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Which one is more effective in cyclic vomiting syndrome treatment? Cyproheptadine or Amitriptyline ?

Comparison the effect of Cyproheptadine and Amitriptyline Prophylactic therapy on cyclic vomiting syndrome in Pediatrics

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014030416844N1
Enrollment
60
Registered
2015-10-20
Start date
2015-10-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cyclical vomiting syndrome. Nausea and vomiting

Interventions

Intervention 1: 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. Intervention 2: Control group: In th
Treatment - Drugs
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.
Control group: In the other group we will start Cyptoheptadine for patients with the dosage of 0.1-0.2 mg/kg BID.

Sponsors

Vice Chancellor of Research of Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 15 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShervin Badihian

Isfahan University of Medical Sciences, School of Medicine, Students' Research Center

badihian@edc.mui.ac.ir+98 31 3627 7831

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026