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General information
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49
49
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2020-04-01, 1399/01/13
2020-04-01 00:00:00
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2021-07-01, 1400/04/10
2021-07-01 00:00:00
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2021-09-05, 1400/06/14
2021-09-05 00:00:00
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We need to update the recruitment start and finish dates
We need to update the recruitment start and finish dates
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لازم است تاریخ آغاز و پایان بیمارگیری به روز شود.
لازم است تاریخ آغاز و پایان بیمارگیری به روز شود.
Recruitment centers
#1
Name of recruitment center - English: Emam Reza clinic Shiraz University of medical sciences
Name of recruitment center - Persian: درمانگاه امام رضا (ع) دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Mohammad Ebrahim Zohalinezhad
Full name of responsible person - Persian: محمد ابراهیم زحلی نژاد
Street address - English: Namazi Sq.
Street address - Persian: میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 714737-71348
Phone: +98 71 3647 4673
Fax:
Email: zohalinm@sums.ac.ir
Web page address:
Name of recruitment center - English: Emam Reza clinic, Shiraz University of Medical Sciences
Name of recruitment center - Persian: درمانگاه امام رضا (ع) دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Mohammad Ebrahim Zohalinezhad
Full name of responsible person - Persian: محمد ابراهیم زحلی نژاد
Street address - English: Namazi Sq.
Street address - Persian: میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134871473
Phone: +98 71 3647 4673
Fax:
Email: zohalinm@sums.ac.ir
Web page address:
Name of recruitment center - English: Emam Reza clinic, Shiraz University of medical sciencesMedical Sciences Name of recruitment center - Persian: درمانگاه امام رضا (ع) دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Mohammad Ebrahim Zohalinezhad Full name of responsible person - Persian: محمد ابراهیم زحلی نژاد Street address - English: Namazi Sq. Street address - Persian: میدان نمازی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 714737-713487134871473 Phone: +98 71 3647 4673 Fax: Email: zohalinm@sums.ac.ir Web page address:
Protocol summary
Study aim
Determination of herbal anti hemorrhoid cream on hemorrhoid and comparing with a conventional ointment
Design
The study is a phase-3 controlled trial. There are two groups: Intervention and control. The sample size is 80 patients. The randomization method is a block design.
Settings and conduct
The study is performed in Emam Reza clinic, Shiraz University of Medical Sciences. On admission, after filling out the consent form, the patients will be visited by a gastroenterologist. Thereafter, proctoscopy will be done for each patient to detect any probable risky process and determine the degree of hemorrhoid. Then, the demographic form and diagnostic hemorrhoid checklist will be filled out for all patients.
The drug and control, using for 14 days, are the same in the shape of the tube, package, and color of containing material.
The study is double-blind, so the physician and patient remain blinded.
After hand-washing, the tube content is used in the anal region using a special applicator one gram twice daily.
In the 2nd visit, the patient will be asked to stop medication use for 28 days. In this period, the conventional anti hemorrhoid ointment will be rendered to all patients to use only when needed. The number of uses should be recorded by the patients. After 28 days the patients will come to the clinic for the final evaluation and filling out the checklist.
Participants/Inclusion and exclusion criteria
Inclusion:
1- Age 18 y/o and more
2- Hemorrhoid grade: 1 or 2
Non-inclusion:
3- Malignancy
4- Hypertension
5- Hepatic or renal failure
6- Diabetes mellitus
Intervention groups
Intervention group: Herbal cream, 1 gram, locally on the anal region, twice daily, for 14 days.
Control group: Conventional anti hemorrhoid ointment, 1 gram, locally on the anal region, twice daily, for 14 days.
