Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite (Inappetence)
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ClinicalTrials.gov Identifier: NCT01283646 |
Recruitment Status :
Completed
First Posted : January 26, 2011
Last Update Posted : February 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lack or Loss Appetite Nonorganic Origin | Drug: Apevitin BC Drug: Vitamin B Complex + Vitamin C | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Apevitin BC
Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily
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Drug: Apevitin BC
3.5 to 5 ml 3 times a daily |
Active Comparator: Vitamin B Complex + Vitamin C
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
3.5 to 5 ml 3 times a daily |
- 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.
- 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.

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Ages Eligible for Study: | 5 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283646
Brazil | |
Faculdade de Medicina do ABC | |
Santo André, SP, Brazil | |
Clínica A/Z | |
São Paulo, SP, Brazil | |
Clínica Dr. Felício Savioli | |
São Paulo, SP, Brazil |
Study Director: | Felipe Pinho, MD | EMS |
Responsible Party: | EMS |
ClinicalTrials.gov Identifier: | NCT01283646 |
Other Study ID Numbers: |
TRPEMS0910 |
First Posted: | January 26, 2011 Key Record Dates |
Last Update Posted: | February 24, 2021 |
Last Verified: | March 2013 |
Vitamins Ascorbic Acid Folic Acid Vitamin B Complex Micronutrients |
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