In a single blind randomized clinical trial all patients referred to outpatient clinics of Valiasr hospital and Emamreza with clinical symptoms and signs of brucellosis according to inclusion and exclusion criteria enrolled to study. Patients eligible for the study after obtaining informed consent were allocated randomly to one of three intervention groups: (A) 55 patients treated with doxycycline (Manufacture of Razak pharmaceutical Company) 200 mg (6 weeks), Rifampin (Manufacture of Alhavy pharmaceutical Company) 600 mg (6 weeks) and Gentamicin (Manufacture of Caspian pharmaceutical Company) 5 mg/kg per day (1 week) B: 55 patients treated with doxycycline 200 mg daily (6 weeks), rifampin 600 mg daily (6 weeks) plus ginseng (Manufacture of Goldaru pharmaceutical Company) 500 mg once daily (1 week) c: 55 patients were treated with doxycycline 200 mg daily (6 weeks) and rifampin 600 mg daily (6 weeks) are given. The patient's clinical response or treatment failure for 6 weeks and for relapse to 6 months after completion of treatment are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412219855N8
Registration date:2015-01-10, 1393/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-10, 1393/10/20
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
2014-10-01, 1393/07/09
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of ginseng compared with gentamicin in the improvement of symptoms in patients with brucellosis
Public title
The effect of ginseng in the treatment of brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 15 years; Wright titer at least 1/160 and 2ME 1/40; informed consent to participate in the study
Exclusion criteria: history of brucellosis in the past 2 years; history of chronic brucellosis; pregnant women; having innate or acquired immunodeficiency; history of allergy to ginseng; local forms of brucellosis infection such as endocarditis, spondylitis, etc.; patients with advanced or chronic disease of heart, lung, liver and kidney
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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, Vice Chancellor for Research
City
Arak
Postal code
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
93-168-4
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Disappearance of fever
Timepoint
Days of 0, 3, 5, 7, 14, 21
Method of measurement
With thermometer
2
Description
Resolve of arthralgia
Timepoint
Days of 0, 3, 5, 7, 14, 21
Method of measurement
Questionnaire
3
Description
Constitutional symptoms
Timepoint
Days of 0, 3, 5, 7, 14, 21
Method of measurement
Questionnaire
4
Description
Decrease of CRP
Timepoint
Days of 0,7, 14, 21, 28, 42
Method of measurement
Latex agglutination test
Secondary outcomes
1
Description
Treatment Failure
Timepoint
End of 6 weeks treatment
Method of measurement
No improvement in clinical symptoms and laboratory tests
2
Description
Relapse
Timepoint
Months of 3, 4, 5, 6, 7, 8
Method of measurement
ecurrence of clinical symptoms and laboratory tests
Intervention groups
1
Description
Intervention group 1: doxycycline 200 mg capsules daily (6 weeks) plus rifampin 600 mg capsules daily (6 weeks) plus Ginseng capsules 500 mg daily (1 week)
Category
Treatment - Drugs
2
Description
Intervention group 2 capsules doxycycline 200 mg (6 weeks) plus rifampin 600 mg once daily (6 weeks) plus gentamicin 5 mg/kg per day (1 week)