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The effect of Coconut oil ointment on the symptoms of Hemorrhoids in pregnant women

Protocol summary

Study aim
Determine the effect of Coconut oil ointment on Hemorrhoids symptoms in pregnant women
Design
Phase III parallel Clinical trial with Control group, No Blindness, Randomized allocation classified according to the gestational age , On 62 eligible pregnant women
Settings and conduct
The research units referring to Mashhad comprehensive health centers were selected using easy method and with randomized allocation classified according to the gestational age, they will be divided into intervention and control groups. Patients will be examined for symptoms in the 1, 7 and 14 days. If none of the symptoms of hemorrhoids recover within a week, they will be excluded from the study and will be referred to the specialist for further investigation, if recovery is observed in symptoms, treatment continues for another week, and if treatment is complete within one week, treatment will end
Participants/Inclusion and exclusion criteria
Reading and writing literacy, Women 15 to 45 years of age with Single-crowned pregnancy, Gestational age 14 to 36 weeks, having grade 1 or 2 Hemorrhoids, No history of colorectal cancer in person or their first degree relatives, Absence of systemic diseases obstetrics problems and other colorectal diseases, Absence of psychiatric problems and Occurrence an unpleasant incident in the last quarter, Non-use of Tobacco, Not having Depression Anxiety or severe Stress
Intervention groups
In Intervention group, in addition to giving advice on lifestyle modifications according to the country's guidelines, 50% coconut oil ointment with Vaseline base will be used as a full Applicator twice daily for 14 days. To the control group will give advice on lifestyle modifications according to the country's guidelines
Main outcome variables
The mean score of Hemorrhoid symptoms including Pain, Bleeding, Itching and Prolapse

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181204041842N1
Registration date: 2019-01-17, 1397/10/27
Registration timing: prospective

Last update: 2019-01-17, 1397/10/27
Update count: 0
Registration date
2019-01-17, 1397/10/27
Registrant information
Name
Elahe Jesmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 4278
Email address
jesmanie961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-12, 1397/11/23
Expected recruitment end date
2019-09-14, 1398/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Coconut oil ointment on the symptoms of Hemorrhoids in pregnant women
Public title
The effect of Coconut oil ointment on pregnancy Hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing literacy Pregnant women 15 to 45 years of age Gestational age 14 to 36 weeks Single-crowned pregnancy Confirmation of grade one or two Hemorrhoids diagnosis by female Doctor center and Researcher The presence of symptoms of Hemorrhoids for at least seven days
Exclusion criteria:
Use of Anti-Hemorrhoid drugs at present History of Colorectal cancer in person or their first degree relatives Having other Colorectal diseases Having of Systemic diseases The presence of Obstetrics problems The presence of Psychiatric problems Occurrence of an unpleasant incident in the last quarter Use of Drugs or other smoking Having Depression, Anxiety or severe Stress
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals using Stratified Random allocation for gestational age, by Randomization site into two equal and identical groups for Gestational age (Intervention and Control) are Allocated
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
Assistance of Research and Technology of Mashhad University of Medical Sciences, Qureishi building, Daneshgah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.064

Health conditions studied

1

Description of health condition studied
Hemorrhoids in pregnancy
ICD-10 code
O22.4
ICD-10 code description
Haemorrhoids in pregnancy

Primary outcomes

1

Description
Hemorrhoid pain score
Timepoint
The beginning of the intervention, 7th and 14th days after intervention
Method of measurement
Visual Analogue Scale of the Hemorrhoids symptoms

2

Description
Hemorrhoid bleeding score
Timepoint
The beginning of the intervention, 7th and 14th days after intervention
Method of measurement
Visual Analogue Scale of the Hemorrhoids symptoms

3

Description
Hemorrhoid itching score
Timepoint
The beginning of the intervention, 7th and 14th days after intervention
Method of measurement
Visual Analogue Scale of the Hemorrhoids symptoms

4

Description
Hemorrhoid prolapse score
Timepoint
The beginning of the intervention, 7th and 14th days after intervention
Method of measurement
Visual Analogue Scale of the Hemorrhoids symptoms

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to giving advice on lifestyle modifications according to the country's guidelines, 50% coconut oil ointment with Vaseline base will be used as a full Applicator twice daily for 14 days
Category
Treatment - Drugs

2

Description
Control group: To the control group will give advice on lifestyle modifications according to the country's guidelines
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Health Center No. 1
Full name of responsible person
Dr. Naser Amini
Street address
Between Vakil Abad 66 and 68, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9179793945
Phone
+98 51 3501 5080
Email
AminiN1@mums.ac.ir

2

Recruitment center
Name of recruitment center
Mashhad Health Center No. 2
Full name of responsible person
Dr. Ali Asghar Mahmoudi
Street address
Near to Vahdat Park, Vahdat Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9153913153
Phone
+98 51 3365 1652
Email
MahmoudiAA1@mums.ac.ir

3

Recruitment center
Name of recruitment center
Mashhad Health Center No. 3
Full name of responsible person
Dr. Brat Ali Arabnejad
Street address
Payam St, Ershad 8, Khayyam Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3763 4007
Email
ArabnejadBA1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Assistance of Research and Technology of Mashhad University of Medical Sciences, Qureishi building, Daneshgah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Email
Tafaghodim@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
Elahe Jesmani
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doktora Crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
91889-93684
Phone
+98 51 3893 4278
Fax
Email
JesmaniE961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samira Ebrahimzadeh Zagami
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery, School of Nursing and Midwifery, Ibn Sina Street, Doktora Crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
EbrahimzadehZS@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Jesmani
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doktora Crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
91889-93684
Phone
+98 51 3893 4278
Fax
Email
JesmaniE961@mums.ac.ir

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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