To search for a safe and effective anti Giardiasis drug, we investigated the effect of Mebendazole and Praziquantel in comparison with Methronidazole. Study population consisted of patients with gastrointestinal complaints, including diarrhea, weight loss, anorexia or fatigue, referred to rural health care centers in Kohrang located in southwest of Iran where Giardiasis is high endemic. 600 people aged 2-30 years were subjected to stool examination using either wet smear or concentration methods in 2008. Parasite cyst or trophozoite were detected in 90 patients and they were considered positive for Giardiasis. All these patients were entered the study with informed consent of their parents or themselves and divided randomly into three groups. In first group, 30 cases were given Metronidazole in tablet or liquid form 20 mg/kg daily in three doses for 7 days. Second group were treated with Mebendazole in tablet form as single dose . Third group were given 20 mg/kg Praziquantle as single dose. To evaluate the effectiveness of the therapy, at least three stool samples from all cases were examined on the 7th , 10th and 14th days following completion of treatment by the same methods of primary stool examination and also by the same microscopists. Clinical symptoms of the patients were also recorded in each group before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708131431N1
Registration date:2011-10-05, 1390/07/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-05, 1390/07/13
Registrant information
Name
Reza Imani
Name of organization / entity
Shahrekord university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 0061
Email address
imani-r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord university of medical sciences
Expected recruitment start date
2008-05-01, 1387/02/12
Expected recruitment end date
2008-07-29, 1387/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Clinical Trial of Mebendazole, Praziquantel and Metronidazole in treatment of human Giardiasis
Public title
Treatment of Giardiasis with Praziquantel or Mebendazole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with gastrointestinal complaints including diarrhea; weight loss; anorexia or fatigue and positive for Giardaisis. Exclusion criteria: Drug side effects; Immune deficiency; consumption of current antibiotic.
Age
From 2 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shahrekord university of medical sciences
Street address
Shahrekord university of medical sciences, khashani avenue
City
Shahrekord
Postal code
8815713471
Approval date
2007-10-15, 1386/07/23
Ethics committee reference number
6-7-86
Health conditions studied
1
Description of health condition studied
giardiasis
ICD-10 code
A07.1
ICD-10 code description
Giardiasis [lambliasis]
Primary outcomes
1
Description
treatment of giardiasis
Timepoint
7-10 dayes after treatment
Method of measurement
stool examination
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: single- dose of Mebendazol 200mg.
Category
Treatment - Drugs
2
Description
Group 2: Metronidazole in tablet or liquid form 20 mg/kg daily in 3 doses for 7 days.
Category
Treatment - Drugs
3
Description
Group 3: 20mg/kg Praziquantle as single dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sharekord university of medical sciences
Full name of responsible person
Street address
City
Sharekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Dr. Mahmood Mobasheri
Street address
Shahrekord university of medical sciences, Kashani avenue
City
Sharekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord university of medical sciences
Full name of responsible person
Dr. Reza Imani
Position
spetialist
Other areas of specialty/work
Street address
Shahrekord university of medical sciences, Kashani avenue
City
Shahrekord
Postal code
Phone
+98 38 1333 0062
Fax
Email
rastabi669@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Dr. Reza Imani
Position
spetialist
Other areas of specialty/work
Street address
Shahrekord university of medical sciences, Kashni avenue
City
Shahrekord
Postal code
Phone
+98 38 1333 0062
Fax
Email
imanir46@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)