Background and Aims: Human brucellosis remains the most common zoonotic disease(caused by facultative intracellular Gram-negative bacteria of the genus Brucella) worldwide. The first-line therapy for brucellosis is the combination of doxycycline, 100 mg bid. for 6 weeks with an aminoglycoside (preferably, streptomycin, 1 g/day intramuscularly for 2–3 weeks). The combination of rifampin (600–900 mg/day orally) and doxycycline for 6 weeks is suggested as the principal alternative therapy. Nausea and emesis are common side-effects of doxycycline. Ginger (zingiber officinale) is often advocated beneficial for nausea & vomiting treatment. As there was no report regarding the effects of ginger in treatment of nausea due to doxycycline the purpose of present study was to further evaluate the effectiveness of ginger in patients with this challenge.
Methods: In this clinical trial study 108 patients entered the study and randomly assigned into 2 groups. Patients in group 1 received capsules containing 500 mg ginger bid. and in group 2 received placebos during the first 10 days of the treatment period. After 4 days wash-out period we changed order. The severity and relief of symptoms before and after each period were evaluated by a visual scoring system. T-test and Chi2 were used for statistical analyses of possible differences.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206291836N5
Registration date:2012-07-16, 1391/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-16, 1391/04/26
Registrant information
Name
Seyed Mojtaba Sohrevardi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5001
Email address
smsohrevardi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
kerman university of medical sciences
Expected recruitment start date
2012-07-31, 1391/05/10
Expected recruitment end date
2012-10-31, 1391/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Zingiber officinale L. efficacy on reducing nausea & vomiting due to doxycycline for brucellosis treatment
Public title
Efficacy of Zingiber officinale L. on reducing nausea & vomiting due to doxycycline
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:brucellosis patient how take doxycyclin
exclusion: sever GI adverse effect
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commitee of kerman university of medical sciences
Street address
Research advisory of kmu, Blvd jomhouri eslami
City
Kerman
Postal code
Approval date
2012-06-17, 1391/03/28
Ethics committee reference number
91/64/k
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Nausea
Timepoint
BID
Method of measurement
Standard visual scale
2
Description
Vomiting
Timepoint
daily
Method of measurement
Number of vomiting based on patients declare
Secondary outcomes
1
Description
Ginger adverse effects
Timepoint
During the study period
Method of measurement
Patents declare based on quastionnaire
Intervention groups
1
Description
Intervention group take ginger capsule to prevent nausea and vomiting due to doxycyclin
Category
Treatment - Drugs
2
Description
Control group: starch capsule
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Clinic
Full name of responsible person
dr farhad sarafzade
Street address
kerman- tahmasbabad crossroad- besat clinic
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Kerman University of Medical Sciencesl
Full name of responsible person
Dr. Reza Malekpour Afshar
Street address
Tahmasb Abad Street, KMU bulding
City
Kerman
Grant name
گرنت پژوهشی
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Kerman University of Medical Sciencesl
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
Kerman University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Sohrevardi
Position
Assisstan Professor, Clinical Pharmacy specialist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Haft Bagh BLVD
City
Kerman
Postal code
7616913555
Phone
+98 34 1320 5001
Fax
+98 34 1320 5003
Email
smsohrevardi@yahoo.com smsohrevardi@kmu.ac.ir
Web page address
www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Sohrevardi
Position
Assistant Prof. of clinical pharmacy
Other areas of specialty/work
Street address
Faculty of pharmacy, Haft Bagh Blvd.
City
Kerman
Postal code
761691355
Phone
+98 34 1320 5001
Fax
+98 34 1320 5003
Email
smsohrevardi@kmu.ac.ir , smsohrevardi@yahoo.com
Web page address
kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Sohrevardi
Position
Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Haft Bagh Blvd.
City
Kerman
Postal code
7616913555
Phone
+98 34 1320 5001
Fax
+98 34 1320 5003
Email
smsohrevardi@yahoo.comsmsohrevardi@kmu.ac.ir
Web page address
www.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)