Our goal is to evaluate the efficacy of cyproheptadine and amitriptyline administration in patients with cyclic vomiting syndrome (CVS) and compare the results with each other. It is worthy to note that other drugs are also suggested before as the treatment for CVS, however amytriptiline and cyproheptadine are among the drugs with more supporting evidence on this subject. For this purpose, we will enroll 60 patents with CVS in the study and divide them into two groups of cyproheptadine and amytriptiline. Patients need to be children 3-15 years old, with diagnosis of cyclic vomiting syndrome based on Rome III criteria. Normal neurological and developmental examination are needed and patients with known metabolic disease and obstructive disease of gastrointestinal or urinary system will be excluded from the study. The study is designed single-blinded and patients don't know about their medication. This is a 2-3 phase trial and is run in one center only. Patients will be followed for six months and will be observed closely for their episodes of the disease. At the end, we will compare the severity of cyclic vomiting syndrome symptoms as the primary outcome, between groups, to find the more effective treatment. Results of this study may help physicians to prescribe the appropriate drug for their patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030416844N1
Registration date:2015-10-20, 1394/07/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-20, 1394/07/28
Registrant information
Name
Shervin Badihian
Name of organization / entity
Isfahan University of Medical Sicences
Country
Iran (Islamic Republic of)
Phone
+98 31 1627 9766
Email address
badihian@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research of Isfahan University of Medical Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Cyproheptadine and Amitriptyline Prophylactic therapy on cyclic vomiting syndrome in Pediatrics
Public title
Which one is more effective in cyclic vomiting syndrome treatment? Cyproheptadine or Amitriptyline ?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children 3-15 years old with diagnosis of cyclic vomiting syndrome (based on Rome III criteria: 1 Stereotypical episodes of vomiting regarding onset (acute) and duration (less than 1 week); 2) Three or more discrete episodes in the prior year; and 3) Absence of nausea and vomiting between episodes and absence of metabolic, gastrointestinal, central nervous system structural or biochemical disorders); Normal Neurological and Developmental examination
Exclusion criteria: Known metabolic disease; Obstructive disease of gastrointestinal or urinary system; Patients who don't give consent to participate in the study or want to leave the study anytime.
Age
From 3 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Postal code
8174673461
Approval date
2014-04-21, 1393/02/01
Ethics committee reference number
292210
Health conditions studied
1
Description of health condition studied
Cyclical vomiting syndrome
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Severity of cyclic vomiting syndrome
Timepoint
From the recruitment date to 6 months after starting the medication. Patients are followed every two weeks after starting the medication.
Method of measurement
questionnaire (evaluating number of attacks, duration of attacks, number of hospitalization)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In one group we will start Amitriptyline for patients with the dosage of 1 mg/kg daily. Patients won't be aware of their drugs.
Category
Treatment - Drugs
2
Description
Control group: In the other group we will start Cyptoheptadine for patients with the dosage of 0.1-0.2 mg/kg BID.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Mousa Sadr Clinic
Full name of responsible person
Shervin Badihian
Street address
Foroughi St.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Nematbakhsh
Street address
Hezar Jarib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research of Isfahan 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
Isfahan University of Medical Sciences, School of Medicine, Students' Research Center
Full name of responsible person
Shervin Badihian
Position
Medical Student
Other areas of specialty/work
Street address
Hezar Jarib St.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3627 7831
Fax
Email
badihian@edc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, child Growth and Development Research Center
Full name of responsible person
Omid Yaghini
Position
Member of Faculty of Medicine/ MD, Pediatrician
Other areas of specialty/work
Street address
Hezar Jarib St.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
Email
yaghini.med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences, School of Medicine, Students' Research Center
Full name of responsible person
Shervin Badihian
Position
Medical Student
Other areas of specialty/work
Street address
Hezar Jarib St.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3627 7831
Fax
Email
badihian@edc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)