or any active infection No pregnancy or breast feeding No taking any anti-coagulant medicine No history for epilepsy or convulsions 13 years 65 years Both Acute severe ulcerative colitis requiring hospital admission (SCCAI >13); inactive disease (SCCAI < 3). A history of sensitivity to Thymus kotschyanus or its preparations. A history of diabetes, cardiovascular diseases, kidney disease, liver diseases, thyroid disease, bile disease and leukopenia, thrombocytopenia. Hemoglobin less than 10. Pregnancy. Reluctance to continue this trial. K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: consisted of 15 patients who were randomized by computer took one extraction capsule three times a day by the effective daily dose 0.5 grams of T. kotschyanus beside the standard colitis treatment regimen. These patients administered the extraction capsule for 3 months by the total dose of 45 grams of the extraction in the whole time of trial. The capsules will be prepared at the School of Pharmacy, Mashhad University of Medical Sciences. Control group: 15 patients who were randomized by computer took one placebo capsule three times a day for 3 months beside the standard colitis treatment regimen. The placebo capsules ill be prepared at the School of Pharmacy, Mashhad University of Medical Sciences. Reduction in SCCAI score. Timepoint: 12 weeks after intervention beginning. Method of measurement: Filling the questionnaire for SCCAI score . Reduction in calprotectin protein. Timepoint: 12 weeks after intervention beginning. Method of measurement: Measuring the laboratory test for fecal calprotectin. Remission and improvement changes in SIBDQ scores. Timepoint: 12 weeks after intervention beginning. Method of measurement: Filling the SIBDQ questionnaire. Reduction in SEO index. Timepoint: 12 weeks after intervention beginning. Method of measurement: Measuring the related laboratory test for SEO index. Finding T. kotschyanus possible adverse effects. Timepoint: Week 4 and 8 and 12 after intervention beginning. Method of measurement: Asking patients about any adverse reaction incidence. Mashhad University of Medical Sciences Approved 2020-04-13 Medical Ethics Committee of Mashhad University of Medical SciencesMedical Ethics Committee of Mashha School of Pharmacy, University Campus, Vakil Abad boulvard Mashhad Razavi Khorasan Iran (Islamic Republic of)