1. Aim
The comparative study of efficiency and safety of herbal anti hemorrhoid suppository of Myrtoid and conventional anti hemorrhoid suppository
2. Study design
Randomized, double blinded, without placebo, unicenter
3. Setting and conduct
After obtaining informed consent from patients and filling the questionnaire, hemorrhoid degree is determined during the first visit. Subsequently, patients are assigned in two study groups and one group receives Myrtoid anti hemorrhoid suppository whereas the other one receives the conventional anti hemorrhoid suppository. After two weeks, patients are examined for any changes in the degree of hemorrhoid symptoms and are given a score according to the severity of symptoms.
4. Study population
Inclusion criteria: All the visited patients with hemorrhoid symptoms and without the exclusion criteria
Exclusion criteria: External thrombosed hemorrhoid; Internal strangulated hemorrhoid; Anal fistula; Anal fissure; Anal abscess; Pregnancy; Portal hypertension; Type 3 and 4 hemorrhoids; Renal insufficiency; Malignancies
Sample size: 100
5. Interventions
Intervention group: Myrtoid anti hemorrhoid suppository, BID for two weeks
Control group: Conventional anti hemorrhoid suppository, BID for two weeks
6. Primary outcome measure: Bleeding; Pain during bowel movements; Heaviness in anus; Tenesmus; Constant pain in anus; Anal itching; Irritation in anus
Secondary outcome measure: Adverse effects
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506211165N7
Registration date:2015-10-22, 1394/07/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiatallah University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of efficiency and safety of herbal anti hemorrhoid suppository of Myrtoid and conventional anti hemorrhoid suppository
Public title
The effect of Myrtoid suppository in hemerrhoid treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All the visited patients with hemorrhoid symptoms who lack the exclusion criteria
Exclusion criteria:
External thrombosed hemorrhoid; Internal strangulated hemorrhoid; Anal fistula; Anal fissure; Anal abscess; Pregnancy; Portal hypertension; Type 3 and 4 hemorrhoids; Renal insufficiency; Malignancies
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baghiatallah University of Medical Sciences
Street address
Baghiatallah University of Medical Sciences, Molla Sadra St, Vanak Sq
City
Tehran
Postal code
Approval date
2015-08-19, 1394/05/28
Ethics committee reference number
IR.BMSU.REC.1394.68
Health conditions studied
1
Description of health condition studied
hemorrhoids
ICD-10 code
I84.9
ICD-10 code description
Unspecified haemorrhoids without complication
Primary outcomes
1
Description
bleeding
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
2
Description
Pain during bowel movements
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
3
Description
Constant pain in anus
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
4
Description
Heaviness in anus
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
5
Description
Tenesmus
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
6
Description
Anal itching
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
7
Description
Irritation in anus
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
adverse effects
Timepoint
during the treatment period
Method of measurement
clinical assessment
Intervention groups
1
Description
Intervention group: Myrtoid anti hemorrhoid suppository, BID for two weeks
Category
Treatment - Drugs
2
Description
Control group: conventional anti hemorrhoid suppository, BID for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiatallah Hospital
Full name of responsible person
Yunes Panahi
Street address
Research Center of Chemical Injuries, Baghiatallah University of Medical Sciences, Molla Sadra St, Vanak Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baghiatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Office of the Vice Chancellor for Research, Baghiatallah University of Medical Sciences, Molla Sadra St, Vanak Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Baghiatallah University of Medical Sciences
Full name of responsible person
Shahriar Payab
Position
Pharm. D
Other areas of specialty/work
Street address
Research Center of Chemical Injuries, Baghiatallah University of Medical Sciences, Molla Sadra St, Vanak Sq
City
Tehran
Postal code
Phone
+98 41 3444 0826
Fax
Email
sh.payab@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baghiatallah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Professor of pharmacotherapy
Other areas of specialty/work
Street address
Research Center of Chemical Injuries, Baghiatallah University of Medical Sciences, Molla Sadra St, Vanak Sq
City
Tehran
Postal code
Phone
+98 21 8248 2516
Fax
Email
yunespanahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)