]>
IRCT20201204049599N5 IRCT 2021-06-14 Oroumia University of Medical Sciences Assessment of peppermint extract effect on colonoscopy quality Assessment of peppermint extract effect on colonoscopy quality in patients referring to Urmia Imam Khomeini hospital 2021-07-26 anticipated 128 Complete https://irct.ir/trial/56033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Randomization will be performed in a simple randomization method by using a table of random numbers. Each patient will first be assigned a three-digit code. The first patient will have code 001 and the last patient will have code 128. A number will then be selected randomly. The first three digits will be examined. It will be continued from top to bottom in the table to complete the sample size. If the number is less than or equal to 128, that number will be selected. The duplicate number will be ignored and another number from the table will be checked. Numbers between 001 and 064 will be assigned to the intervention group and numbers between 065 and 128 will be assigned to the placebo group, Blinding description: The study will be double-blind. The patient and the endoscopist will be blind that which groups each patient belongs to. Peppermint extract and placebo will be the same in volume and color. Due to the smell of peppermint extract, in order the endoscopist not be noticed the placebo and the peppermint, before starting the endoscopy, some peppermint extract will be sprayed into the endoscopy room to smell only peppermint extract. 3 Colonoscopy. Intervention 1: Intervention group: 50 cc of peppermint extract in various areas of the colon during colonoscopy will be injected into the large intestine through the working channel of the colonoscope. Intervention 2: Control group: 50 cc of drinking water will be injected into the large intestine through the working channel of the Colonoscopy device in different areas of the large intestine during colonoscopy. 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 I do not have any knowledge about the result of the research
public Mohammad Reza Pashaei
Imam Khomeini Hospital, Ershad Blvd., Urmia, Iran
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 pashaee.m@umsu.ac.ir Oroumia University of Medical Sciences scientific Mohammad Reza Pashaei
Imam Khomeini Hospital, Ershad Blvd., Urmia, Iran
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 pashaee.m@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Aged 18 to 65 years, not consuming antispasmodics, suspicion of intestinal polyps, large bowel diseases, unknown origin gastrointestinal bleeding 18 years 65 years Both Irritable Bowel Syndrome, lack of having mental health and full consciousness, consumption of anti-anxiety and painkillers, having a history of allergy to any drug Treatment - Other Treatment - Other Intervention group: 50 cc of peppermint extract in various areas of the colon during colonoscopy will be injected into the large intestine through the working channel of the colonoscope. Control group: 50 cc of drinking water will be injected into the large intestine through the working channel of the Colonoscopy device in different areas of the large intestine during colonoscopy. Total time of the procedure. Timepoint: During Colonoscopy. Method of measurement: Minute. Pain. Timepoint: During Colonoscopy procedure. Method of measurement: Score based on visual analog scale (VAS). Time to reach Cecum. Timepoint: During colonoscopy. Method of measurement: Minute. Oroumia University of Medical Sciences Approved 2020-02-19 Ethics Committee of Urmia University of Medical Sciences Resalat Ave., University of Medical Sciences, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)