Evaluation of the efficacy of rectal preparation from Hemoheal® Cream on number of excretion daily and rate of rectal bleeding in patients with Hemorrhoid
The goal of this randomized double blind placebo controlled clinical trial is to prescribe a Hemoheal cream for patients with Hemorrhoid and evaluation of the efficacy of this natural remedy. Compounds of Hemoheal cream are a rectal preparation for hemorrhoid which includes aqueous extract of Allium schoenoprasum L, Commiphora Mukul and Sesamum Indicum L, are being prepared by a traditional pharmacy of the Traditional Medicine Clinic of the Faculty of Traditional Medicine of Tehran University of Medical Sciences. This study is done in Imam Reza hospital of Kermanshah University of Medical Sciences. 52 patients will be treated randomly with either Hemoheal cream (intervention) or placebo (control) twice a day for 30 days. Each time, 1 thin layer of cream is put on the stance. Major inclusion criteria include: age>18; patients who sign the testimonials and cooperate during the study and patients who were not cured with Hemoheal cream during the last month, and main exclusion criteria include: 4th-degree hemorrhoids; Pregnant patients and nursing mothers; Patients who have to use other drugs that interfere with this medication. Blinding is done for patients and physician who measure the outcome of the study. Randomization is performed using blocking method. Also, the number of excretion daily and rate of rectal bleeding are primary outcome measures, and gastrointestinal disorders are secondary outcome measure. Response to the medication, in patients under the treatment, will be evaluated based on hemorrhoid score (Disease Activity Index).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091335460N1
Registration date:2017-09-13, 1396/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-09-13, 1396/06/22
Registrant information
Name
Fateme Parvizi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 9220
Email address
fatemeparvizi4@gmail.com
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of rectal preparation from Hemoheal® Cream on number of excretion daily and rate of rectal bleeding in patients with Hemorrhoid
Public title
Evaluation of the efficacy of rectal preparation from Hemoheal® Cream in patients with Hemorrhoid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age>18; patients who sign the testimonials and cooperate during the study; patients who were not cured with Hemoheal cream during the last month; patients who their diseases are confirmed by complete medical evaluation including colonoscopy, pathology and laboratory data; only patients with mild to moderate hemorrhoids can be included in this study.
Exclusion criteria: 4th-degree hemorrhoids; pregnant patients and nursing mothers; patients who have to use other drugs that interference with this medication; patients who are suffering from other diseases in addition to hemorrhoids, such as apparent coagulation abnormalities or kidney impairment accompanied with colorectal diseases such as cancer, Crohn's disease, ulcerative colitis, anal fistula, anal fissure, proctitis or perineal skin inflammation; previous history of anorectal surgery; previous pelvic Electrotherapy or non-conservative treatment within the previous 6 months (rubber band ligation, infrared therapy and freeze therapy); patients who are disposed to a serious health danger, such as severe cardiac, liver or renal diseases; if significant side effects occur, the patient will be excluded from the study and followed to end of the study; patients with severe allergy to this plant (dermatitis contact) will be excluded.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is performed using blocking method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences
City
kermanshah
Postal code
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
KUMS.REC.1396.448
Health conditions studied
1
Description of health condition studied
Hemorrohiod
ICD-10 code
I84.8
ICD-10 code description
Unspecified haemorrhoids with other complications
Primary outcomes
1
Description
Number of excretion daily
Timepoint
Before using the drug; 2 weeks after using the drug-30 days after using the drugs
Method of measurement
Based on Hemorrohiod clinic questionary
2
Description
Rate of rectal bleeding
Timepoint
before using the drug; 2 weeks after using the drug-30 days after using the drugs
Method of measurement
based on Hemorrohiod clinic score
Secondary outcomes
1
Description
Gastrointestinal disorders
Timepoint
Two weeks after using the drug; 30 days after using the drug
Method of measurement
Based on side effect questionary
Intervention groups
1
Description
Intervention: Topical use of thin-layer Hemoheal cream twice a day for a month
Category
Treatment - Drugs
2
Description
Control: Topical use of thin-layer eucerin base cream twice a day for a month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mohammad Hosein Farzaei
Street address
Imam Reza Hospital, Parastar Blvd., Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohamad hosein Farzaee
Street address
Kermanshah University of Medical Sciences, Faculty of pharmacy,Daneshgah Ave., Shahid Shiroodi Blv., Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Parvizi
Position
Investigator of Kermanshah University of Medical Sciences
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Daneshgah St., Sorkheligheh, Kermanshah
City
Kermanshah
Postal code
Phone
00
Fax
Email
parvizi_70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosein Farzaei
Position
Associate Professor/ PhD of Traditional Medicine
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Faculty of pharmacy, Daneshgah Ave., Shahid Shiroodi Blv., Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3426 6780
Fax
Email
mh-farzaee@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Parvizi
Position
Investigator of Kermanshah University of Medical Sciences
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Daneshgah St., Sorkheligheh, Kermanshah
City
Kermanshah
Postal code
Phone
00
Fax
Email
parvizi_70@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)