Objective: determine the effect of peppermint drop to improve bowel function after cesarean. Design: The population of the study included 102 elective cesarean women at 38-40 week of gestational age who underwent spinal anesthesia. The simple double blind randomization is done by using closed envelopes. The two groups were homogeneous in type of anesthesia and the time of operation(30-40 minutes). This study is in Phase 1. Setting and conduct:Elective cesarean section women at 38-40 week of gestational age under the spinal anesthesia were enrolled. One group of patients with 20 drops of mint in 30 cc of water will be treated and one group of patients with 20 drops of placebo in 30 cc water will be treated, Which begins 4 hours after the surgery and is repeated at intervals of one hour in three doses. The patients are then clinically examined for intestinal dysfunction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030632909N1
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Seyede hoora Mosavi vahed
Name of organization / entity
Mashhad Medical University
Country
Iran (Islamic Republic of)
Phone
+98 51 3224 1265
Email address
vahedalainh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peppermint on improvement of GI function after Ceasarine section
Public title
Effect of peppermint on GI disorder after Ceasarine section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Woman undergone elective caesarian with Spinal Anesthesia in term 38-40 weeks; Monotone
Exclusion criteria: Having abdominal surgery; GI disease; Choleliathiasis and diabetes and Hyperion; usage of GI herbal or chemical drug; Diarrhia and vomiting and distention in the past 48 hours; opioid usage; sensitive to peppermint
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Patients joined the research and researcher do not know about the drug contant
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah St, Ghoreish Department .
City
Mashhad
Postal code
13944-91388
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.MUMS.fm.REC.1395.360
Health conditions studied
1
Description of health condition studied
GI DYSFUNCTION
ICD-10 code
K91.8
ICD-10 code description
Other postprocedural disorders of digestive system, not elsewhere classified
Primary outcomes
1
Description
Intestinal function
Timepoint
Before and 12 hours after intervention
Method of measurement
Physical Exam
2
Description
Breastfeeding
Timepoint
24 hours after operation
Method of measurement
Look and note
3
Description
Start Diet
Timepoint
24hours after operation
Method of measurement
Look and note
Secondary outcomes
1
Description
Abdominal Circumflex
Timepoint
Before and 12 and 24 hours after ceasarine
Method of measurement
Centimeter
Intervention groups
1
Description
Intervention group :20 drops of mint at 30 cc water and 3 times every 1 hour
Category
Treatment - Drugs
2
Description
Control group: 20 drops of placebo at 30 cc water and 3 times every 1 hour
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Hora Vahed
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mahyar Mirheidari
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St., Mashhad. Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad Medical University
Full name of responsible person
seyede hoora mosavi vahed
Position
Assistant professor
Other areas of specialty/work
Street address
Square TAGHIABAD, Imam Reza (AS) Hospital, Department of Obstetrics and Gynecology
City
Mashhad
Postal code
Phone
+98 51 3802 2608
Fax
Email
vahedalainh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Medical University
Full name of responsible person
Seyede Hoora Mosavi vahed
Position
Assisstant professor
Other areas of specialty/work
Street address
Square TAGHIABAD, Imam Reza (AS) Hospital, Department of Obstetrics and Gynecology
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
vahedalainh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Medical University
Full name of responsible person
Seyede Hoora Mosavi Vahed
Position
Associate professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
Vahedalainh @mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)