Main outcome variables
Hemorrhoid manifestations
General information
Reason for update
We need to update the recruitment start and finish dates
Acronym
IRCT registration information
IRCT registration number:IRCT20141011019489N3
Registration date:2020-04-20, 1399/02/01
Registration timing:registered_while_recruiting
Last update:2024-09-26, 1403/07/05
Update count:1
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
Meysam Shirzad
Name of organization / entity
School of traditional medicine, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4535
Email address
shirzad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
2020-04-01, 1399/01/13
Actual recruitment end date
2021-07-01, 1400/04/10
Trial completion date
2021-09-05, 1400/06/14
Scientific title
Effect of a natural cream on hemorrhoids in comparison with conventional anti-hemorrhoid ointment: A double-blind controlled trial
Public title
Effect of a natural cream on hemorrhoids in comparison with the conventional ointment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 and more
Hemorrhoid Grade 1,2
Exclusion criteria:
Any types of malignancy
Hypertension
Hepatic or renal failure
Diabetes mellitus
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
49
Randomization (investigator's opinion)
Randomized
Randomization description
We use two variables to remove the effect of confounding factors: age and weight. In this method, the effect of the abovementioned two variables is controlled via analysis of variance. So, the effect of the independent variable (drug) on the dependent variable will be determined.
To control age and weight we use randomized block design, i.e. quadratic blocks for weight and binary blocks for age. According to that, the samples will be allocated into A and B groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main researcher does not have any contact with the participants.
The gastroenterologist only visits the participants and fills out the checklists. So, he will be kept unaware of the allocation into A or B groups.
Moreover, the participants and the pharmacy technician who renders the ointments do not recognize the tubes (A or B) belonging to which group (drug or control). All tubes are the same form.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
6th Floor, Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.SUMS.MED.REC.1398.034
Health conditions studied
1
Description of health condition studied
Hemorrhoid
ICD-10 code
K64.0
ICD-10 code description
First degree hemorrhoids
2
Description of health condition studied
Hemorrhoid
ICD-10 code
K64.1
ICD-10 code description
Second degree hemorrhoids
Primary outcomes
1
Description
Manifestations of hemorrhoid
Timepoint
The onset of the intervention, 2 weeks later, 6 weeks later
Method of measurement
A checklist for hemorrhoid manifestations including 1- Anal pain (VAS zero to 10) 2- Difficulty in defecation (VAS zero to 10) 3- Bleeding severity (4-point Likert) 4- Anal pruritus (4-point Likert) 5- Anal burning (4-point Likert) 6- Subjective general improvement (percent)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal cream containing the extract of oleaster, wild leek and camomile, and the essence of common myrtle. Route of administration and dose: Locally one gram on the anal region by a special applicator twice daily for 14 days. Manufacturer: Barij Essence Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Control group: Anti-hemorrhoid ointment (containing lidocaine 5 grams+Hydrocortisone Acetate 0.275 grams+ Aluminium sub-acetate 3.5 grams+ Zinc oxide 18 grams%). Route of administration: Locally on the anal region by a special applicator twice daily for 14 days. Manufacturer: Aburaihan Pharmaceutical Company/Barij Essence Pharmaceutical Company. An edible green color is used for the placebo to change the color similar to the drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic, Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ebrahim Zohalinezhad
Street address
Namazi Sq.
City
Shiraz
Province
Fars
Postal code
7134871473
Phone
+98 71 3647 4673
Email
zohalinm@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrzad Lotfi
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Barij essence pharmaceutical company
Proportion provided by this source
100
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ebrahim Zohalinezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3208 4241
Email
zohalinm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meysam Shirzad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 25 Sarparast Ave., Taleqani St.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 3656
Email
shirzad@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ebrahim Zohalinezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3208 4241
Email
zohalinm@sums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The publication of data is restricted on demographic information and values obtained from the diagnostic checklist for hemorrhoids. This data will be published unrecognizably in the form of scientific articles in authentic journals.
When the data will become available and for how long
From March 2021 to March 2022
To whom data/document is available
All audiences
Under which criteria data/document could be used
The data can be used for similar researches under the prohibition of plagiarism
From where data/document is obtainable
The data is available online for all audiences
What processes are involved for a request to access data/document