clinical effect of chamomile on hemorrhoid in lactating women
Design
Clinical trial with control group, with parallel groups, double blind, randomized
Settings and conduct
Participants are randomly assigned to the two groups of 35 recipients of Chamomile Ointment and placebo group.This study will be conducted in Comprehensive Health Centers of Hamadan city. In this study, neither the researcher nor the women knows the contents of the package and double blinded will be performed. In intervention group, Chamomile Ointment and in Control group, placebo will be prescribed Twice in a day along two weeks.
Participants/Inclusion and exclusion criteria
Criteria inclusion: Confirmation of diagnosis of grade 1 and 2 hemorrhoids; presence of hemorrhoid symptoms for 1 week; not using cigarette or alcohol;
not having physical or mental diseases; not using Anti-hemorrhoid drugs
Criteria exclusion: Drug intolerance
Intervention groups
Chamomile oil will be prescribed in the form of Ointment , Twice in a day along two weeks. This drug Will be produced by Hamadan University of Medical Sciences.
Main outcome variables
Itching; pain severity; Hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N6
Registration date:2020-03-10, 1398/12/20
Registration timing:prospective
Last update:2020-03-10, 1398/12/20
Update count:0
Registration date
2020-03-10, 1398/12/20
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on phytochemistry and clinical effect of chamomile on hemorrhoid in lactating women
Public title
clinical effect of chamomile on hemorrhoid in lactating women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of diagnosis of grade 1 and 2 hemorrhoids,
symptoms of hemorrhoids for 1 week
not using cigarette or alcohol
not having physical or mental diseases
not using anti-hemorrhoid drugs
Exclusion criteria:
Drug intolerance
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly selected by (randbetween (1; 2)) command, in the Excel computer program that are assigned to the two groups of 35 recipients of Chamomile Ointment and placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug packages are similar and were given to menopausal women by other person. This person does not inform about the package contents. therefore, neither the researcher nor the women knows the contents of the package and double blinding will be performed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2020-03-07, 1398/12/17
Ethics committee reference number
IR.UMSHA.REC.1398.1079
Health conditions studied
1
Description of health condition studied
Hemorrhoid
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
Itching
Timepoint
The first, seventh and fourteenth days
Method of measurement
Visual scale of hemorrhoids symptoms
2
Description
Pain severity
Timepoint
The first, seventh and fourteenth days
Method of measurement
Visual scale of hemorrhoids symptoms
3
Description
Hemorrhage
Timepoint
The first, seventh and fourteenth days
Method of measurement
Visual scale of hemorrhoids symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Chamomile Ointment will be prescribed in the form of Oral Capsule 500 mg, Twice in a day along two months. This drug Will be produced by Hamadan University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: placebo will be prescribed in the form of Eucerin based Twice in a day along two months. The placebo is made in Hamadan University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Service Center of Shohada
Full name of responsible person
Ensiyeh Jenabi
Street address
Comprehensive Health Service Center of Shohada., Takhti Ave., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838344
Phone
+98 81 3252 4321
Email
Shohada.health@yahoo.com
2
Recruitment center
Name of recruitment center
Comprehensive Health Service Center of Khezr
Full name of responsible person
Ensiyeh Jenabi
Street address
Comprehensive Health Service Center of Khezr., Khezr Ave., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838289
Phone
+98 81 3266 0550
Email
Khezr.Health@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Av
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
S_bashrian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data analysis is permitted with the author's permission.
From where data/document is obtainable
Hamadan University of Medical Sciences
What processes are involved for a request to access data/document