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IRCT201612278170N10 IRCT 2017-08-07 Vice President of Research Tabriz University Of Medical Sciences effects of topical ointment Myrtus communis on symptoms of internal hemorrhoid grade one and two 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 2017-06-22 anticipated 54 Complete https://irct.ir/trial/8614 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 hemorrhoid. Intervention 1: Intervention group: ointment Myrtus communis, topical, every 12 hours for 4 weeks. Intervention 2: Control group: ointment anti-hemorrhoid, quite similar to ointment Myrtus communis, topical, every 12 hours for 4 weeks.
public Khadijeh Samady
School of Nursing and Midwifery, South Shariati Street, Tabriz
Tabriz Iran (Islamic Republic of) +98 21 6559 0571 samady.1375@gmail.com Tabriz University of Medical Sciences scientific Malakouti.Jamileh
School of Nursing and Midwifery, South Shariati Street, Tabriz
Tabriz Iran (Islamic Republic of) 66156-15733 +98 41 3479 6770 samady.1375@gmail.com University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 40 years Female K62.9 Disease of anus and rectum, unspecified Treatment - Drugs Treatment - Drugs Intervention group: ointment Myrtus communis, topical, every 12 hours for 4 weeks Control group: ointment anti-hemorrhoid, quite similar to ointment Myrtus communis, topical, every 12 hours for 4 weeks 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). Quality of life score. Timepoint: Before interventionŲŒ 4 and 8 weeks after intervention. Method of measurement: The World Health Organization Quality of Life questionnaire of 26 questions (WHOQOL-BREF). The frequency of side events incidence. Timepoint: During 8 weeks after intervention. Method of measurement: The side events check list. The patients satisfaction of received drug. Timepoint: 4 and 8 weeks after intervention. Method of measurement: The check list of satisfaction of received drug. Vice President of Research Tabriz University Of Medical Sciences Approved 2017-05-08 Ethics Committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology University of Medical Sciences, Golgasht Street, Azadi Street Tabriz Iran (Islamic Republic of)