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IRCT20140824018915N7 IRCT 2018-05-21 Mashhad University of Medical Sciences Evaluation of the effect of egg lotion on treatment of solitary rectal ulcer Effect of egg lotion on treatment of SRU 2018-02-12 anticipated 60 Complete https://irct.ir/trial/30750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple randomization method is that envelopes containing drugs are provided and numbered by an individual outside the study based on a random allocation table. Then these envelopes are handed to patients in turn, Blinding description: This is a double-blinded study in which researcher and patient are unaware of the type of intervention which means researcher and patient have no knowledge of the content of the envelope and treatment method. 2-3 Solitary rectal ulcer syndrome. Intervention 1: Intervention group: In addition to sucralfate enema, anti solitary rectal ulcer egg lotion is prescribed. Intervention 2: Control group: sucralfate enema is prescribed. Yes - There is a plan to make this available What will be shared: In case organizations ask for the data of participants, the data will become accessible for them. When: The data can be accessible for specific organization request 6 month after the article is published. To whom: All academic institutes and non-academic industrial institutes which are related to our studies will have access to our data after going through legal procedures. Conditions: In case those people asking for data have the intention of optimizing the study an data and producing more results, access to data is allowed. Where to obtain: Through sending an email to the corresponding author, data will be obtainable. How to obtain: In case someone asks for data, he must first get in contact with the corresponding author for his identity to be fully verified. Then if university allows propagation of data, it will be accessible in 3 months. Comments:
public Fatemeh Dadellahi
Ahmad Abad Ave, Ghaem hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2742 Dadelahif901@mums.ac.ir Mashhad University of Medical Sciences scientific Mousalreza Hoseini
Ahmad Abad Ave, Ghaem hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2742 hoseinimr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with rectology who are confirmed to have solitary rectal ulcer throught recto-sigmoidoscopy no limit no limit Both K62.6 Ulcer of anus and rectum Treatment - Drugs Treatment - Drugs Intervention group: In addition to sucralfate enema, anti solitary rectal ulcer egg lotion is prescribed. Control group: sucralfate enema is prescribed. Rate of improvement of solitary rectal ulcer. Timepoint: Patients are under treatment for 7 days. They are examined every two days during treatment period. After completing the course of treatment, patients are followed up monthly for three months. After the three month period, recto-sigmoidoscopy is carried out. Method of measurement: use of recto-sigmoidoscopy for confirmation or rejection of complete improvement of the SRU. Rate of hemorrhage improvement. Timepoint: Patients are under treatment for 7 days. They are examined every two days during treatment period. After completing the course of treatment, patients are followed up monthly for three months. After the three month period, recto-sigmoidoscopy is carried out. Method of measurement: Clinical examination and recto-sigmoidoscopy. Mashhad University of Medical Sciences Approved 2017-12-13 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)