Determine the effect of Chamomile on the incidence and severity of nausea and vomiting after middle ear surgery
Design
A controlled, parallel-group, triple-blind, randomized clinical trial on 110 patients. A coin toss was used for randomization
Settings and conduct
This three-blind study will be conducted in the otolaryngology department of Hazrat Rasool Akram Hospital in Tehran. The person taking the sample, the patient, and the statistical analyst will not know about the random allocation of the samples. 110 patients who meet the conditions to enter the study will be selected as available after providing explanations and with informed consent and will be distributed into two control and intervention groups based on random allocation by tossing a coin. In the intervention group, 50 patients Chamomile capsule of 500 mg, and in the control group, 50 patients will receive the placebo capsule one hour before the operation. After surgery, immediately after recovery from anesthesia, one hour, two hours, four hours, and six hours after recovery, patients will complete Roder's questionnaire according to their symptoms.
Participants/Inclusion and exclusion criteria
Age 18 to 65 years; ASA I and ASA II; Not taking anti-emetic medication 24 hours before surgery; platelet count above 10,000; Weight less than 90 kg; Not suffering from any liver (hepatitis, coagulation disorders), kidney (kidney stones, kidney failure) and digestive (gastric ulcer and duodenal ulcer); no history of motion sickness; not having cancer; being an NPO; No history of hypertension; no history of epilepsy; lack of pregnancy; not smoking; Absence of allergy to chamomile
Intervention groups
Intervention group: patients who receive 500 mg chamomile capsules 1 hour before surgery
Control group: patients who receive placebo capsules 1 hour before surgery
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210109049973N1
Registration date:2023-11-25, 1402/09/04
Registration timing:registered_while_recruiting
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
parisa Moradimajd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4772
Email address
moradimajd.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chamomile on the incidence and severity of nausea and vomiting on patients undergoing middle ear surgery
Public title
The effect of chamomile on the incidence and severity of nausea and vomiting after middle ear surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18_65 years old
ASA I and ASA II
Not taking antiemetic drugs 24 hours before surgery
Platlate count above 100000
Weight less than 90 kg
No liver disease (hepatitis, coagulation disorder), renal disease (kidney stone, renal failure), and gastrointestinal (stomach ulcer, duodenal ulcer)
No history of motion sickness
No cancer
Being NPo
No history of hypertension
No history of epilepsy
No pregnancy
No smoking
No allergies to chamomile
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are selected as available and will be distributed in two intervention and control groups based on random allocation by tossing a coin (on the back and on the coin). In this way, the face of the coin will be related to the intervention group and the back of the coin will be related to the control group. After entering the patients and checking the entry criteria, a coin will be tossed by an unknown person to assign the groups. If the coin comes up, the patient will enter the intervention group, and if the coin comes up, the patient will be in the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For blindness, according to the triple-blind approach, the capsules made with the same shape by the pharmacist are placed in two envelopes. the person doing sampling, the patient receiving medication, and finally the statistical consultant analyzing data do not know about the allocation of samples in control and intervention groups. the intervention group will be identified by the letter A and the control group by the letter B to prevent bias in collecting and recording the results of the study and to generalize the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-07-18, 1400/04/27
Ethics committee reference number
IR.IUMS.REC.1400.378
Health conditions studied
1
Description of health condition studied
Post anesthesia nausea and vomiting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Rate of nausea and vomiting after middle ear surgery
Timepoint
Immediately after recovery from anesthesia, 1, 2, 4 and 6 hours after recovey from anesthesia
Method of measurement
Rhodes index
2
Description
Vital sign
Timepoint
Immediately, 1,2,4,6 hours after recovery from anesthesia
Method of measurement
Observation, termometer and blood pressure monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients who receive 500 mg chamomile capsules 1 hour before surgery
Category
Prevention
2
Description
Control group: patients who receive placebo (corn starch) 1 hour before surgery
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate rasool akram hospital
Full name of responsible person
Parisa moradi majd
Street address
Hazrate rasool akram hospital_next to Mansoori street_Niyayesh street_Saatarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1000
Email
moradimajd.p@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran university of medical sciences,next to milad tower, hemmat highway, tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4772
Email
moradimajd.p@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Parisa Moradi Majd
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Iran university of medical sciences,next to milad tower, hemmat highway, tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4772
Email
moradimajd.p@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa moradi majd
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Iran university of medical sciences,next to milad tower, hemmat highway, tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4772
Email
moradimajd.p@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Moradi Mjad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Iran university of medical sciences, next to milad tower, hemmat high way, tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4772
Email
moradimajd.p@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data cannot be shared
When the data will become available and for how long
None
To whom data/document is available
None
Under which criteria data/document could be used
Only in situations where a meta-analysis is to be performed
From where data/document is obtainable
Parisa Moradi Majd
moradimajd.p@gmail.com
What processes are involved for a request to access data/document