Investigating the effect of Cuminum Cyminum on the return of intestinal peristaltic movements after abdominal surgeries in patients who hospitalized in the surgery ward of Ali Ibn Abi Taleb Hospital of Rafsanjan, 2021
Determination the effect of Cuminum Cyminum on the return of intestinal peristaltic movements after abdominal surgeries
Design
Randomized, parallel group trial with blinded drug and outcome assessment
Settings and conduct
In this randomized clinical trial, the study population are candidates for abdominal surgery who will admitted to the Ali Ibn Abitaleb Hospital of Rafsanjan. Participants will select by convenience sampling method based on inclusion criteria of the study. Random allocation of the participants will carry out using the minimization method based on type of surgery and sex variables. Participants will be divided into two groups of intervention (will receive 250 mg capsule of Cuminum Cyminum extract 4 hours after surgery and one hour after the first dose of this drug) and control (will receive placebo exactly like the intervention group). Demographic questionnaire and the check list for recording of bowel movement are data collection tool which will completed each 2 hours after the surgery until to 24 hours in both groups.
Participants/Inclusion and exclusion criteria
Age between 18-60 years, candidate for abdominal surgery, general anesthesia, inform consent for participate in the study are inclusion criteria. Use of Cuminum Cyminum permanently, pregnancy and lactation, addiction, use of alcohol, history of liver, kidney, heart and thyroid disorders, use of anticoagulant drugs, use of psychiatric drugs and gastric perforation are exclusion criteria.
Intervention groups
Intervention group: In this group, patients receive a 250 mg capsule of Cuminum Cyminum extract 4 hours after surgery and one hour after the first dose of this drug.
Control group: In this group, patients will receive placebo ( a 250 mg capsule of starch) exactly like the intervention group.
Main outcome variables
First gas passing
First defecation
Abdominal bloating
Abdominal pain
Nausea
Vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150713023190N10
Registration date:2021-10-24, 1400/08/02
Registration timing:registered_while_recruiting
Last update:2021-10-24, 1400/08/02
Update count:0
Registration date
2021-10-24, 1400/08/02
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Cuminum Cyminum on the return of intestinal peristaltic movements after abdominal surgeries in patients who hospitalized in the surgery ward of Ali Ibn Abi Taleb Hospital of Rafsanjan, 2021
Public title
Effect of Cuminum Cyminum on the return of intestinal peristaltic movements after abdominal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-60 years
Candidate for abdominal surgery
General anesthesia
Inform consent for participate in the study
Exclusion criteria:
Use of Cuminum Cyminum permanently
pregnancy and lactation
Addiction
Use of alcohol
History of liver, kidney, heart and thyroid disorders
Use of anticoagulant drugs
Use of psychiatric drugs
Gastric perforation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as type of surgery and gender. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient will not know that he/she is in the intervention group or control. The capsules will be prepared by pharmacist and the researcher will not be aware of the capsules. The analyzer will not know the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.RUMS.REC.1400.135
Health conditions studied
1
Description of health condition studied
Return of intestinal peristaltic movements
ICD-10 code
R19.11
ICD-10 code description
Absent bowel sounds
Primary outcomes
1
Description
First gas passing
Timepoint
After the intervention
Method of measurement
Checklist (patient’ response will be recorded in the checklist)
2
Description
First defecation
Timepoint
After the intervention
Method of measurement
Checklist
3
Description
Abdominal bloating
Timepoint
2 hour after the intervention until 24 hours
Method of measurement
Checklist
4
Description
Abdominal pain
Timepoint
2 hour after the intervention until 24 hours
Method of measurement
Checklist
5
Description
Nausea
Timepoint
2 hour after the intervention until 24 hours
Method of measurement
Checklist
6
Description
Vomiting
Timepoint
2 hour after the intervention until 24 hours
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients receive a 250 mg capsule of Cuminum Cyminum extract 4 hours after surgery and one hour after the first dose of this drug.
Category
Treatment - Other
2
Description
Control group: In this group, patients will receive placebo (a 250 mg capsule of starch) exactly like the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital
Full name of responsible person
Ali Mousavi
Street address
Mofateh Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
aliebn@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsi Zadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Amin Esmaeili Abdar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
amin31401@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.b_sadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.b_sadeghi@yahoo.com
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
Confidentiality of data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available