Evaluation of the effect of Terminalia chebula on the severity of hemorrhage
Design
A randomized, controlled, single-blind, placebo-controlled clinical trial
Settings and conduct
This study is a single-blind randomized clinical trial (which only patients do not know the type of drug) in 42 hemorrhoid patients referred to Sina Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: 1. Internal hemorrhoids 2. Patient hemorrhoids grade one, two and three 3. Having informed written consent to participate in the study
Exclusion criteria: Internal grade IV hemorrhoids 2. External hemorrhoids 3. Systemic disease 4. Anal fissure 5. Perineal abscess 6. Perianal fistula 7. Cirrhosis 8. Inflammatory bowel disease (IBD) 9.Those who have not received the full course of treatment or are experiencing medical complications.
Intervention groups
In the intervention group standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce itching of the anal area) is given with the ointment containing the active ingredient of Terminalia chubula.
The control group received standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce anal itching) with ointment containing fixed substance .
Main outcome variables
Severity of bleeding; Pain; Itching; Defecation discomfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190915044780N1
Registration date:2020-05-09, 1399/02/20
Registration timing:prospective
Last update:2020-05-09, 1399/02/20
Update count:0
Registration date
2020-05-09, 1399/02/20
Registrant information
Name
Abolfazl Bariklou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3285 2259
Email address
ab43477479@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Terminalia chebula Therapeutic effects in Patients With Symptomatic Hemorrhoids in reducing hemorrhage
Public title
Terminalia chebula Therapeutic effects in Patients With Symptomatic Hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Internal hemorrhoids
Patient hemorrhoids grade one, two and three
Having informed written consent to participate in the study
Exclusion criteria:
Internal Grade Four Hemorrhoids
external hemorrhoid
Systemic disease
anal fissure
anal abscess
anal fistula
cirrhosis
Inflammatory bowel disease (IBD)
Those who have not received the full course of treatment or are experiencing medical complications.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
In this method, we use simple randomization models, such as computer randomization methods, and place each patient in the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In addition to routine treatment, patients are given ointments that patients do not know about the type of ointment (which may contain the active ingredient of Terminalia chubula or just placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee School of Medicine- Tehran University of Medical Sciences
Street address
No. 23, 16 Azar Ave., Keshavarz Blvd.,Tehran
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2019-09-04, 1398/06/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.484
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
severity of hemorrhage
Timepoint
At the beginning of treatment and then weekly for 3 weeks
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce itching of the anal area) is given with the ointment containing the active ingredient of Terminalia chubula. The way to use the ointment is to put a teaspoon of ointment on your finger and apply it to the area of your anus. Do this twice a day for three weeks. All the steps of using the ointment will be fully explained to the patients. In this study we use a dose of 5% ointment of Terminalia chubula. The only difference in this study is to evaluate the efficacy of the plant only The pharmacokinetics and drug release rate will be evaluated in future studies.
Category
Treatment - Drugs
2
Description
Control group: The control group received standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce anal itching) with ointment containing fixed substance.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Hossein Zabihi Mahmoudabadi
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6675 7001
Email
hzabihim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6675 7001
Email
hzabihim@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Zabihi Mahmoudabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6675 7001
Email
hzabihim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
hossein zabihi mahmoudabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6675 7001
Email
hzabihim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Bariklou
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6675 7001
Email
ab43477479@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome, is shared.
When the data will become available and for how long
The access period begins 6 months after the results are published.
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used for further documentation and study. In the case of data analysis, the Person responsible for updating data
is responsible for delivering the data depending on the type of decision.
From where data/document is obtainable
To access the data, the persons can send an email message to the project manager.
dr zabihi
email: hzabihim@tums.ac.ir
What processes are involved for a request to access data/document
Depending on the type of application, the applicant arrives up to 2 months after the application has been submitted.