Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite

Study Overview
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Brief Summary
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Lack of appetite is one of the most common reasons for visits to pediatric clinics.The symptoms usually manifest after weaning when they are introduced into the diet of infant foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B and also vitamins complex.

Detailed Description
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Study Design: Multicenter Phase III Randomized Double Blind Prospective and Comparative Experiment duration: 30 days 3 visits (day 0, day 15 and day 30) Increased appetite Adverse event

Official Title
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Multicenter Clinical Study, Phase III, Randomized, Double-blind, of Prospectively Evaluate the Effectiveness and Tolerability of Apevitin BC Comparing to Vitamin Complex in Appetite Stimulation

Conditions
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Lack or Loss Appetite Nonorganic Origin

Intervention / Treatment
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* Drug: Apevitin BC
* Drug: Vitamin B Complex + Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with inappetence; Wash out 20 days after ingestion before similar drug; The charge of the patient must understand and consent in writing; Responsible for the minor must be able to understand the study procedures, agree to participate and give written consent. Exclusion Criteria: Patients with intestinal parasitoses infection; Patients with glaucoma open or closure angle; Patients with predisposition to urinary retention; Patients with stenosis peptic ulcer or pylorus - duodenal obstruction; Debilitated patients or in acute attack of asthma; Patients who have lass of appetite caused by any serious disease; Patients who make use of any drugs central nervous system depressants; Patients who make use of medicines monoamineoxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, Phenobarbital, chloramphenicol, cyclosphosphamide, cyclosporine, chlorambucil,corticotropin, mercaptopurine, isoniazid , penicillin, estrogens, contraceptives, haloperidol, ipratropium, barbiturates, primidone, salicylates. Hypersensitivity to components of the formula Patients who is participating in another clinical study; No able to adhere to protocol; Any pathology or past medical condition that can interfere with this protocol. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apevitin BC<br>Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily | Drug: Apevitin BC<br>* 3.5 to 5 ml 3 times a daily<br>|
| Active Comparator: Vitamin B Complex + Vitamin C<br>Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily | Drug: Vitamin B Complex + Vitamin C<br>* 3.5 to 5 ml 3 times a daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex. | Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex | The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability. | 30 days |