Hemorrhoids define as enlargement and distal displacement of the normal anal cushions which manifest by pain and rectal bleeding associated with bowel movement. Excision hemorrhoidectomy is the most effective treatment for hemorrhoids with lowest rate of recurrence compared to other modalities. A major drawback of hemorrhoidectomy is postoperative pain.The aim of the present study is to investigate the effects of topical atorvastatine in reduction of postoperative pain relief and wound healing.Type of study:A prospective, double-blind, randomized, placebo controlled trial.Inclusion criteria:All 18-65 years old patients who had hemorrhoidectomy surgery.Exclusion criteria:Individuals who show hypersensitivity to the product or improve symptoms of myopathy, the patients with renal failure and those with increased ulcer size after using the product.Intervention 1: Topical atorvastatine (2%), twice daily for two months.Intervention 2: Placebo (topically), twice daily for two months. Outcomes: 1)Pain. Methods of measurement: Visual Analog Scale (VAS). 2)Itch. Method: D-5.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404013014N8
Registration date:2014-10-12, 1393/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-12, 1393/07/20
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of topical Atorvastatine (2%) with placebo for post-hemorrhoidectomy pain relief and wound healing
Public title
The effects of topical atorvastatine (2%) for post-hemorrhoidectomy pain relief and wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients who had hemorroidectomy surgery between 18-65 years old؛
Exclusion criteria:Patients with hypersensivity to atorvastatine ؛ and those who develop myopathy, renal falier or ulcer size
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Mazandaran University of Medical Sciences, Ethical Commitee
Street address
Vice chancellor of research , Moalem square
City
Sari
Postal code
Approval date
2014-04-22, 1393/02/02
Ethics committee reference number
49870
Health conditions studied
1
Description of health condition studied
Excisional hemorrhoidectomy
ICD-10 code
I84.5
ICD-10 code description
External haemorrhoids with other complications
Primary outcomes
1
Description
Pain
Timepoint
Each week for 2 weeks then each month for 2 month
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
1
Description
Itching
Timepoint
Once monthly for two month
Method of measurement
5D
Intervention groups
1
Description
Intervention1: Topical atorvastatine (2%) BID for two weeks. each dose 1cm.
Category
Treatment - Drugs
2
Description
Intervention 2: Placebo, BID for two weeks, each dose 1cm
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooba special clinic
Full name of responsible person
Maliheh Hamidian
Street address
Tooba special clinic, Khazar street, Sari, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr.Ahmad Enayati
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research and technology, Moallem square, Sari, Mazandaran, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences, Vice chancellor for research
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
Mazandaran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Maliheh Hamidian
Position
Pharmacy student
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 15 1311 0267
Fax
Email
maliheh.hamidian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinical pharmacy specialist,Faculty of pharmacy, Sari
Full name of responsible person
Dr.Shahram Ala
Position
Associated professor of clinical pharmacy
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
sh204ala@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of medical science
Full name of responsible person
Dr.Shahram Ala
Position
Associated professor of clinical pharmacy
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Ir
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
sh204ala@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)