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

EMS

Status and phase

Completed

Phase 3

Conditions

Lack or Loss Appetite Nonorganic Origin

Treatments

Drug: Apevitin BC

Drug: Vitamin B Complex + Vitamin C

Study type

Interventional

Funder types

Industry

Identifiers

NCT01283646

TRPEMS0910

Details and patient eligibility

About

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.

Full 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

Enrollment

51 patients

Sex

All

Ages

5 to 15 years old

Volunteers

Accepts Healthy Volunteers

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.