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IRCT20160709028845N1 IRCT 2022-03-07 Ahvaz University of Medical Sciences The effect of black seed on irritable bowel syndrome Evaluation of total black seed (nigella sativa) extract efficacy in patients with irritable bowel syndrome 2022-02-20 anticipated 160 Complete https://irct.ir/trial/61056 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is block randomization with block with sizes of two, four and six. We will use https://www.sealedenvelope.com for generating random sequences. This software will generate control and comparator groups and will generate unique codes for every participant. Participants will enroll according to the order of their entrance into the study. They will receive an opaque envelope that the unique code is on it and medicine is in it (concealment), Blinding description: Study participants as patients in the two study groups, researchers and physicians under their supervision. are kept blind.For blinding patients, the drug and placebo are provided to patients in similar containers, which are only mentioned in the title of the research project and serial number. At the end of the study, the serial is converted to groups A and B in Excel software. Statistical analysis then determines which group of drugs or placebo. 2-3 irritable bowel syndrome. Intervention 1: Intervention group: Patients with irritable bowel syndrome are taking 500 mg of black seed extract capsules every 12 hours during the study. Extraction and preparation of capsules is performed under the supervision of a pharmacist in Ahvaz Jundishapur School of Medical Sciences. The process of receiving black seed capsules is up to three months. Intervention 2: Control group: Patients with irritable bowel syndrome who take starch capsules as a placebo every 12 hours during the study. Extraction and preparation of capsules is done under the supervision of a refereeing specialist in Ahvaz Jundishapur School of Medical Sciences. The process of receiving black seed capsules is up to three months. Yes - There is a plan to make this available What will be shared: All data in the form of typed files and the names of distorted patients are presented north of the questionnaires. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: After obtaining a permission from the Vice Chancellor for Research of Ahvaz University Where to obtain: Vice Chancellor for Research of Ahvaz University How to obtain: By sending an email and a complete introduction and the reason for the need to receive information, if the request for documents is appropriate, it will be sent via email. Comments:
public Nima Bakhtiarri
No 4, 4th east street, Kianpars, Ahvaz
Ahvaz Iran (Islamic Republic of) 6122334678 +98 61 3392 9324 bakhtiari.n@ajums.ac.ir Ahvaz University of Medical Sciences scientific Nima Bakhtiarri
No 4, 4th east street, Kianpars, Ahvaz
Ahvaz Iran (Islamic Republic of) 6133224678 +98 61 3392 9324 bakhtiari.n@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Irritable Bowel Syndrome Based on Roma IV Diagnosis Criteria. People aged 18 to 50 years and if they are over 50 years old, colonoscopy should be screened to make sure there are no other diseases and malignancies. No malignancies (carcinoid and colorectal tumors), celiac disease, diverticulitis, gastrointestinal infections, hyper and hypothyroidism, lactose intolerance, IBD, and ischemic colitis No previous use of drugs, calcium channel blockers and antidepressants 18 years 50 years Both Having a history of allergy to black seed compounds Dissatisfaction with attending the study Pregnancy K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: Patients with irritable bowel syndrome are taking 500 mg of black seed extract capsules every 12 hours during the study. Extraction and preparation of capsules is performed under the supervision of a pharmacist in Ahvaz Jundishapur School of Medical Sciences. The process of receiving black seed capsules is up to three months. Control group: Patients with irritable bowel syndrome who take starch capsules as a placebo every 12 hours during the study. Extraction and preparation of capsules is done under the supervision of a refereeing specialist in Ahvaz Jundishapur School of Medical Sciences. The process of receiving black seed capsules is up to three months. Severity of abdominal pain,. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale. Severity of abdominal distension. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale. Satisfaction with defecation habit. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale. Quality of life in patients with irritable bowel syndrome. Timepoint: At the beginning of the study and every month for three consecutive months. Method of measurement: world health organization quality of life questioner (brief form). Ahvaz University of Medical Sciences Approved 2022-01-09 Ethics committee of Ahvaz Jondishapur University of Medical Sciences Azadegan St. (24 meters) Imam Khomeini Educational and Medical Center Ahwaz Khouzestan Iran (Islamic Republic of)