1. Home
  2. Approved trials
  3. » فارسی

Comparing the effects of mint and cuminum extract on residual volume and abdominal distention in patients under mechanical ventilation

Protocol summary

Study aim
Comparing the effects of mint and cuminum extract on residual volume and abdominal distention in patients under mechanical ventilation
Design
A randomized clinical trial with 3 groups(peppermint, cuminum and control), without blinding, phase II, conducted on 114 patients. Randomization will be performed using sequentially numbered, sealed envelopes.
Settings and conduct
This study will be conducted on mechanically ventilated patients in Ghaem and Imam Reza hospitals in Mashhad. Eligible patients will be enrolled in the study after assessment of the inclusion criteria and obtaining informed consent from the patient or their legal representative. participants will be randomly assigned to 3 groups: peppermint, cuminum and control groups. The intervention groups will receive peppermint or cuminum extract according to the study protocol, and the control group will receive routine care of the ward. GRV and abdominal distention will be measured and recorded at the predetermined times according to the study protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Under mechanical ventilation, Age18 years or older, At least24 hours have passed since admission, Hemodynamically stable, Receiving enteral nutrition via NGT, Informed consent from the patient or their legal representative; Exclusion criteria: allergy to peppermint or cuminum, pregnant or breastfeeding, hypothyroidism, active GI bleeding or peptic ulcer, gallstone or liver failure
Intervention groups
In this study, there will be 3 groups: peppermint, cuminum and control groups. The peppermint group will receive peppermint extract according to the study protocol, the cuminum group will receive cuminum extract according to the study protocol. The control group will receive routine care of the ward and will not receive the herbal intervention.
Main outcome variables
Gastric residual volume; abdominal distention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260617069846N1
Registration date: 2026-06-28, 1405/04/07
Registration timing: prospective

Last update: 2026-06-28, 1405/04/07
Update count: 0
Registration date
2026-06-28, 1405/04/07
Registrant information
Name
Helia Gerami Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3871 8031
Email address
geramimh4022@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-01, 1405/04/10
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of mint and cuminum extract on residual volume and abdominal distention in patients under mechanical ventilation
Public title
Evaluating the effects of peppermint and cumin extract on gastric residual volume and abdominal distension in mechanically ventilated patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be under mechanical ventilation Be aged 18years or older At least 24 hours have elapsed since admission Be hemodynamically stable Receiving enteral nutrition via NGT The patient or their legal representative provides informed consent
Exclusion criteria:
The patient has an allergy to peppermint or cumin The patient is pregnant or breastfeeding The patient has GI Bleeding or peptic ulcer disease The patient has gallstone or liver failure
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
A random allocation sequence will be generated using randomization software. Allocation codes will be placed in sequentially numbered, opaque, sealed envelopes. After each eligible patient is enrolled, the next envelope in numerical order will be opened, and the patient will be assigned to one of the three study groups: peppermint, cumin, or control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
4th Floor, Shahid Dr.Kharazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2026-06-02, 1405/03/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1405.029

Health conditions studied

1

Description of health condition studied
Under mechanical ventilated patients
ICD-10 code
Z99.1
ICD-10 code description
Dependence on respirator

Primary outcomes

1

Description
Gastric residual volume
Timepoint
Measurements will be performed immediately before and 3 hours after gavage administration of the respective extract at12,18, and24 hours.
Method of measurement
It will be measured using 50cc syringe.

2

Description
Abdominal distention
Timepoint
Measurements will be performed immediately before and 3 hours after gavage administration of the respective extract at12,18, and24 hours.
Method of measurement
Measurements will be performed using measuring tape ( with an accuracy of 0.5 cm) before and 3 hours after gavage administration of the study extracts (at 12, 18,and 24).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Patients in this group will receive peppermint extract manufactured by Barij Essence Pharmaceutical Company. This product contains the main active constituents of peppermint, including menthol and menthone. This intervention will be administered as 20 drops of peppermint extract diluted in 30cc of drinking water via a NGT at 9, 15 ,21. The duration of the intervention will be 24 hours. Intervention group2: Patients in this group will receive Cuminum cyminum extract manufactured by Barij Essence Pharmaceutical Company. This product contains the main active constituents of cumin, including cuminaldehyde and other volatile compounds. This intervention will be administered as 20 drops of cumin extract diluted in 30cc of drinking water via a NGT at 9, 15 ,21. The duration of the intervention will be 24 hours.
Category
Treatment - Drugs

2

Description
Control group: Patient in this group will receive routine ward care and will not receive any herbal intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital of Mashhad
Full name of responsible person
Mahmood Bakhshi
Street address
Ghaem(AJ) Educational, Research and treatment Center, Ahmadabad Street, Dr.Shariati(Taghiabad) Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
4578591871
Phone
+98 51 3840 0000
Email
ghaeminthospital@gmail.com

2

Recruitment center
Name of recruitment center
Imam Reza hospital of Mashhad
Full name of responsible person
Mahmood Bakhshi
Street address
Imam Reza Hospital, Imam Reza Square, Ibn Sina Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
1331691379
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
4th Floor, Research Deputy Office, Shahid Dr.Kharazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahmood Bakhshi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
Bakhshim@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmood Bakhshi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
Bakhshim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmood Bakhshi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
Bakhshim@mums.ac.ir

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
Protection of Privacy
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study protocol of the clinical trial including objectives, methodology, interventions, outcomes, and statistical analysis plan.
When the data will become available and for how long
The study protocol will be available from the time of trial registration and throughout the study period.
To whom data/document is available
Researchers, peer reviewers, ethic committees, and other authorized individuals.
Under which criteria data/document could be used
For research transparency, methodology assessment, and scientific use with appropriate citation.
From where data/document is obtainable
Requests for access to the study protocol should be directed to Dr. Mahmood Bakhshi, Head of the Medical_Surgical Nursing Department, School of Nursing and Midwifery, Mashhad University of Medical Sciences, and the principal supervisor of the study, through Mashhad University of Medical Sciences.(mail: Bakhshim@mums.ac.ir)
What processes are involved for a request to access data/document
Requests should be submitted in writing or by email to the principal investigator. The request will be reviewed in terms of its intended purpose and its compliance with scientific and ethical considerations. Upon approval by the principal investigator and the study's primary supervisor, the study protocol will be made available to the applicant via email or other official means.
Comments
Loading...