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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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)
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
1
-
Sponsor
-
-
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
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
-
There is no process for obtaining information
-
Comments
-