The efficacy of herbal anti-hemorrhoid suppository containing essential oil of Myrtus Communis in reducing the severity of hemorrhoids and its complications
The comparative study of efficiency of herbal anti hemorrhoid suppository containing different doses of essential oil of Myrtus Communis and conventional anti hemorrhoid suppositor onType 1 and 2 hemorrhoids symptoms
Design
Randomized clinical trial, controlled with medicine, parallel, double blind, single central
Settings and conduct
This study is a clinical trial on 180 patients with Type1 and 2 hemorrhoids who do not need emergency surgery referred to research presenter office. Individuals based on table of random numbers will be divided to one of the groups received suppository containing 10% or 15% essential oil of Myrtus Communis or routine suppository BID for 2 weeks randomly . All drug are presented in the same package and the physician , patients, researcher and statistical analyst are blind .After analyzing data, codes will be decoded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All the visited patients with Type1 and 2 hemorrhoids who do not need emergency surgery referred to research presenter office.
Exclusion criteria: External thrombosed hemorrhoid; Internal strangulated hemorrhoid; Anal fistula; Anal fissure; Anal abscess; Pregnancy; Portal hypertension; Type 3 and 4 hemorrhoids; Renal insufficiency; Malignancies;pregnancy
Intervention groups
Intervention groups: herbal anti hemorrhoid suppository containing 10% , 15 %essential oil of Myrtus Communis , BID for two weeks.Control group: conventional anti hemorrhoid suppository, BID for two weeks
Main outcome variables
severity of hemorrhoid, bleeding, Pain during bowel movements
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012438N26
Registration date:2018-05-23, 1397/03/02
Registration timing:registered_while_recruiting
Last update:2018-05-23, 1397/03/02
Update count:0
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of herbal anti-hemorrhoid suppository containing essential oil of Myrtus Communis in reducing the severity of hemorrhoids and its complications
Public title
The efficacy of Myrtus Communis suppository on hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the visited patients with Type1 and 2 hemorrhoids who do not need emergency surgery referred to presenter office
Coding and similar packaging. The physician, patient, researcher and statistical analyzer are blind. At the end of the study and analysis of data, codes are decoded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2016-11-16, 1395/08/26
Ethics committee reference number
IR.KAUMS.REC.1395.85
Health conditions studied
1
Description of health condition studied
hemorrhoids
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
bleeding
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
2
Description
Pain during bowel movements
Timepoint
Before intervention, 2 weeks after initiation of intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: herbal anti hemorrhoid suppository containing 10% essential oil of Myrtus Communis, prepared in the formulation unit of Barij Essence Pharmaceutical Company , BID for two weeks
Category
Treatment - Drugs
2
Description
Intervention group: herbal anti hemorrhoid suppository containing15 %essential oil of Myrtus Communis, prepared in the formulation unit of Barij Essence Pharmaceutical Company , BID for two weeks
Category
Treatment - Drugs
3
Description
Control group:conventional anti hemorrhoid suppository, prepared in the formulation unit of Barij Essence Pharmaceutical Company, BID for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
research presenter office
Full name of responsible person
DR Mohammad Eidy
Street address
Vali Asr Medical Building, Shahid Beheshti St, Kashan
City
Kashan
Province
Isfehan
Postal code
009803155741040
Phone
+98 31 5574 1040
Email
m_eidy1356@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
1178
Phone
+98 86 4854 0000
Fax
+98 86 4436 2187
Email
info@barijessence.com
Web page address
http://www.barijessence.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan university of Medical Science, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
hamiidi@yahoo.com
Web page address
http://kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
50
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
Kashan University of Medical Sciences
Full name of responsible person
M.Taghizadeh
Position
phd
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
kashan university of medical sciences.kashan
City
Kashan
Province
Isfehan
Postal code
۸۷۱۵۹۸۸۱۴۱
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Eidy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Kashan university of Medical Science, Kashan
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5562 0608
Email
m_eidy1356@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Barij Essence Research Center of Medicinal Herbs
Full name of responsible person
Mahlouji Mahnaz
Position
Expert in clinical research
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
0864002
Phone
+98 86 4854 0000
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
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