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OpenTrials
Completed

NCT Number: NCT01283646

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

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.

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Apevitin BC

Drug

3.5 to 5 ml 3 times a daily

Vitamin B Complex + Vitamin C

Drug

3.5 to 5 ml 3 times a daily

Primary outcomes

  1. Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex.

    Time frame: 30 days

    Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.

Secondary outcomes

  1. Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex

    Time frame: 30 days

    The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Acronym: Inappetence

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2011
Registry last updated
Feb 24, 2021

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.