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Completed

NCT Number: NCT07006181

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

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)

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Key information

Conditions

Appetite Loss Anorexia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citra Arafiq Hospital

Jakarta, Indonesia

About this study

This study was conducted in a hospital in the Jakarta region, RS Citra Arafiq. All patients who met the inclusion criteria and had informed consent will be assessed for appetite scoring (ECAST) by the research team and diet analysis as a patient baseline before conducting research. Scoring of appetite and daily calorie achievement was carried out by the team researcher. All patients underwent anthropometric measurements (body weight, height) carried out by the team.

The intervention was carried out for 4 weeks, divided into two groups randomly. During the intervention, caregivers are asked to carry out daily observations and recordings regarding food intake (food records) and weighing 2nd week, 4th week and 8th week. Every patient who meets the inclusion criteria receives education regarding correct feeding rules. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

s:

  • Experiencing decreased appetite and/or difficulty eating
  • Poor nutritional status and/or weight faltering
  • The parents agree to participate in the research by signing an informed consent.
  • Patients have National Health Insurance or other health insurance.

Exclusion criteria

s:

  • Major congenital abnormalities
  • CNS disorders (Cerebral palsy)
  • Inborn errors of metabolism (IEM)
  • GERD (Gastro esophageal reflux disease)
  • Severe acute malnutrition

Treatment and study plan

cyproheptadine hydrochloride

Drug

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

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

Other

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

Primary outcomes

  1. ECAST children's appetite scoring

    Time frame: From enrollment, then 4 weeks to the end of treatment at 8 weeks

    ECAST children's appetite questionnaire parameters have been modified into 16 questions and have been validated and implemented. This instrument is about a child's appetite ask most parents or caregivers understand the child's condition at all times. The results of this questionnaire will compared with the average daily calorie achievement. Responses to this instrument were coded as: 1 for "never", 2 for "sometimes" and 3 for "often". The total ECAST score is obtained by summing the responses and a higher score indicates a greater appetite.

Secondary outcomes

  1. Anthropometric status

    Time frame: From enrollment, then 4 weeks to the end of treatment at 8 weeks

    The patient's nutritional status is based on the patient's body weight ratio in kilograms to height in centimeters at when collecting research data, according to the standard deviation value WHO 2006 growth curve in weight for length type according to gender. Weighing weight and height using digital scales and infantometer/stadiometer.

  2. Calorie intake

    Time frame: From enrollment, then 4 weeks to the end of treatment at 8 weeks

    The average number of calories achieved by the children was compared with the child's calorie needs per day.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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