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Investigating the analgesic effect of coccidiary essential oil and lubricant gel in patients referred for colonoscopy; Randomized double-blinded clinical trial

Protocol summary

Study aim
Investigating the analgesic effect of coccidiary essential oil and lubricant gel in patients referred for colonoscopy; Randomized double-blinded clinical trial
Design
Our assumption is that coccidiary herbal medicine, due to the presence of analgesic chemical compounds, can make it easier and more satisfactory for patients to undergo colonoscopy by reducing their pain.
Settings and conduct
Digestive and Liver Research Center, GI and Liver Research Center, Elite Center and Fractional Service
Participants/Inclusion and exclusion criteria
this study, the first coctail drug from southern provinces was collected and after the extraction of essential oil, the essence of the substance was first identified by the method of liquid caratography and its main chemical compounds. Then, based on this and previous studies, the lubricant gel with different percentages (low And much) made from coctite essential oil. Essential Oil Preparation: For the extraction of cocoa juice after collecting and drying in the shade, the Clewinger method and steam distillation at 75 ° C for 3 hours are performed.
Intervention groups
Experimental groups: A total of 200 people who referred for colonoscopy (sample size with Cochran formula) were put in 4 groups (each group was 50 without any indication), group 1 received a lidocaine-free lubricant gel , The second group receiving 2% lidocaine gel, group 3 and 4, respectively, receiving a lubricant gel, receive a low and high concentration of cacti essential oil in the form of blind, triple-blinded. In this way, before completing colonoscopy, the consent form is completed and not a remedy for all patients who use the drug for the purpose of pain relief.
Main outcome variables
pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190722044309N1
Registration date: 2019-09-06, 1398/06/15
Registration timing: retrospective

Last update: 2019-09-06, 1398/06/15
Update count: 0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Ali Ghorbani Ranjbary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 81261
Email address
ali.ghorbaniranjbary@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
2018-10-12, 1397/07/20
Actual recruitment end date
2019-04-30, 1398/02/10
Trial completion date
2019-04-30, 1398/02/10
Scientific title
Investigating the analgesic effect of coccidiary essential oil and lubricant gel in patients referred for colonoscopy; Randomized double-blinded clinical trial
Public title
Investigating the analgesic effect of coccidiary essential oil and lubricant gel in patients referred for colonoscopy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Experimental groups: A total of 200 individuals were assigned in 4 groups to determine the colonoscopy (Sample sample size with Cochran formula) (each group of 50 was unrelated). Group 2 received a non-lidocaine-type lubricant gel receptor group Lidocaine contains 2% throat, group 3 and 4, receptor of glycolate reductant containing low and high Ziziphora tenuior.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 200
Actual sample size reached: 200
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be the permutation block randomization method, in which "A" represents the intervention group receiving one (no lidocaine), and "B" represents the second group receiving lidocaine 2%. Slow. And "c" represents the third group with a low concentration of cocoa and "D" represents the group receiving the high concentration of the drug. This method is based on 9 blocks in 24 permutations, taking into account all possible displacements (ABCD, ACBD, ABDC, BACD, ....) and assigning zero to 24 (according to random number table) to each of these .displacements. , Runs (ABCD code 0, ACBD code 1, CABD code 2, ... up to 24) Then, using a random number table, 9 random numbers (rows or columns) are selected and the permissions assigned to each number are written. (Arrange the permutations side by side, left and right, respectively) and how to assign 200 people to four groups of A B C D
Blinding (investigator's opinion)
Double blinded
Blinding description
Using placebo, the patient and the clinician performing the colonoscopy are kept blind to the study group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baghiyyatollah al-Azam Military Hospital
Street address
The Baghiyyatollah al-Azam Military Hospital is a military hospital in Mulla Sadra Street in Vanak, Tehran, Iran. The hospital has ties with the Baqiyatallah University of Medical Sciences.
City
TEHRAN
Province
Tehran
Postal code
141556437
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.BMSU.REC.1396.719

Health conditions studied

1

Description of health condition studied
CRC: IBD::Anal anesthesia
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified

Primary outcomes

1

Description
Pain during a colonoscopy
Timepoint
1
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: receiving a low concentration of cacti essential oil .
Category
Treatment - Drugs

2

Description
Intervention group: receiving a high concentration of cacti essential oil .
Category
Treatment - Drugs

3

Description
Control group: Lidocaine-free lubricant gel recipient
Category
Treatment - Drugs

4

Description
Control group: Gel recipient containing 2% lidocaine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghiyyatollah Al-Azam Military Hospital
Full name of responsible person
Mohammad Roshani
Street address
Mollasadra street
City
Tehran
Province
Tehran
Postal code
8805 0435
Phone
+98 21 8805 0435
Email
bmsu@ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Moayed Alavian
Street address
Baqiyatallah University of Medical Sciences
City
tehran
Province
Tehran
Postal code
8248 3131
Phone
+98 21 8248 3131
Email
sm_alavian@alavian-thc.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Moayed Alavian
Position
Professor of Gastroenterology and Hepatology
Latest degree
Subspecialist
Other areas of specialty/work
Health Promotion
Street address
Baqiyatallah University of Medical sciences
City
tehran
Province
Tehran
Postal code
8248 313120
Phone
+98 21 8248 3131
Email
sm_alavian@alavian-thc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Ghorbani Ranjbary
Position
free
Latest degree
Medical doctor
Other areas of specialty/work
Medical Biology
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8248 313122
Phone
+98 21 8248 3131
Email
ali.ghorbaniranjbary@mail.um.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Ghorbani Ranjbary
Position
free
Latest degree
Medical doctor
Other areas of specialty/work
Medical Biology
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8248 313122
Phone
+98 21 8248 3131
Email
ali.ghorbaniranjbary@mail.um.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
Undecided - It is not yet known if there will be 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
no
When the data will become available and for how long
5m
To whom data/document is available
all
Under which criteria data/document could be used
Article
From where data/document is obtainable
Article
What processes are involved for a request to access data/document
Article
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