Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins.

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Detailed Description

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Apevinat BC presents in its formula the cyproheptadine hydrochloride, which is an antihistamine and anti-serotonin with stimulant of appetite property associated with the vitamin B complex and C, in balanced amounts.

This combination is specially formulated to adequately serve patients with anorexia represented by lack of appetite or appetite diverted to diets without the necessary vitamins. For the anorexic patients that are common B and C hypovitaminosis, the use of Apevinat BC will have a synergistic and joint action to increase appetite and facilitate correction of a diet while also supplement with B and C vitamins, this association does not decreases its tolerability and safety but hits adequately the purpose of therapeutic orexigenic.

The current study will compare the efficacy and tolerability of Apevinat BC to vitamin complex administered three times a day, in the prevention and treatment of lack of appetite and B and C hypovitaminosis.

Conditions

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Lack of Appetite Anorexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin Complex

A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.

Group Type ACTIVE_COMPARATOR

Apevinat BC

Intervention Type DRUG

Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg).

Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.

Apevinat BC

Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg).

Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.

Group Type EXPERIMENTAL

Vitamin Complex

Intervention Type DRUG

A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.

Interventions

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Apevinat BC

Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg).

Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.

Intervention Type DRUG

Vitamin Complex

A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.

Intervention Type DRUG

Other Intervention Names

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MDCPharma Polivitamin, B and C Complex.

Eligibility Criteria

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Inclusion Criteria

* Patients who presents lack of appetite;
* Wash out 20 days after ingestion before similar drug;
* Responsible for the least able to understand and maintain their adherence to protocol;
* Patients of all ethnic groups of both sexes, aged 7-14 years;
* Responsible for the minor must consent to participate in the same study, through the signing of consentiment term;
* Responsible for the minor should be able to understand the proper use of medication;

Exclusion Criteria

* Patients with parasitic infections;
* Patients with angle closure glaucoma or open;
* Patients with a predisposition to urinary retention;
* Patients with peptic ulcer or stenotic pylorus-duodenal obstruction;
* debilitated patients or in acute asthma attack;
* Patients who have poor appetite caused by any serious illness;
* Patients who are taking any medications that depress the central nervous system;
* Patients who take medication monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazine, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotrophin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, Primidone, salicylates;
* Patients with known hypersensitivity to any components of the formula;
* Patients who are participating in another clinical trial;
* Inability to compliance with the protocol;
* Any condition that in the opinion of the investigator would prohibit the inclusion and patient compliance with the protocol.

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No