Purpose of study: evaluation of Allium ampeloprasum cream efficacy for the management of hemorrhoids
study design:Double blind randomized placebo-control trial, uni-central
Study population:
Participants having symptomatic hemorrhoids attending Shiraz University of Medical Sciences clinics
Inclusion criteria:
Patients with symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination
Exclusion criteria:
Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer
Sample size:
75 patients (tree groups)
Interventions:
Topical Allium ampeloprasum cream/ placebo cream/anti-hemorrhoid cream
Time period:
3 week
Outcome measures:
pain,itching, bleeding, defecate discomfort, total improvement, constipation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010816143N1
Registration date:2014-09-29, 1393/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Seyed Hamdollah Mosavat
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 7589
Email address
mosavath@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for Traditional Medicine and History of Medicine Shiraz University of Medical Sciences
Expected recruitment start date
2014-09-24, 1393/07/02
Expected recruitment end date
2014-11-23, 1393/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind randomized placebo-control trial of Allium ampeloprasum cream effect for the management of hemorrhoids symptoms
Public title
Evaluation of Allium ampeloprasum cream effect for the management of hemorrhoids symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
1- Age: 18 Years to 65 Years
2- Participants who agree to participate in the current study
3- Participants having symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination
4- Participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period.
exclusion criteria:
1- Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer
2- Participants having hypersensitive predisposition or hypersensitive to Allium ampeloprasum or history of skin hypersensivity
3- Female participants under pregnancy or during breastfeeding period
4- Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or neurologic disorders or ascitis
g- history of steroid or anticoagulant drug consumption
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences, Zand street.
City
Shiraz
Postal code
Approval date
2014-08-24, 1393/06/02
Ethics committee reference number
CT-9377-7127
Health conditions studied
1
Description of health condition studied
hemorrhoids
ICD-10 code
I84.8
ICD-10 code description
Unspecified haemorrhoids with other complications
Primary outcomes
1
Description
pain
Timepoint
3 weeks after intervention
Method of measurement
visual analogue scale
2
Description
bleeding
Timepoint
3 weeks after intervention
Method of measurement
questionare
3
Description
itching
Timepoint
3 weeks after intervention
Method of measurement
questionare
4
Description
deficate discomfort
Timepoint
3 weeks after intervention
Method of measurement
visual analogue scale
5
Description
total improvment
Timepoint
3 weeks after intervention
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
constipation
Timepoint
3 weeks after intervention
Method of measurement
questionare
Intervention groups
1
Description
Allium Ampleoprasum topical cream 1 cc twice daily for 3 weeks for intervention group
Category
Treatment - Drugs
2
Description
placebo topical cream 1 cc twice daily for 3 weeks for control group
Category
Treatment - Drugs
3
Description
Anti hemorrhoid topical cream 1 cc twice daily for 3 weeks for standard treatment group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari polyclinic
Full name of responsible person
Seyed Hamdollah Mosavat
Street address
nemazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Haatam
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Zand Street.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Hamdollah Mosavat
Position
MD, PhD Candidate of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Imam Hossein Square, Zand Street
City
Shiraz
Postal code
Phone
+98 71 1234 8550
Fax
Email
hamdi_88114@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal research center of Shiraz University of Medical Sciences
Full name of responsible person
Dr.Leila Ghahramani
Position
general surgun, felloship of colorectal
Other areas of specialty/work
Street address
Faghihi hospital, Colorectal clinic
City
Shiraz
Postal code
Phone
+98 71 3235 1087
Fax
Email
leila_ghahramani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Hamdollah Mosavat
Position
MD, PhD Candidate of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Imam Hossein Square, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3234 8550
Fax
Email
hamdi_88114@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)