This is a double blinded placebo controlled clinical trial. 60 20-70 year old patients who had grade III or IV of hemorrhoid and had been operated (open hemorrhoidectomy) in Imam-Khomeini or Buali-Sina hospital of Sari were randomly divided into two groups. Patients in intervention group received Aloe Vera and controls received placebo cream. Exclusion criteria were grade I and II of hemorrhoied, other anorectal diseases, addiction to alcohol or opium, pregnancy, cirrhosis and sensitivity to Aloe Vera. Immediately after operation a gas immersed in Aloe Vera or placebo inserted on operation site. Twelve hours after surgery three grams of cream was inserted in anus area by the patient and then they repeated this method three times a day for two weeks. Patients were visited in five time points (12, 24, and 48 hours and 2, and 4 weeks after operation). The pain after operation and pain after defecation were measured using visual analogue scale. Wound healing and bleeding were also recorded in special forms as secondary outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711131627N1
Registration date:2009-05-23, 1388/03/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-23, 1388/03/02
Registrant information
Name
Fariborz Eshghi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 2033
Email address
feshghy@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health services
Expected recruitment start date
2008-12-30, 1387/10/10
Expected recruitment end date
2009-03-30, 1388/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Aloevera cream on reducing pain and wound healing after hemorrhoidectomy
Public title
Efficacy of Aloevera cream on reducing pain after surgery of removal of hemorrhoid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemorrhoid grade III,IV, age 20-70 years,
Exclusion criteria: Presence of anal fissure, Presence of any hemorrhoid or other anorectal diseases, substance abuse or alcohol consumption, pregnancy, presence of cirrhosis, hypersensitivity to Aloe Vera or any other drug.
Age
From 20 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Street address
Mazandaran University of Medical Sciences, Imam Sqare
City
Sari
Postal code
4815733971
Approval date
2009-01-05, 1387/10/16
Ethics committee reference number
122-87
Health conditions studied
1
Description of health condition studied
Haemorrhoid grade III,IV
ICD-10 code
I84.1
ICD-10 code description
Internal haemorrhoids with other complications
Primary outcomes
1
Description
local pain
Timepoint
Immediately, 12, 24, 48 hours, 2 and 4 weeks after surgery
Method of measurement
VAS
2
Description
pain after defecation
Timepoint
Before surgery and 24, 48 hours, 2 and 4 weeks after surgery
Method of measurement
VAS
Secondary outcomes
1
Description
bleeding after surgery
Timepoint
before surgery and 48 hours, 2 and 4 weeks after surgery
Method of measurement
obsevation and asking patient
2
Description
wound healing after surgery
Timepoint
2 and 4 weeks after surgery
Method of measurement
obsevation
Intervention groups
1
Description
Three grams of Aloe Vera on lesion of rectum immediately and twelve hours after surgery by researcher then patients used Aloe Vera three times a day for 14 days
Category
Treatment - Drugs
2
Description
Three grams of placebo cream on lesion of rectum immediately and twelve hours after surgery by researcher then patients used placebo three times a day for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-khomeini hospital
Full name of responsible person
Fariborz Eshghi
Street address
Imam-Khomeini hospital, Razi St.
City
Sari
2
Recruitment center
Name of recruitment center
Bouali Sina hospital
Full name of responsible person
Faribirz Eshghi
Street address
Buali Sina hospital, pasdaran Boulevard, Imam Sqare
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Fariborz Eshghi
Street address
Mazandaran University of Medical Sciences, Imam square
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 and Health Services
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 and Health services