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IRCT20190415043279N10 IRCT 2021-03-05 Sanandaj University of Medical Sciences Effect of Trachyspermum ammi in the reduction of bleeding in patients with IBD Effect of Ethanolic extract of Trachyspermum ammi as adjuvant in the reduction of bleeding in patients with IBD 2021-02-19 anticipated 64 Complete https://irct.ir/trial/52956 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For apply randomization, the permuted block randomization will be used with quadruple blocks. Blocks will be produced by using the online site (www.sealedenvelope.com). Using block randomization method and online statistical software (www.sealedenvelope.com), 64 patients will be divided into two equal groups of intervention and control in 8 blocks of 4. To hide random sequences, the sealed envelope method is used. First, a random sequence is created by one of the mentioned methods. then based on the sample size a number of envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) are prepared and each of the random sequences created is recorded on a card. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed, Blinding description: All supplements and placebo capsules will be identical with respect to appearance and will differ only in the encoding of the capsules. The treatment code of the intervention supplements will be blind for subjects, investigators and staff involved in the conduct of the study. 3 Ulcerative colitis. Intervention 1: Intervention group: Capsule containing Ethanolic extract of Trachyspermum ammi at two dose of 250 mg per day for three consecutive months. These oral capsules of Ethanolic extract of Trachyspermum ammi will be prepared by a reputable pharmacist. Intervention 2: Control group: Placebo in capsules at two dose of 250 mg per day for three consecutive months. These placebo oral capsules contain starch and will be prepared by a reputable pharmacist. 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 There is no more information
public Dr Farshad Sheikhesmaeili
Tohid Hospital, Tohid Blvd
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4645 dr_s_smaili@yahoo.com Sanandaj University of Medical Sciences scientific Dr Farshad Sheikhesmaeili
Tohid Hospital, Tohid Blvd
Sanandaj Iran (Islamic Republic of) 6616813131 +98 87 3328 6112 dr_s_smaili@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age 18 to 75 years Patients diagnosed with Ulcerative colitis by a gastroenterologist 18 years 75 years Both Crohn's disease Pregnancy Breastfeeding History of allergy to herbal medicines K51 Ulcerative colitis Placebo Placebo Intervention group: Capsule containing Ethanolic extract of Trachyspermum ammi at two dose of 250 mg per day for three consecutive months. These oral capsules of Ethanolic extract of Trachyspermum ammi will be prepared by a reputable pharmacist. Control group: Placebo in capsules at two dose of 250 mg per day for three consecutive months. These placebo oral capsules contain starch and will be prepared by a reputable pharmacist. Number of daily bowel movements. Timepoint: Beginning and end of the intervention. Method of measurement: Disease Activity Questionnaire. Daily rectal bleeding. Timepoint: Beginning and end of the intervention. Method of measurement: Disease Activity Questionnaire. Classification of bleeding according to symptoms and tests by a physician. Timepoint: Beginning and end of the intervention. Method of measurement: Disease Activity Questionnaire. Fecal occult blood. Timepoint: Beginning and end of the intervention. Method of measurement: Stool test. Blood Hemoglobin. Timepoint: Beginning and end of the intervention. Method of measurement: CBC test. C-Reactive Protein. Timepoint: Beginning and end of the intervention. Method of measurement: Agglutination method. Erythrocyte sedimentation rate (ESR). Timepoint: Beginning and end of the intervention. Method of measurement: ESR device. Sanandaj University of Medical Sciences Approved 2020-09-08 Ethics committee of Kurdistan University of Medical Sciences Pasdaran Blvd., Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)