Protocol summary

Study aim
Comparison of The Effect of Purslane (Portulaca Oleracea) and Hollyhock Ointment on Pain and Episiotomy Wound Healing
Design
In this study, the target population is the Women will be admitted to obstetrics and gynecology wards of Imam Reza and Umm al-Binin hospitals in Mashhad. Sampling method is also simple random, The sample size is 90 patients. This is a phase 3 clinical trial.
Settings and conduct
The location of this intervention is Ommolbanin and Imam Reza Hospital city of Mashhad. In this study, each intervention group used as much as one knuckle (2cm) Purslane, hollyhock and placebo ointment on episiotomy wounds twice per day for 10 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Pregnancy term (37-42), Singleton, Age 18 to 35 years old, nulliparous, Not having a particular diet, Having reading and writing skills, BMI less than 29 and voluntary participation. Exclusion criteria included: Hematoma, Infection, Disorders in the stages of labor (prolongation of labor and dystocia), Neonatal need for regeneration, Episiotomy extension, High hemorrhage after delivery, Use Vacuum, Repeated manipulation of the perineum, Not having any particular disease (anemia, cardiovascular disease, diabetes, immunity, liver, depression), Smoking and alcohol and drugs and Unwillingness to participate
Intervention groups
The intervention groups consist of three groups: the first group include 30 women than receiving topical Purslane ointment and the second group include 30 women than received topical Hollyhock ointment and the third group is the control group.
Main outcome variables
Pain, wound healing episiotomy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190315043059N2
Registration date: 2019-08-01, 1398/05/10
Registration timing: prospective

Last update: 2019-08-01, 1398/05/10
Update count: 0
Registration date
2019-08-01, 1398/05/10
Registrant information
Name
Hamidreza Ebrahimisenu
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
ebrahimi.h.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Effect of Purslane (Portulaca Oleracea) and Hollyhock Ointment on Pain and Episiotomy Wound Healing
Public title
Comparison of The Effect of Purslane (Portulaca Oleracea) and Hollyhock on Episiotomy Healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy term (42-37) Singleton Age 18 to 35 years old nulliparous Not having a particular diet Having reading and writing skills BMI less than 29 voluntary participation
Exclusion criteria:
Hematoma Infection Disorders in the stages of labor (prolongation of labor and dystocia) Neonatal need for regeneration, Episiotomy extension High hemorrhage after delivery Use Vacuum Repeated manipulation of the perineum Not having any particular disease (anemia, cardiovascular disease, diabetes, immunity, liver, depression) Smoking and alcohol and drugs Unwillingness to participate
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Using the number cruncher statistical system (NCSS) software, the samples will randomly assign to one of the three groups of Purslane ,hollyhock and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients become blind because of the appearance and color of the ointment. Due to lack of knowledge about the random allocation of patients to the intervention 1 and 2 group, the researcher was blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691987888
Approval date
2019-07-24, 1398/05/02
Ethics committee reference number
IR.GMU.REC.1398.065

Health conditions studied

1

Description of health condition studied
Episiotomy
ICD-10 code
ICD-10 code description
Second degree perineal laceration during delivery

Primary outcomes

1

Description
Pain intensity of episiotomy
Timepoint
Before intervention, 12 hours, 5 and 10 days postpartum
Method of measurement
Visual Analouge Scale

2

Description
wound healing of episiotomy
Timepoint
before intervention, 12 hours, 5 and 10 days postpartum
Method of measurement
REEDA scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Purslane ointment is used as much as one knuckle (2cm) on episiotomy wounds twice per day for 10 days.
Category
Treatment - Drugs

2

Description
Intervention group: Hollyhock ointment is used as much as one knuckle (2cm) on episiotomy wounds twice per day for 10 days
Category
Treatment - Drugs

3

Description
Control group: placebo ointment is used as much as one knuckle (2cm) on episiotomy wounds twice per day for 10 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Mohaddese Abbaspour
Street address
Ayatolah Bahjat Street, Mashhad, Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1061
Email
Oah.it@mums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohaddese Abbaspour
Street address
the margin of Imam Reza Square, Ibn Sina Street, Mashhad, Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Imamrezahos@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Shahla Khosravan
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
mma_khosravan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Hamidreza Ebrahimisenu
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691933577
Phone
+98 51 5722 3028
Email
hamid.ebrahimi7050@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691933577
Phone
+98 51 5722 3028
Email
nasirzadeharnz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohsen Aliakbari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691933577
Phone
+98 51 5722 3028
Email
mohsenaliakbari1998@gmail.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
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