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Evaluation of the efficacy and safety of an innovative flavonoid lotion in patients with hemorrhoid; A Randomized Clinical Trial

Protocol summary

Study aim
In this study we aimed to produce a combination of olive oil and honey propolis in the form of lotions and assess its healing and side effects in comparison with routine treatment, anti-hemorrhoid ointment (containing hydrocortisone and lidocaine).
Design
Randomized controlled clinical trial, not blinded, phase 2-3 on100 patients. Excel software permutations formula was used to randomize the block sequences.
Settings and conduct
100 over 18 years patients, with second-degree hemorrhoids or above, who are referred to the colonoscopy ward of Baqiyatallah hospital will be included in the study. Patients in both groups will use the dosage of medication similarly (topical/rectal, twice daily for one month).
Participants/Inclusion and exclusion criteria
Inclusion: Patients with grade 2 or more hemorrhoid degree, diagnosed by colonoscopy. exclusion: Patients with inflammatory bowel disease, pregnancy, lactation, history of hemorrhoid surgery and other anorectal diseases such as anal fissures, anorectal malignancies, heavy bleeding, general instability, hemorrhoid complications or exacerbation of symptoms (such as bleeding and pain) and occurrence of drugs side effects are excluded from the study.
Intervention groups
The case group is treated with flavonoid lotion and the control group treated with anti-hemorrhoid ointment, twice daily for one month. Patients are followed weekly with history and physical examination
Main outcome variables
Therapeutic effect of flavonoid leucine The safety of the flavonoid leucine Comparison of flavonoid leucine function with anti-hemorrhoid ointment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210325050769N2
Registration date: 2021-12-27, 1400/10/06
Registration timing: retrospective

Last update: 2021-12-27, 1400/10/06
Update count: 0
Registration date
2021-12-27, 1400/10/06
Registrant information
Name
Mohammad Heiat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2072
Email address
mohamad.heiat@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
2020-04-20, 1399/02/01
Actual recruitment end date
2020-04-29, 1399/02/10
Trial completion date
2021-06-05, 1400/03/15
Scientific title
Evaluation of the efficacy and safety of an innovative flavonoid lotion in patients with hemorrhoid; A Randomized Clinical Trial
Public title
Evaluation of the effectiveness of flavonoid lotion in the treatment of hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 2 or higher hemorrhoids Age range 18-75 Lack of drug allergy to lotion Lack of confounding underlying disease such as diabetes Patient satisfaction
Exclusion criteria:
Patient dissatisfaction Higher or lower grades of disease Presence of drug allergy to plant Lotion Existence of confounding underlying disease such as diabetes
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 86
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the study, the block method is used with individual randomization unit and Excel software (to generate random block sequences). The printed blocks will be placed in a sealed envelope and the researcher will randomly pick up one of them and assign the patients to the intervention or control group.
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
Research Ethics Committees of Baqiyatallah Hospital
Street address
Vanak sq, Mollasadra street, Southern sheikhbahaei street
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.BMSU.BAQ.REC.1398.032

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
Hemorrhoid grade
Timepoint
weekly
Method of measurement
With history and physical examination

2

Description
Rectal bleeding
Timepoint
Weekly
Method of measurement
With history and physical examination

3

Description
Anal pain
Timepoint
Weekly
Method of measurement
With history and physical examination

4

Description
Incomplete defecation
Timepoint
Weekly
Method of measurement
With history and physical examination

5

Description
Anal irritation
Timepoint
Weekly
Method of measurement
With history and physical examination

6

Description
Anal discharge
Timepoint
weekly
Method of measurement
With history and physical examination

7

Description
Anal discomfort
Timepoint
Weekly
Method of measurement
With history and physical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this groups use the herbal lotion topically/rectal, twice a day for one month. Each 100 mg of produced flavonoid lotion has 70% flavonoid content (1/2 honey propolis, 1/2 olive oil) and 30% Excipient as underlying solvent.
Category
Treatment - Drugs

2

Description
Control group: Patients in this groups use the anti-hemorrhoid ointment topically/rectal, twice a day for one month. Iran Najo anti-hemorrhoid ointment is available routinely in pharmacies and each 100 grams of it contains hydrocortisone acetate (0.275 grams), lidocaine (5 grams), aluminum subacetate (3.5 grams) and zinc oxide (18 grams).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Sara Razdar
Street address
Vanak sq, Mollasadra street, Southern sheikhbahaei street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8861 2072
Email
Srazdar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Khedmat
Street address
Vanak sq, Mollasadra street, Southern sheikhbahaei street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8861 2072
Email
dr.khedmat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Sara Razdar
Position
Gastroenterologist and liver specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Vanak sq, Mollasadra street, Southern sheikhbahaei street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8861 2072
Email
Srazdar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Sara Razdar
Position
Gastroenterologist and liver specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Vanak sq, Mollasadra street, Southern sheikhbahaei street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8861 2072
Email
Srazdar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Heiat
Position
Research Manager of Baqiyatallah Research Center for Gastroenterology and Hepatology
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
Vanak sq, Mollasadra street, Southern sheikhbahaei street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8861 2072
Email
Mohamad.heiat@gmail.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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after un-identification of individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic centers as well as to industry professionals
Under which criteria data/document could be used
Statistical analyzes on data are allowed for scientific and research use after obtaining permission from the project manager
From where data/document is obtainable
For data and documentation, refer to the Research Center for Gastroenterology and Liver Diseases and Dr. Mohammad Heiat(Research Director of the Research Center)
What processes are involved for a request to access data/document
After receiving a written request from researchers working in academic and scientific institutions as well as people working in industry by the Baqiyatallah Research Center for Gastroenterology and Liver Disease and reviewing the application in the Research Council of the Research Center, the documents or data files will be delivered to the applicant after about 10 days.
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