The effect of Samen-ista emulsion on treatment of bleeding from benign ulcers of upper gastrointestinal tract in comparison with Argon plasma coagulation method.
We will do our study on 40 conscious and stable patients whom will be admitted in Ghaem and Imamreza hospitals of Mashhad due to upper gastrointestinal bleeding from an ulcer with benign endoscopic view. After completing consent form and considering of exclusion criteria, they will be randomized according to the table of numbers into two groups. The first group will be treated with 20cc from 20% Samen-ista emulsion, which is a mineralo-herbal emulsion with anticoagulant property in animal models. This emulsion will be poured on the bleeding ulcer from 2mm distance, via an ERCP-catheter. The patient will be under observation for 5 minutes during the endoscopy to evaluate stop bleeding, if any bleeding was seen after 5 minutes, treatment with Argon plasma coagulation will be done. In the second group the gastrointestinal bleeding will be treated with Argon plasma coagulation method. The rate of success in bleeding control at 5min after treatment during first endoscopy and also in the second endoscopy which will be done 72 hours later will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016033118915N4
Registration date:2016-08-07, 1395/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-07, 1395/05/17
Registrant information
Name
Mousalreza Hosseini
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 80 1274 2513
Email address
hoseinimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashad University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Samen-ista emulsion on treatment of bleeding from benign ulcers of upper gastrointestinal tract in comparison with Argon plasma coagulation method.
Public title
The effect of Samen-ista emulsion on treatment of bleeding from benign ulcers of upper gastrointestinal tract.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients with Upper gastrointestinal bleeding who will be admitted in emergency wards of Ghaem and Imam-reza Hospitals.
Exclusion criteria: Bleeding from esophageal or gastric varices; Bleeding from esophageal or gastric malignancy; Bleeding in a patient with coagulopathy, hematologic malignancy or renal failure.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashad University Of Medical Sciences
Street address
Goreyshi Building, Doktora Square, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
IR.MUMS.REC.1394.564
Health conditions studied
1
Description of health condition studied
Diseases of esophagus, stomach and duodenum
ICD-10 code
K25.0
ICD-10 code description
acute gastric ulcer with hemorrhge
Primary outcomes
1
Description
Bleeding
Timepoint
5 min and third day after procedure
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: The first group will be treated with 20cc from 20% samen-ista emulsion which will be poured on the bleeding ulcer from 2mm distance, via a ERCP-catheter
Category
Treatment - Drugs
2
Description
Control: The second group will be treated with argon plasma coagulation method.