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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:
Participants will:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyproheptadine hydrochloride | Experimental | Giving Cyproheptadine hydrochloride dossage 0.25 mg/kg/day divided by 2 dose every 12 hours for 4 weeks. |
|
| Control group | Placebo Comparator | Giving placebo and divided by 2 dose every 12 hours for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyproheptadine hydrochloride | Drug | Giving Cyproheptadine hydrochloride 0.25 mg/kg/day divided by 2 dose every 12 hours for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment, then 4 weeks to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment, then 4 weeks to the end of treatment at 8 weeks |
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Inclusion criterias:
Exclusion criterias:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citra Arafiq Hospital | Jakarta | Indonesia |
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| ID | Term |
|---|---|
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| 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. |
|
| Calorie intake | The average number of calories achieved by the children was compared with the child's calorie needs per day. | From enrollment, then 4 weeks to the end of treatment at 8 weeks |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |