Comparison of the effect of topical ointment Myrtus Communis and anti-hemorrhoid on first and second grade hemorrhoid symptoms and the quality of life of women in post delivery period: a triple-blind controlled clinical trial
The purpose of this clinical trial, with two parallel arms triple blind is to determine the effects of topical ointment Myrtus communis on symptoms of internal hemorrhoid grade one and two in Women in the post delivery period referred to the clinic of Khatam al-Anbia Hospital in tehran. After obtaining written informed consent qualified subject to a randomized block design,eligible people with four and six blocks allocation ratio of 1:1 would be allocated in two group. ointment (construction Khoraman pharmaceutical company, containing of Myrtus communis ) and ointment anti-hemorrhoid quite similar to ointment Myrtus communis (RECTOL) by a uninvolved person in the sampling and data collection will be placed in a sealed opaque envelope with consecutive numbers. Ointments are identified for women aged 18-40 years old who have at least 4 weeks and a maximum of 4 months since their delivery, either naturally or as a surgical procedure (such as Nullipar and Multipar) and their hemorrhoids with clinical signs and approval by the general surgeon. It will not be caused by systemic diseases. Persons will intake prescription ointmentes daily (every 12 hours). The mean score of the symptoms of hemorrhoid in the designated visits and quality of life as a primary consequences will be assessed and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612278170N10
Registration date:2017-08-07, 1396/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Assistance of Research(Research and technology)Tabriz University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-20, 1396/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical ointment Myrtus Communis and anti-hemorrhoid on first and second grade hemorrhoid symptoms and the quality of life of women in post delivery period: a triple-blind controlled clinical trial
Public title
effects of topical ointment Myrtus communis on symptoms of internal hemorrhoid grade one and two
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women have given birth for at least 4 weeks and up to 4 months from their delivery, either in the normal way of any cesarean section (including Nully Par and Multipar); women in post delivery period who have been diagnosed their hemorrhoids first and second degree with clinical symptoms and confirmed by the Surgeon General; women between 18-40 years; Women in the postpartum period whose hemorrhoids are not caused by systemic diseases such as hypertension; hemorrhoid symptomsfor at least more than 7 days; The ability to read and write.
Exclusion criteria: Use of Systemic steroid Drugs and non-steroidal anti-inflammatory drugs and analgesics and anti-hemorrhoid treatments (for a one month prior to the study) and the use of anticoagulant drugs; require surgical procedure for the treatment of hemorrhoids (a gastroenterologist confirmed by clinical testing and colonoscopy); women with problems such as abscesses, anorectal, fistula, tuberculosis, herpes, varicella, fungal infection (confirmed by clinical trials or colonoscopy); risk of gastrointestinal tract infectious inflammatory diseases or colorectal cancer (as the patient); The previous use of laser or the use of medication felebotonic to treat hemorrhoids a week before the study (as the patient); Delivery with vacuums or forceps and delivery of cesarean section with large ancision; the company in another intervention study.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology University of Medical Sciences, Golgasht Street, Azadi Street
City
Tabriz
Postal code
Approval date
2017-05-08, 1396/02/18
Ethics committee reference number
IR.TBZMED.REC.1396.125
Health conditions studied
1
Description of health condition studied
hemorrhoid
ICD-10 code
K62.9
ICD-10 code description
Disease of anus and rectum, unspecified
Primary outcomes
1
Description
The mean score of the symptoms of hemorrhoids
Timepoint
Before intervention, 1, 2, 4 and 8 weeks after intervention
Method of measurement
(Colo-Rectal Evaluation of Clinical Therapeutics Scale) (CORECTS)
2
Description
Quality of life score
Timepoint
Before intervention، 4 and 8 weeks after intervention
Method of measurement
The World Health Organization Quality of Life questionnaire of 26 questions (WHOQOL-BREF)
Secondary outcomes
1
Description
The frequency of side events incidence
Timepoint
During 8 weeks after intervention
Method of measurement
The side events check list
2
Description
The patients satisfaction of received drug
Timepoint
4 and 8 weeks after intervention
Method of measurement
The check list of satisfaction of received drug
Intervention groups
1
Description
Intervention group: ointment Myrtus communis, topical, every 12 hours for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: ointment anti-hemorrhoid, quite similar to ointment Myrtus communis, topical, every 12 hours for 4 weeks