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
Investigation of the effect of Samen-ista emulsion on the treatment of upper gastrointestinal non-bleeding visible vessel
Design
This clinical trial is carried out on 90 patients in 3 groups of 30 people including 2 control groups. Single-blinding is done and simple randomization is performed.
Settings and conduct
Patients with gastrointestinal bleeding who refer to the emergency wards of Imam Reza and Ghaem Hospitals in Mashhad are enrolled in the study. Prior to endoscopy, all patients fill out informed written consent forms and then undergo one of the following treatments: a) adrenaline injection and Argon plasma coagulation or b) adrenaline injection and clips or c) treatment with Samen-ista powder. Randomization is done through a randomization table. 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 method will be determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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. Exclusion criteria: all types of bleeding except bleedings caused by a non-bleeding visible vessel, pregnancy, hemodynamic instability during endoscopy, peptic ulcers that have undergone endoscopic treatment within the last 7 days, Thrombocytopenia, kidney failure
Intervention groups
Patients with a non-bleeding visible vessel in the endoscopy, receive ulcer treatment in Intervention group: through lavage with Samen-ista emulsion, in control group1: through adrenaline injection and Argon plasma coagulation, in control group2: through adrenaline injection and clips
Main outcome variables
Investigation of rate of complications (rebleeding) after Using Samen-ista powder on non-bleeding visible vessel in endoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140824018915N6
Registration date:2018-04-27, 1397/02/07
Registration timing:registered_while_recruiting
Last update:2018-04-27, 1397/02/07
Update count:0
Registration date
2018-04-27, 1397/02/07
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
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigation of the effect of Samen-ista emulsion on the treatment of upper gastrointestinal non-bleeding visible vessel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.MUMS.fm.REC.1396.652
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 hemorrhage
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: If there is a non-bleeding visible vessel in endoscopy, ulcer treatment will be done through adrenaline injection and Argon plasma coagulation
Category
Treatment - Drugs
3
Description
Control group: If there is a non-bleeding visible vessel in endoscopy, ulcer treatment will be done through adrenaline injection and clips
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr Mousalreza Hoseini
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
Email
hoseinimr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Abbas Hasanzadeh
Position
student of sub specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Sq, Ebne-Sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3801 2769
Email
HasanzadehA951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In case organizations ask for the data of participants, the data will become accessible for them.
When the data will become available and for how long
The data can be accessible for specific organization request 6 month after the article is published.
To whom data/document is available
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.
Under which criteria data/document could be used
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.
From where data/document is obtainable
Through sending an email to the corresponding author, data will be obtainable.
What processes are involved for a request to access data/document
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.