comparison of the effectiveness and patient tolerance of oral lavage of Rhamnus frangula extract and polyethylene glycol for colonoscopy preparation. A randomized controlled trial study
comparison of the effectiveness and patient tolerance of administration of Rhamnus frangula extract and polyethylene glycol in bowel preparation for colonoscopy
Design
This study is a randomized, double-blind clinical trial with parallel groups and a control group that will be performed with the participation of 116 patients ; Patients will be divided into intervention and control groups by block randomization
Settings and conduct
The samples will be selected from patients referred to the gastroenterology clinics of Emam Reza hospital of Tabriz .patients will be placed in one of the two groups receiving the Pidrolox and Rhamnus frangula extract sachetes. The Pidrolox group will prepare 4 packets of Pidrolox consuming 24 hours before the colonoscopy. The Rhamnus frangula group will also take 2 grams of Rhamnus frangula in 4 sachets .bowel preparation will be assessed by BOSTON score.researchers and patients and data analyzer will be blind in this study.
Participants/Inclusion and exclusion criteria
patients will be selected from the person referred to Gastroenterology clinics for colonoscopic evaluation, Inclusion criteria include: Age at 18-75 year, and willingness to participate,exclusion criteria also include:history of drug reaction, having dysphagia;swallowing disorders;ileus ;pregnancy and lactation
Intervention groups
This study will be a randomized, double -blind clinical trial with parallel groups; 116 people will be randomly divided into two groups. Patients in the intervention group will take Rhamnus frangula extract sachetes before colonoscopy and control group will receive Pidrolax sachetes before colonoscopy.
Main outcome variables
bowel preparation BOSTON score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053626N4
Registration date:2022-12-21, 1401/09/30
Registration timing:prospective
Last update:2022-12-21, 1401/09/30
Update count:0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Masood Dinevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dinvarim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness and patient tolerance of oral lavage of Rhamnus frangula extract and polyethylene glycol for colonoscopy preparation. A randomized controlled trial study
Public title
effectiveness and patient tolerance of oral lavage of Rhamnus frangula extract for colonoscopy preparation
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
age 18-75
willingness to participate
Exclusion criteria:
any history of drug reaction
history of disphagia and swallowing dysfunction
history of ileus and bowel obstruction and gastroparesia
active inflammatory bowel disease
electrolyte imbalance
renal and liver failure
pregnancy and lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
From the patients who volunteered to participate in the study, 116 persons will be selected by simple random sampling.
Randomization method:block
Randomization unit : Individual
Randomization layers: In each block, people will be matched based on age and gender.
Random Allocation software: Random Allocation software
How to create a random sequence: Using Random Allocation software
Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of supplement received. Supplements will be provided to patients by another person who has no role in completing the questionnaire and performing colonoscopy. Patients will also be informed of the existence of two types of supplements (polyethylen glycol and Rhamnus frangula extract) when obtaining consent, but will be unaware of which study groups they will be included in. Rhamnus frangula extract sachetes are similar in appearance color, and size to polyethylen glycol sachetes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethic committee, Vice chancellor for research, Faculty of medicine, Tabriz University of Medical Sciences,Golgasht st, Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.TBZMED.REC.1400.936
Health conditions studied
1
Description of health condition studied
bowel preparation for colonoscopy
ICD-10 code
Z12.11
ICD-10 code description
Encounter for screening for malignant neoplasm of colon
Primary outcomes
1
Description
bowel preparation score
Timepoint
after intervention
Method of measurement
BOSTON score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will receive 4 sachetes each contain of 500mg Rhamnus frangula extract which will dissolve in a liter of water. they will receive a glass every 6 hours 24 hours before the colonoscopy ,In order to prepare Rhamnus frangula sachet, frangula fruit will be purchased from reputable centers and then dried in a drying machine and ground in a special herb grinder and packed as a powder in the sachetes.
Category
Treatment - Drugs
2
Description
2nd intervention group: . All patients will receive 4 sachetes of Pidrolax each dissolved in 1litre water and will take a glass every 20 minutes 24 hours before colonoscopy. Pidrolox sachets containing polyethylene glycol 4000 will belong to Sepidaj company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Masood Faghih Dinevari
Street address
Emam reza hospital, Golgast st,Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
566614766
Phone
+98 41 3334 4918
Email
masood.dinevari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Vice chancellor for Research,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3337 2084
Email
Shahabi_p@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Masood faghih Dinevari
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Email
dinvarim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masood Faghih Dinevari
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Email
dinvarim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masood faghih Dinevari
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Email
dinvarim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD