Evalution of the effect of ointment containing extract of Persian honeylocust(GleditsiaCaspica) on clinical symptoms and quality of life in patients with hemorrhoids: A randomized clinical trial
The main aim of this study was to determine the effect of ointment containing herbal extract on clinical symptoms and quality of life in patients with hemorrhoids.
The specific objectives are: to determine the effect of herbal ointment on the pain and discomfort in the rectum, the severity and frequency of rectorrhagia, rectal itching, lactulose consumption and quality of life of patients, side effects and possible satisfaction.
Design
A randomized, blinded,and controlled clinical trial with a parallel group design of 60 patients with hemorrhoids.
Settings and conduct
Among the patients with hemorrhoids referred to the clinics of the educational center and the office, 60 eligible patients will be randomly and blindly divided into two groups receiving ointments containing plant extracts or placebo ointments. Participants, main researchers, data collectors and assessor will be kept blind. Patients will use one gram of herbal ointment or placebo with the applicator every 12 hours for 2 weeks.
Participants/Inclusion and exclusion criteria
Patients 18 to 65 years of age with hemorrhoids with bleeding or hemorrhoidal prolapse or pain or both or all together and no anorectal disease and thrombosis and gangrenous hemorrhoids
Intervention groups
Herbal or placebo ointment recipient
Main outcome variables
Primary outcome: pain and bleeding
Secondary outcome: pruritus, quality of life, complications, and satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220122053783N1
Registration date:2022-02-20, 1400/12/01
Registration timing:prospective
Last update:2022-02-20, 1400/12/01
Update count:0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
Arezoo Moini Jazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3353 4776
Email address
a.moini@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-21, 1400/12/02
Expected recruitment end date
2022-10-24, 1401/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalution of the effect of ointment containing extract of Persian honeylocust(GleditsiaCaspica) on clinical symptoms and quality of life in patients with hemorrhoids: A randomized clinical trial
Public title
Persian honeylocust ointment in hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 1-2 internal hemorrhoids
Age 18-65 years
Patients with bleeding or hemorrhoidal prolapse or pain or two or all together
Have a signed informed consent form to participate in the study
Exclusion criteria:
Anorectal diseases such as rectal prolapse, Fisher, fistula, perianal abscess
Thrombosis and gangrenous hemorrhoids
Uncontrolled cardiovascular disease
Cirrhosis
Inflammatory bowel disease (IBD)
Pregnancy and lactation
History of allergy to herbal medicines
Use analgesics less than a week ago
Use of anticoagulants less than a month ago
Use of steroid less than a month ago
Unwillingness to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to the intervention and control groups in a block method. The samples will be determined by random blocking method with 2 blocks and using the table of random numbers obtained from Random Allocation Software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research (Allocation Concealment). The sample allocation ratio will be 1:1 (Allocation 1: 1) and will be placed in two groups receiving ointment containing herbal extract or placebo ointment (Assignment). Then, the ointments will be delivered to the participants based on the obtained blocks and in the order of allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, the main researchers of the study, the physician, the data collector, and the outcome assessor will be kept blind. The ointments are packed in the same shape tubes and numbered from one to 60 and finally are delivered to the participants in order.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofArdabil University of Medical Sciences
Street address
Daneshgah st, Ardabil Complex Univesity
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.ARUMS.REC.1400.279
Health conditions studied
1
Description of health condition studied
Hemorrhoid
ICD-10 code
K64.8
ICD-10 code description
Other hemorrhoids
Primary outcomes
1
Description
Pain according to CORECTS questionnaire
Timepoint
At the first (before starting the study), end of the first and the second week
Method of measurement
Colo-Rectal Evaluation of Clinical Therapeutics Scale (CORECTS) questionnaire
2
Description
Rectorrhagia according to CORECTS questionnaire
Timepoint
At the fist (before starting the study), end of the first and the second week
Method of measurement
Colo-Rectal Evaluation of Clinical Therapeutics Scale (CORECTS) questionnaire
Secondary outcomes
1
Description
Itching according to CORECTS questionnaire
Timepoint
At the fist (before starting the study), end of the first and the second week
Method of measurement
Colo-Rectal Evaluation of Clinical Therapeutics Scale (CORECTS) questionnaire
2
Description
Quality of Life
Timepoint
At the fist (before starting the study), end of the first and the second week
Method of measurement
The World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) questionnaire
3
Description
Possible side effects of treatment
Timepoint
At the fist (before starting the study), end of the first and the second week
Method of measurement
Researcher-made questionnaire
4
Description
Satisfaction of treatment
Timepoint
At the fist (before starting the study), end of the first and the second week
Method of measurement
Researcher-made questionnaire (according to Visual Analogue Scale)
Intervention groups
1
Description
Intervention group: they will receive an ointment containing hydroalcoholic extract of Persian honeylocust (Gleditsia Caspica) 1 gram/two times a day using an applicator for 2 weeks. Ointments were prepared in Shafa Pajohan Sabz Company, Tabriz, Iran.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: they will receive an ointment containing eucerine 1 gram/two times a day using an applicator for 2 weeks. Ointments were prepared in Shafa Pajohan Sabz Company, Tabriz, Iran.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Fatemi Hospital
Full name of responsible person
Dr. Mirsalim Seyed Sadeghi
Street address
Sarein Station, Imam Khomeini St., not far from Shariati Square, Dr Fatemi Hospital
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
fatemi@arums.ac.ir
2
Recruitment center
Name of recruitment center
Clinic of Dr. Seyed Sadeghi
Full name of responsible person
Mir Salim Seyed Sadeghi
Street address
Sarcheshmeh Square, Toi Alley, Navid Doctors Building
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+98 45 3325 1519
Email
salim.seyedsadeghi95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Farhad Pourfarzi
Street address
Daneshgah st. Ardabil Complex Univesity
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
info@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shafa pajohan sabz Company, Tabriz, Iran
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Arezoo Moini Jazani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Daneshgah st. Ardabil Complex Univesity
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
dr.moeeni@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mirsalim Seyed Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sarein Station, Imam Khomeini St., not far from Shariati Square, Dr. Fatemi Hospital
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
salim.seyedsadeghi95@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Arezoo Moini Jazani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Daneshgah st. Ardabil Complex Univesity
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
dr.moeeni@yahoo.com
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