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The role of ranitidine in the prevention of olanzapine induced weight gain
Acronym :
IRCT registration number : Irct registration number : IRCT201009112181N5
Date registered : October 26, 2010
Registration timing : Retrospective registration
   
Recruitment status : Recruitment complete
Expected recruitment start date : 2008-03-20
Expected recruitment end date : 2009-03-21
   
Scientific title : The role of ranitidine in the prevention of olanzapine induced weight gain
Summary :

Olanzapine is an atypical antipsychotic drug which is widely used in psychiatric wards and has weight gain side effect. The aim of this study was to analyze the effect of ranitidine in prevention of olanzapine induced weight gain. It was a triple blind randomized clinical trial on the patients with thought disorder who was taking olanzapine. 60 patients entered the study considering the inclusion and exclusion criteria. Then, they were randomly assigned into intervention or comparison group. The intervention group was given 600 mg of ranitidine, daily made by Sobhan company along with olanzapine while the comparison group was given placebo with the same color, shape, and taste of ranitidine along with olanzapine for 16 weeks. Before and 16 weeks after intervention, the patients in both group weighted by weight scale (Kg) and ranitidine side effects were recorded weekly by drugs side effect questionnaire .

   
Public title : The role of ranitidine in the prevention of weight gain
Purpose : Prevention
Inclusion/exclusion criteria : Inclusion criteria: Taking olanzapine for thought disorder, Hospitalization for over 16 weeks, signing informed written consent Exclusion criteria: The physical co-morbidity, Simultaneous taking of drugs with weight gain side effect, Special diets
Minimum age : Year: 18         
Maximum age : Year: 150         
Gender : Both male and female
   
Health condition table is empty1 : obesity
Condition studied : E66.1
Condition ICD-10 code : Drug-induced obesity
   
Health condition table is empty2 : Schizophrenia
Condition studied : F20
Condition ICD-10 code : Schizophrenia
   
Health condition table is empty3 : Schizoaffective disorders
Condition studied : F25
Condition ICD-10 code : Schizoaffective disorders
   
Intervention/Control1 Intervention group: tab ranitidine 150mg, 4 tab per day, orally, for 16 weeks
Intervention category Treatment: drugs
Intervention/Control2 Control group: placebo with the same shape, size and taste, 4 tab, orally, for 16 weeks
Intervention category Placebo
   
Primary outcome measure1: body weight
Primary outcome time point Before and 16 weeks after intervention
Primary outcome method of measurement Weight Scale(kg)
   
Secondary outcome measure 1 : ranitidine side effects
Secondary outcome time point Weekly
Secondary outcome method of measurement drugs side effects questionnaire
Trial phase : N/A
Target sample size : 60
Randomization : randomized
Blinding : Triple blind
Placebo : used
Assignment : Parallel
Other design features :
   
Centre name 1 Tabriz Razi Hospital
Contact person's name Dr Fatemeh Ranjbar Kouchaksaraie
Country Iran, Islamic Republic Of
Contact details : Razi Hospital, El goli road, Tabriz
Tabriz
East Azarbaijan

00984113804486



   
Ethics committee name 1 Vice chancellor for research of Tabriz University of Medical Sciences
Date approved 13/8/2008
Reference number 3992/4/5
Contact details : Tabriz University of Medical Sciences, Golgasht streat, Tabriz
Tabriz
Easterly Azarbaijan
Iran, Islamic Republic Of
   
Sponsor 1 Tabriz University of Medical Sciences
Contact person's name Vice chancellor for research
Grant name 202/124
Grant code
Contact details : Tabriz University of Medical Sciences, Golgasht streat, Tabriz
Tabriz
East Azarbaijan
Iran, Islamic Republic Of

00984113344280 00984113357310



http://researchvice.tbzmed.ac.ir
   
Person responsible for general inquiries
Dr. Alireza Ghanepoor
Affiliated Organization name Tabriz University of Medical Sciences
Position/degree Psychiatrist
Contact details : Razi Hospital, El goli road, Tabriz
Tabriz
East Azarbaijan
Iran, Islamic Republic Of
00984113804486
00989143119632
dr.ghanepoor@gmail.com
   
Person responsible for scientific inquiries
Dr Fatemeh Ranjbar Kouchaksaraie
Affiliated Organization name Tabriz University of Medical Sciences
Position / degree Psychiatrist, Associate professor
Contact details : Razi Hospital, El goli road, Tabriz
Tabriz
East Azarbaijan
Iran, Islamic Republic Of
00984113804486
00989143134827
ranjbarf@tbzmed.ac.ir
   
Person responsible for updating data
Dr. Mahboob Asadlo
Affiliated Organization name Tabriz University of Medical Siences
Position / degree Psychiaty resident
Contact details : Razi Hospital, El goli road, Tabriz
Tabriz
East Azarbaijan
Iran, Islamic Republic Of
   
Registered by : Fatemeh  Ranjbar Kouchaksaraei
Tabriz University of Medical Sciences
Faculty of Medicine, Tabriz University of Medical Sciences
Tabriz
East azarbaijan
Iran, Islamic Republic Of
Phone: 00984113376923
Fax: 00984113344280
ranjbarf@tbzmed.ac.ir
   
   
Update 1 Date: January 13, 2012
Updated item: Person responsible for general inquiries
Previoius content: Dr Fatemeh Ranjbar Kouchaksaraie
Update 2 Date: January 10, 2012
Updated item: Person responsible for general inquiries / Contact details / Email
Previoius content: ranjbarf@tbzmed.ac.ir
Update 3 Date: January 10, 2012
Updated item: Person responsible for general inquiries / Contact details / Mobile phone
Previoius content: 00989143134827
Update 4 Date: January 10, 2012
Updated item: Person responsible for general inquiries / Position/degree
Previoius content: Psychiatrist, Associate professor