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Effectiveness of Cyproheptadine Hydrochloride Against Appetite to Improve Children's Nutritional Status

NCT07006181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-06-10

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the benefits of Cyproheptadine hydrochloride in increasing appetite as well as its effect on weight gain in children aged 1-5 years who have difficulty eating. The main questions it aims to answer are:

* Is Cyproheptadine hydrochloride useful in increasing appetite in children?
* Is the Cyproheptadine hydrochloride dose given effective and efficient regarding the improvement of a child's appetite? Can giving Cyproheptadine hydrochloride improve nutritional status of children?
* How long can Cyproheptadine hydrochloride be given to increase appetite in children and what are the side effects?

Participants will:

* Take the Cyproheptadine hydrochloride every day, twice a day for 4 weeks (intervention group); take the placebo (control group)
* Have their ECAST score (score for measuring appetite in children), anthropometric measurement before and after intervention at the second visit (2 weeks), third visit (4 weeks and stop intervention), and fourth visit (8 weeks after stopping the intervention)

Conditions

  • Appetite Loss

Interventions

DRUG

cyproheptadine hydrochloride

Giving Cyproheptadine hydrochloride 0.25 mg/kg/day divided by 2 dose every 12 hours for 4 weeks.

OTHER

Giving placebo divided by 2 dose every 12 hours for 4 weeks.

Giving placebo divided by 2 dose every 12 hours for 4 weeks.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2025-02-28
Completion
2025-03-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07006181 on ClinicalTrials.gov