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IRCT20140824018915N6 IRCT 2018-04-27 Mashhad University of Medical Sciences Investigation of the effect of Samen-ista emulsion on the treatment of upper gastrointestinal non-bleeding visible vessel Investigation of the effect of Samen-ista emulsion on the treatment of upper gastrointestinal non-bleeding visible vessel in comparison with the effect of adrenaline injection with Argon plasma coagulation or clips 2018-01-05 anticipated 90 Complete https://irct.ir/trial/29284 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done through a randomization table provided by a computer. In order to conceal the randomized allocation of groups, sealed and numbered envelopes will be used. When a patient refers, envelopes are opened in turn and the treatment methods will be determined, Blinding description: This is a single-blinded study in which participants are not aware of their treatment method. Based on the sealed envelopes, type of treatment is determined in the time endoscopy. 3 Diseases of esophagus, stomach and duodenum. Intervention 1: Intervention group: If there is a non-bleeding visible vessel in endoscopy, lavage with Samen-ista emulsion (a combination of minerals and herbals made by Simorgh Attar company) is done in the ulcer location once. Intervention 2: Control group: If there is a non-bleeding visible vessel in endoscopy, ulcer treatment will be done through adrenaline injection and Argon plasma coagulation. Intervention 3: Control group: If there is a non-bleeding visible vessel in endoscopy, ulcer treatment will be done through adrenaline injection and clips. 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 Amir Abbas Hasanzadeh
Emam Reza Sq, Ebne-Sina Ave, Emam Reza hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3801 2769 HasanzadehA951@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 upper gastrointestinal bleeding who refer to the emergency wards of Ghaem and Imam Reza hospitals with non-bleeding visible vessel during initial endoscopy 18 years 70 years Both All types of bleeding except bleedings caused by a non-bleeding visible vessel Pregnancy Hemodynamic instability during endoscopy Uncorrected coagulation disorders Peptic ulcers that have undergone endoscopic treatment within the last 7 days Thrombocytopenia less than 100,000 Kidney Failure (Creatinine> 1.5) K25.0 Acute gastric ulcer with hemorrhage Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: If there is a non-bleeding visible vessel in endoscopy, lavage with Samen-ista emulsion (a combination of minerals and herbals made by Simorgh Attar company) is done in the ulcer location once. Control group: If there is a non-bleeding visible vessel in endoscopy, ulcer treatment will be done through adrenaline injection and Argon plasma coagulation Control group: If there is a non-bleeding visible vessel in endoscopy, ulcer treatment will be done through adrenaline injection and clips Rate of complications (rebleeding). Timepoint: In the first 24 hours, patient will be placed under precise monitoring (checking vital signs investigation of rebleeding) every 4 hours and then, for investigation of ulcer, another endoscopy is performed. follow ups will be done after 72 hours in the hospital and through phone calls after a month. Method of measurement: Endoscopy. Mashhad University of Medical Sciences Approved 2018-01-03 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)