Protocol summary

Summary
Ivermectin effect in treatment of patients with fascioliasis , Ivermectin is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins( a class of highly active broad-spectrum) . Ivermectin is a mixture containing at least 90% 5-O-demethyl-22,23-dihydroavermectin and less than 10% 5-O-demethyl-25-de(1-methylpropyl)- 22,23-dihydro-25-(1-methylethyl)avermectin , generally referred to as 22,23-dihydroavermectin . Its peak plasma concentration is 46 nanograms per mL after a single 12-mg dose . Ivermectin is metabolized by the liver and is excreted in the feces over an estimated period of 12 days, with less than 1% of the dose excreted in the urine. Ivermectin binds selectively and with high affinity to glutamate-gated chloride ion channels in invertebrate muscle and nerve cells of the microfilaria. This binding causes an increase in the permeability of the cell membrane to chloride ions and results in hyperpolarization of the cell, leading to paralysis and death of the parasite. It's an experimental , open lable and pilot study . It's studied on patients with Fasciola in the first six months of 1390 until the number reaches to 40 patients. In this period all people over 18 years old with Fasciola symptoms include: fever, sweating, weakness, fatigue, cough, pain in RUQ, epigastric pain, nausea, vomiting, skin rashes, skin lesions, muscle pain, Jaundice, weight loss associated with positive laboratory tests include: ELISA (+)and hypereosinophilia in CBCdiff and the lack of exclusion criteria included: pregnancy, lactation, hypersensitivity to the drug come to Anzali Health Care and they are reffered for treatment to Gastrointestinal and Liver Diseases Research Center(GLDRC) in Guilan province Rasht city. In GLDRC after obtaining consent from a patient ,questionnaire included: personal data, previous history of Fasciola treatment, symptoms before treatment, tests (S / E, ELISA, ALK-P, ALT, AST, CBC diff) before treatment and prior to ultrasound fill then It's given appropriate dose Ivermectin 200 microgram per kg, ie 3 mg two tablets morning and night in one day to the patient. The patients follow by phone 24 and 48 and 72 hours after treatment . They visit 15 days,1 month and 3 months after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105291155N13
Registration date: 2011-06-18, 1390/03/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-06-18, 1390/03/28
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Vince chancellor for reaserch Guilan univercity of medical sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ivermectin effect in treatment of patients with human fascioliasis
Public title
Ivermectin effect in treatment of patients with human fascioliasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: persons are over 18 years old with human fascioliasis Exclusion criteria: pregnancy;lactation;hypersensitivy to the drug
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences. Ethics Committee Gastrointestinal and Liver Diseases Research
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
955655-41488
Approval date
2011-05-26, 1390/03/05
Ethics committee reference number
ش/161

Health conditions studied

1

Description of health condition studied
Fasciola
ICD-10 code
B66.3
ICD-10 code description
Infection due to Fasciola

Primary outcomes

1

Description
Ivermectin effect in treatment of patients with Fascioliasis
Timepoint
1 month and 3 months after treatment
Method of measurement
negative ELISA- negative S/E-absence of hypereosinophilia-recovery of patients signs

Secondary outcomes

empty

Intervention groups

1

Description
Ivermectin effect in treatment of patients with Fascioliasis It's given appropriate dose Ivermectin 200 microgram per kg, ie 3 mg two tablets morning and night in one day to the patient.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and liver disease research center
Full name of responsible person
farahnaz joukar
Street address
Sardar jangle Ave-Razi hospital-Gastrointestinal and liver disease research center
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vince chancellor for reaserch Guilan univercity of medical sciences
Full name of responsible person
Dr Rasool Tabari KHomeirani
Street address
Sadati st, Samjoo st, Rasht,Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vince chancellor for reaserch Guilan univercity 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
gastrointestinal and liver disease research center (GLDRC)
Full name of responsible person
Farahnaz Joukar
Position
assistant of gastrointestinal and liver disease research center (GLDRC)
Other areas of specialty/work
Street address
gastrointestinal and liver disease research center (GLDRC) - Razi hospital - Sardar Jangal Ave.
City
Rasht
Postal code
955655-41448
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
f_jokar@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
gastrointestinal and liver disease research center (GLDRC)
Full name of responsible person
Dr.Fariboraz Mansou-Ghanaei
Position
Head / Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
gastrointestinal and liver disease research center (GLDRC) - Razi hospital - Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr. Maryam Bakhshandeh
Position
Researcher
Other areas of specialty/work
Street address
Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
bmaryamb@yahoo.com
Web page address
www.gldrc.org

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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