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Comparing the effect of low dose and standard dose Cyproheptadine on BMI enhancement in children aged 2-10 and evaluation of its side effects

Comparing the effect of low dose and standard dose Cyproheptadine on BMI enhancement in children aged 2-10 and evaluation of its side effects

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240213060992N1
Enrollment
90
Registered
2024-07-20
Start date
2024-07-26
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

thinness.

Interventions

Intervention 1: Intervention group1: low dose cyproheptadine , children aged 2 to 5 years will receive 2.5 ml of oral solution of 2 mg/5 ml terzamine solution of Amin pharmaceutical company every nigh

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

Inclusion criteria: Consent of the child's guardian to participate in the study Being aware and vigilant of the guardian of the child Age 2 to 9 years and 6 months at the first visit BMI Z-score is less than -2 standard deviations in the BMI table according to age and sex of the CDC, which is set based on 15day intervals.

Exclusion criteria

Exclusion criteria: Celiac disease, Crohn's disease, sensitivity to cow's protein, hypothyroidism, hyperthyroidism, congenital megacolon, eosinophilic gastroenteritis, cystic fibrosis and any disease that causes malabsorption. Allergy to antihistamines Consumption of other appetite stimulants and multivitamins and zinc in the study Treatment with growth hormone, gonadotropin-releasing hormone analog, aromatase inhibitors, recombinant human-like growth factor and androgen in the study Entering stage 1 of puberty including the enlargement of testicles in boys, growth of pubic hair in boys, breast enlargement in girls

Design outcomes

Primary

MeasureTime frame
Determination and comparison of average BMI changes in the groups under investigation in repeated measurements during the study period. Timepoint: The start of the study, one month, two months, three months and four months after the start of the study. Method of measurement: Scale and meter, the measurement accuracy for weight will be 0.1 kg and for height 0.1 cm. To measure height and weight, the child will be without shoes.;Determining the percentage of side effects caused by cyproheptadine consumption (drowsiness, irritability, headache, nausea, diarrhea, restlessness, moodiness, muscle weakness, constipation, insomnia, skin rash) in repeated measurements during the study period. Timepoint: The start of the study, one month, two months, three months and four months after the start of the study. Method of measurement: The researcher-made checklist includes drug complications based on the NIH criteria, asking parents and recording the presence or absence of complications.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegar Javidmehr

Shahre-kord University of Medical Sciences

negarjavidmehr@gmail.com+98 31 3364 7459

Outcome results

None listed

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