The effect of rosa damascena oil capsule in reducing ileus after colorectal surgery
Design
The study will be double blind and clinical trial.84 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients candidate for colorectal surgery in valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age between 18 and 80 years, do not enter patients with coagulation problems who are unable to discontinue their medication, failure to enter patients receiving regular glucocorticoids and nonsteroidal anti-inflammatory drugs more than three days a week for the past 28 days, do not take aspirin daily at a dose of more than 150 mg, no acute peptic ulcer or its complications, failure to receive antibiotic treatment to eradicate Helicobacter pylori in the last 28 days, do not smoke or drink alcohol, lack of sensitivity to sesame and its products
Exclusion criteria: Incidence of complications compared to rosemary during treatment ,the patient's unwillingness to continue treatment
Intervention groups
Intervention group: Two soft capsules of Golmohammadi (Barij Esans .Co) are taken orally three times a day for 3 days with routine care.
Control group: receive routine care and placebo in the same way and number of intervention drugs.
Main outcome variables
Incidence of ileus, time of first gas excretion, duration of hospital stay, abdominal distension, abdominal circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N173
Registration date:2022-04-09, 1401/01/20
Registration timing:registered_while_recruiting
Last update:2022-04-09, 1401/01/20
Update count:0
Registration date
2022-04-09, 1401/01/20
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-09-11, 1401/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rosa damascena oil capsule in reducing ileus after colorectal surgery
Public title
The effect of rosa damascena oil capsule in reducing ileus after colorectal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 80 years
Do not enter patients with coagulation problems who are unable to discontinue their medication
Failure to enter patients receiving regular glucocorticoids and nonsteroidal anti-inflammatory drugs more than three days a week for the past 28 days
Do not take aspirin daily at a dose of more than 150 mg
No acute peptic ulcer or its complications
Failure to receive antibiotic treatment to eradicate Helicobacter pylori in the last 28 days
Do not smoke or drink alcohol
Lack of sensitivity to sesame and its products
Exclusion criteria:
The patient's unwillingness to continue treatment
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind study. Analysts, evaluators, and participants are unaware of the grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-02-13, 1400/11/24
Ethics committee reference number
IR.ARAKMU.REC.1400.323
Health conditions studied
1
Description of health condition studied
Colorectal surgery
ICD-10 code
K56.49
ICD-10 code description
Other impaction of intestine
Primary outcomes
1
Description
Incidence of ileus
Timepoint
Before and after intervention
Method of measurement
Number
2
Description
Time of first gas excretion
Timepoint
After of surgery
Method of measurement
Minute
3
Description
length of hospital stay
Timepoint
After intervention
Method of measurement
day
4
Description
Abdominal distension
Timepoint
Before and after intervention
Method of measurement
Observation
5
Description
Abdominal circumference
Timepoint
Before and after intervention
Method of measurement
Centimeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two soft capsules of Golmohammadi (Barij Esans .Co) are taken orally three times a day for 3 days with routine care.
Category
Treatment - Drugs
2
Description
Control group: receive routine care and placebo in the same way and number of intervention drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Reza Shojaee
Street address
Valiasr squre, Valiasr hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
shojaee@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
kamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Reza Shojaee
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street