Investigating the effect of cumin and sumac products in preventing nausea and vomiting after surgery
Design
A clinical trial with a control group with parallel and double-blind randomized phase 3 trials on 120 patients, which will be used for randomization using random permutation blocks
Settings and conduct
In Pasteur Bam Hospital, 120 people are randomly selected to investigate the effect of cumin and sumac plant products on nausea and vomiting after surgery and they are divided into two treatment groups and control groups using the random permutation block method. The study uses sachets of one color and one shape to make a placebo. To give medicine, a reliable person is chosen and by using random permutation block method, it is determined what medicine each person will receive.
Participants/Inclusion and exclusion criteria
Entry requirements: age between 18 and 65 years old;Absence of stomach and intestinal ulcers.;Absence of intestinal obstruction
Conditions of non-entry: occurrence of any symptoms of allergy to the herbal product during treatment; observation of any complications during treatment
Intervention groups
Investigating the effectiveness of cumin and sumac herbal product on nausea and vomiting after surgery, the subjects in the case group received 2 four-gram sachets containing sumac and cumin and the control group received 2 sachets containing corn starch and caramel as a placebo.
Main outcome variables
the severity of nausea; the number of times of vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220912055947N1
Registration date:2022-12-11, 1401/09/20
Registration timing:registered_while_recruiting
Last update:2022-12-11, 1401/09/20
Update count:0
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
mohadeseh nasehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4434 0768
Email address
mohinasehi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sumac and cumin plant products in preventing nausea and vomiting after surgery
Public title
the effect of cumin and Kermani sumac herbal product in preventing nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age between 18 and 65 years 2) Absence of underlying disease including diabetes, heart, kidney, liver, and Malori Weiss disease 3) Absence of stomach and intestinal ulcers 4) Declaration of consent to participate in the research and signing the informed consent form 5) Absence of obstruction Gut 6) Absence of sensitivity to sumac and cumin
Exclusion criteria:
The patient's unwillingness to continue the treatment
Failure to respond to herbal medicine
Occurrence of any symptoms of allergy to the herbal product during treatment
Observing any complications during treatment
Parkinson's disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible patients are randomly assigned to treatment and control groups using a random number table using random permutation blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to give medicine to patients in the hospital, a reliable person who has sufficient knowledge to do this work is selected and by using random permutation block method, it is determined what medicine each person will receive.The researcher and the patient do not know what medicine is received.Drug and placebo are similar in term of shape and appearance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bam University of Medical Sciences
Street address
Pastor Hospital, Kilometer 5 Bam Baravat Road , Bam,Kerman
City
Bam
Province
Kerman
Postal code
7661961676
Approval date
2022-05-18, 1401/02/28
Ethics committee reference number
IR.MUBAM.REC.1401.027
Health conditions studied
1
Description of health condition studied
Nausea and vomiting after surgery
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
severe nausea
Timepoint
At zero hours, 4 hours after surgery, 8 hours after surgery, 16 hours after surgery, 24 hours after surgery, the severity of nausea and frequency of vomiting during the 24-hour period are evaluated.
Method of measurement
VAS criterion
2
Description
Number of times vomiting
Timepoint
At zero hours, 4 hours after surgery, 8 hours after surgery, 16 hours after surgery, 24 hours after surgery, the severity of nausea and frequency of vomiting during the 24-hour period are evaluated.
Method of measurement
VAS criterion
Secondary outcomes
1
Description
Nember of times vomiting
Timepoint
At the beginning of the study, 4, 8, 16, 24 hours after surgery
Method of measurement
VAS criterion
Intervention groups
1
Description
Intervention group: Method First, the alcoholic extract of the formulation is prepared, then the total phenolic content is measured using Fulin-Sio-Calto reagent. 0.5 ml of the extract is added to 2.5 ml of Folin Sio Calto 0.2 normal reagent, after 5 minutes 2 ml of 75 g/l sodium carbonate solution is added to it. After 2 hours, absorbance of the mixture at 760 nm wavelength is read by a spectrophotometer against a blank. To determine the amount of the sample, tannic acid standard is used to draw the calibration chart.This test is performed three times. In order to determine the amount of raw material ash, which is used to check the percentage of raw material impurities, first, 5 grams of the weighed sample is poured into a porcelain crucible that has already been cleaned, dried and weighed. then the plants are placed in an electric furnace and heated for 6 hours at a temperature of 400-500 degrees Celsius, and then the samples are placed in a desiccator and weighed after cooling. The percentage of total ash is calculated by dividing the difference of the final weight of the plant from the initial plant by the weight of the sampled material and the result is reported as a percentage.In order to determine the moisture level of the plant, 5 grams of the medicinal plant sample is placed in a clean porcelain crucible at a temperature of 100 degrees Celsius for 24 hours, and the weight loss of the sample is presented as a percentage. In order to perform microbial tests of the formulation sample, first 5 grams of phosphate buffer solution with pH = 7.2 is added to the sample, then the plate-cont method according to the USP pharmacopoeia is used. In this way, one milliliter of the prepared sample is poured into a petri dish and 15 to 20 milliliters of Soybean Casein Digest Agar or Sabouraud Dextrose Agar are added to it.The plates are kept at a temperature of 30-35 degrees Celsius for one week, then the number of colonies created is counted. People in the case group receive 2 four-gram sachets containing sumac and cumin. Sachets containing sumac and cumin products are taken every 12 hours, 24 hours before surgery, along with a glass of cool water.
Category
Treatment - Drugs
2
Description
Control group:People in the control group receive 2 sachets containing corn starch and caramel as a placebo in the same way. The way of consuming the diet is that the patients take the sachets containing placebo together with a glass of cold water, 24 hours before surgery. They eat every 12 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pastor Bam Hospital
Full name of responsible person
mohadeseh nasehi
Street address
Kerman, Bam, Kilometer 5 Bam Road, Barat, Pastor Hospital
City
bam
Province
Kerman
Postal code
7661961676
Phone
+98 34 4431 9400
Email
info@mubam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Sajjad Khosravi
Street address
Kerman, Bam, Kilometer 5 Bam Road, Barat, Pastor Hospital
City
bam
Province
Kerman
Postal code
7661961676
Phone
+98 34 4431 9400
Email
info@mubam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bam 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
Bam University of Medical Sciences
Full name of responsible person
mohadeseh nasehi
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bam Moalem Blvd. 12 Moalem Alley
City
bam
Province
Kerman
Postal code
7661745937
Phone
+98 34 4434 0768
Email
mohinasehi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
mohadeseh nasehi
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bam Moalem Blvd. 12 Moalem Alley
City
bam
Province
Kerman
Postal code
7661745937
Phone
+98 34 4434 0768
Email
mohinasehi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
mohadeseh nasehi
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bam Moalem Blvd. 12 Moalem Alley
City
bam
Province
Kerman
Postal code
7661745937
Phone
+98 34 4434 0768
Email
mohinasehi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available