Effect of indomethacin suppository plus oral CoQ10 verusus indomethacin suppository in prevention of post Endoscopic Retrograde Cholangio-pnacreatography pancreatitis
Comparing the effect of single dose of rectal Indomethacin plus CoQ10 tablet versus single dose of rectal indomethacin on prevention of post Endoscopic Retrograde cho;angio-pancreatography pancreatitis
Design
A randomized, controlled clinical trial with a parallel group on 200 patients.
Settings and conduct
This trial will be done in Endoscopy ward of Talighani hospital, Tehran.200 patients with indication of Endoscopic Retrograde Cholangiopancreatography will be considered for the study. All patients will recieve 100 mg indomethacin rectally just before doing procedure. Patients devided in two groups; to receive the CoQ10 or nothing. Patients in the CoQ10 group received two tablets of 100 mg CoQ10 two hours before doing Cholangiopancreatography. All patients were followed-up for occurrence of post Endoscopic Retrograde Cholangiopancreatography pancreatitis. Endoscopic Retrograde Cholangiopancreatography pancreatitis will defined severe abdominal pain that necessitate hospitalization of a minimum of 48 hours and an elevated serum amylase/serum lipase level of more than 3 times the upper limit of normal.The rate of pancreatitis will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 200 patients who undergo Endoscopic Retrograde Cholangiopancreatography between 20 to 80 years old and by taking consent inform will be enrolled in this study. Exclusion criteria: patients with history of hypersensitivity to each of indomethacin or CoQ10.
Intervention groups
Group1: Adminstration of single dose of 100 mg rectal indomethacine just before plus oral coQ10 200 mg two hours before doing Endoscopic cholangiopancreatography Group2: Administration of single dose of 100 mg rectal indomethacin just before doing Endoscopic cholangiopancreatography
Main outcome variables
Pancreatitis occurence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N13
Registration date:2022-09-28, 1401/07/06
Registration timing:prospective
Last update:2022-09-28, 1401/07/06
Update count:0
Registration date
2022-09-28, 1401/07/06
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-01, 1401/07/09
Expected recruitment end date
2022-12-30, 1401/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of indomethacin suppository plus oral CoQ10 verusus indomethacin suppository in prevention of post Endoscopic Retrograde Cholangio-pnacreatography pancreatitis
Public title
Comparing the rectal Indomethacin plus oral coQ10 versus rectal indomethacin on prevention of post Endoscopic Retrograde Cholangio-pnacreatography pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing ERCP in Taleghani hospital by taking written consent
Exclusion criteria:
Patients history of hypersensitivity against each of indomethacin or coQ10
History of sphinctrotomy
Age
From 20 years old to 80 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 pharmacy, nursing and midwifery of Shahid Beheshti university of medical science
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2022-08-09, 1401/05/18
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.091
Health conditions studied
1
Description of health condition studied
pancreatitis
ICD-10 code
Other acut
ICD-10 code description
K85.8
Primary outcomes
1
Description
Pancreatitis
Timepoint
10 days after doing Endoscopic Retrograde Cholangio-pancreatography
Method of measurement
clinical evaluation
Secondary outcomes
1
Description
gastrointestinal bleeding
Timepoint
10 days after doing ERCP
Method of measurement
Clinical observation
Intervention groups
1
Description
Intervention group: Administration of single dose of 100 mg rectal Indomethacine just before plus 200 mg CoQ10 tablet 2 hours before doing Endoscopic cholangiopancreatography
Category
Prevention
2
Description
Control group: Administration of single dose of 100 mg rectal indomethacine just before doing Endoscopic cholangiopancreatography
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of pharmacy, Shahid Behesti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hassan Yazdanpanah
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8866 5282
Email
yazdanpanah@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of PharmacyNyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of PharmacyNyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.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
All data can be shared after deidentified
When the data will become available and for how long
starting in ِJuly 2023
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
with written consent
From where data/document is obtainable
Sending email to: m_abbasi@sbmu.ac.ir
What processes are involved for a request to access data/document