NCT01283646已完成3 期
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
EMS3 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Apevitin BC
Experimental
Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily
干预措施: Apevitin BC (Drug)
Vitamin B Complex + Vitamin C
Active Comparator
Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily
干预措施: Vitamin B Complex + Vitamin C (Drug)
结局指标
主要结局
Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex.
时间窗: 30 days
Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.
次要结局
- Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex(30 days)
研究者
研究点 (3)
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