Appetite LossNCT07006181
Effectiveness of Cyproheptadine Hydrochloride Against Appetite to Improve Children's Nutritional Status
A study testing cyproheptadine hydrochloride in people with Appetite Loss, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Appetite Loss
- What is being tested?
- cyproheptadine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Nov 2024to 31 Mar 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Major congenital abnormalities
- CNS disorders (Cerebral palsy)
- Inborn errors of metabolism (IEM)
- GERD (Gastro esophageal reflux disease)
- Severe acute malnutrition
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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)
Read the detailed description
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).
- Conditions
- Appetite Loss
- Being tested
- cyproheptadine hydrochloride, Giving placebo divided by 2 dose every 12 hours for 4 weeks.
- Keywords
- Cyproheptadine hydrochloride, appetite loss, children, mild malnutrition
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyproheptadine hydrochlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cyproheptadine hydrochloride | Experimental | Giving Cyproheptadine hydrochloride dossage 0.25 mg/kg/day divided by 2 dose every 12 hours for 4 weeks. Receives: Drug: cyproheptadine hydrochloride |
| Control group | Placebo comparator | Giving placebo and divided by 2 dose every 12 hours for 4 weeks. Receives: Other: Giving placebo divided by 2 dose every 12 hours for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECAST children's appetite scoring
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.
Measured: From enrollment, then 4 weeks to the end of treatment at 8 weeks
Secondary outcomes (2)
Anthropometric status
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.
Measured: From enrollment, then 4 weeks to the end of treatment at 8 weeks
Calorie intake
The average number of calories achieved by the children was compared with the child's calorie needs per day.
Measured: From enrollment, then 4 weeks to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start4 Nov 2024
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aryono Hendarto, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006181
- Sponsor's protocol ID
- 24081215
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No