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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01283646

Acronym

Inappetence

Enrollment

Registered

2011-01-26

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lack or Loss Appetite Nonorganic Origin

Brief summary

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

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

Interventions

DRUGApevitin BC

3.5 to 5 ml 3 times a daily

DRUGVitamin B Complex + Vitamin C

3.5 to 5 ml 3 times a daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026