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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin Complex | Active Comparator | 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. |
|
| Apevinat BC | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apevinat BC | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of Apevinat BC in appetite stimulation. | Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the tolerability of Apevinat BC in appetite stimulation. | To evaluate the tolerability of Apevinat BC in appetite stimulation compared to vitamins. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anete S Grumach, Investigator | Contact | 55 (11) 4993-5468 | grumach@usp.br | |
| Adriana P Albuquerque, Coordenator | Contact | 55 (11) 4438-3558 | adrianaalbuquerque@fmabc.br |
| Name | Affiliation | Role |
|---|---|---|
| Joaquim CS D' Azevedo, Investigator | A/Z Clinical | Principal Investigator |
| Felicio S Neto, Investigator | Dr. Felicio Savioli Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ABC School of Medicine | São Paulo | São Paulo | 09060-650 | Brazil |
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| ID | Term |
|---|---|
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| Vitamin Complex | 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. |
|
|
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |