There are different methods of brucellosis treatment. One of them is doxycycline (6 weeks) rifampin (6 week) gentamicin (one week) that more than other treatment methods are used. With regard to the importance of the rifampin in the treatment of tuberculosis and high incidence of the brucellosis in the country and the central province and also prevalence of tuberculosis in iran it is better that use another drug instead of rifampin that have fewer side effects and better tolerance in brucellosis. In a double blind clinical traial study all patients with acute brucellosis that included to study are randomly divided in two groups. In group A treatment is Doxycyclin(6w)+Rifampin(6w)+gentamycin(1w) and in group B treatment is Doxycyclin(6w)+Garlet(6w)+Gentamicin(1w). The patient followed to improve clinical signs include fever, arthralgia, weakness and fatigue and a decrease in CRP ,Wright and 2ME titer to six months and compared in two groups. All patients information collected by questionnaire and finally the collected data analyzed by spss( version 19) software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305179855N4
Registration date:2013-06-02, 1392/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-02, 1392/03/12
Registrant information
Name
Aiasghar Farazi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 6526
Email address
dr.farazi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-15, 1392/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of garlic tablet in the treatment of brucellosis compared with rifampin
Public title
The effectiveness of garlic tablets in the treatment of brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with clinical symptoms of acute brucellosis;serologic test of wright at least 1:160 and 2ME of 1:40
exclusion criteria: age less than 8 years; the history of the two past years history of treatment of acute brucellosis; past history of chronic brucellosis; pregnant women; having inherent or acquired immunodeficiency; a history of sensitivity to garlic; Focale forms of brucellosis such as Spondylitis,endocarditis…
Age
From 8 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Sardasht, Arak University of Medical Sciences ,Arak
City
Arak
Postal code
Approval date
2012-10-08, 1391/07/17
Ethics committee reference number
91-134-4
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A49.9
ICD-10 code description
Bacterial infection, unspecified
Primary outcomes
1
Description
clinical sign and symptoms
Timepoint
Days of 0,7,21,42
Method of measurement
physical exam and Questionair
Secondary outcomes
1
Description
Decrease of WBC , ESR , CRP
Timepoint
Days of 0,7,21,42
Method of measurement
Check of WBC,ESR,CRP
2
Description
Decrease of Serologic test
Timepoint
Days of 0,7,21,42
Method of measurement
Check of wright and 2ME
Intervention groups
1
Description
In group A treatment is Doxycyclin(6w)+Rifampin(6w)+gentamycin(1w)
Category
Treatment - Drugs
2
Description
In group B treatment is Doxycyclin(6w)+Garlet(6w)+Gentamicin(1w)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital in Arak
Full name of responsible person
Aliasghar Farazi
Street address
Department of infectious diseases,valiasr hospital,Arak,Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Saed Changizi Ashtyani
Street address
Sardasht, Arak University of Medical Sciences ,Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ghazaleh Akbarifard
Position
Secretary of research Council
Other areas of specialty/work
Street address
Sardasht,Arak,Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
gakbarifard@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Infectious Diseases Specialist
Other areas of specialty/work
Street address
Department of infectious diseases , Vali asr hospital,Arak
City
Arak
Postal code
Phone
+98 86 1223 6855
Fax
Email
farazialiasghar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Infectious diseases specialist
Other areas of specialty/work
Street address
Department of infectious diseases,valiasr hospital,Arak,Iran
City
Arak
Postal code
Phone
00
Fax
Email
farazialiasghar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)