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" Safety and Efficacy of New Glyceryl trinitrate Suppository Formula: First Double Blind Placebo Controlled Clinical Trial "
/Samar Sayed Yahosein
; Mohammad Hasan Emami, Abolfazle Aslani
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Isfahan University of Medical Sciences
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| Document Type
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Latin Dissertation
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| Language of Document
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English
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| Record Number
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102640
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| Doc. No
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T10571
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| Call number
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WI,605,S274s,2007
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| Main Entry
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Sayed Yahosein, Samar
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| Title & Author
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Safety and Efficacy of New Glyceryl trinitrate Suppository Formula: First Double Blind Placebo Controlled Clinical Trial/Samar Sayed Yahosein
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| College
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Schools, Medical
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| Date
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, 2007
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| Degree
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Medicine, MD
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| Page No
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XI, 55 p.: diag, tab
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| Note
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This thesis is also a research project whit project ID 83367
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سمر سید یاحسین
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Orginal Works
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| Abstract
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Background: Anal fissure is a common condition currently affects 10 of patients attending proctology clinics. Aim: The aim of this study was to assess the safety and efficacy of the local application of 0.2 GTN suppository form in the healing of chronic anal fissure for the first time. Patients and methods:Thirty -four patients with symptomatic chronic anal fissures were randomly assigned to 0.2 GTN suppository (n=21) or Placebo (n=13).At first visit ethical consent was taken. Demographic data and patient's symptom scores were registered at first visit, then a validated daily chart was given to patients to assess their symptom on daily base.Patients received identical suppositories for six weeks twice daily. Both groups received Psylluim as stool softeners from the beginning of study and they were assessed at two week intervals for six weeks. Then they started a wash out period of one month and after that they were crossed for another six weeks. Results were analyzed with patients grouped according to initial randomization, and where applicable, chi-squared, t tests, and ANOVA for repeated measurement in cross over study were used for statistical analysis. A p value of less than 0.005 was regarded as indicating a significant difference. Results:Patients mean scores were significantly lower at the end of two weeks in both groups (p<0.05)).Complete healing at 6 weeks was achieved in 12 out of 2lpatients (57 ) in the GTN group and 5 out of 13 patients (38 ) in the Placebo (p<0.05). The overall healing rates at the end of study were 15out of 21 (71 ) vs 11 out of 13(84 ) in the GTN and Placebo groups respectively (p>0.05) During the study, 2 patients (9 ) developed side effects in the GTN group, compared with 1 patients (8 ) in the Placebo group (p>>0.05).We had one withdrawal in GTN group.Conclusions: Application of 0.2 GTN suppository form represents a new, promising, easily handled effective treatment for chronic anal fissure..
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| Descriptor
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Fissure in Ano
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Suppositories
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Safety
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Placebo Effect
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Hemorrhage
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Pain
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Nitroglycerin
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Patient Satisfaction
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| Added Entry
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Emami, Mohammad Hassan, Supervisor
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Aslani, Abolfazl, Supervisor
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