The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pulmonary function test (PFT)
研究概览
简要总结
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with moderate persistent asthma
- •Age range of 8-< 18 years old
排除标准
- •Children with any pulmonary or chronic systemic diseases other than asthma (cystic fibrosis, bronchiectasis, tuberculosis, diabetes mellitus, and liver disease).
- •Children with immunodeficiency.
- •Children with thyroid disorder.
- •Children with recent infection (especially pneumonia), surgery, anesthesia.
- •Children having clinical evidence of any heart renal and hepatic diseases.
- •Children having cystic fibrosis or congenital respiratory disease.
- •Children having chronic diarrhea and mal-absorption.
- •Children having clinical evidence of malnutrition.
- •Children on medications that could interfere with L-carnitine level including antibiotics use. (particularly ampicillins) and anti- convulsing particularly valoproic acid.
研究组 & 干预措施
Placebo
Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
干预措施: Placebo (Drug)
L-carnitine
Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.
干预措施: L-Carnitine 500Mg Oral Tablet (Drug)
Biotin
Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.
干预措施: Biotin Capsules (Drug)
结局指标
主要结局
Pulmonary function test (PFT)
时间窗: 3 months
Pulmonary Function Test (PFT) using a calibrated computerized spirometer. Subjects will be submitted to 3 acceptable Forced Vital Capacity (FVC) maneuvers according to American Thoracic Society recommendations (NIH, 2007). The maximum percentage in Forced Expiratory Volume in 1 second (FEV1) value from 3 readings will be calculated.
Childhood asthma control test (C-ACT)
时间窗: 3 months
Childhood-Asthma Control Test (C-ACT) is a 7-item child- and caregiver-completed tool with a scoring range of 0-27. The higher scores indicate better control. A score of 19 or less indicates that the asthma is not well controlled.
次要结局
- serum levels of 8-OHDG(at baseline and 3 months after intervention)
- serum levels of TGF-β1(at baseline and 3 months after intervention)
- serum levels of TNF-α(at baseline and 3 months after intervention)
研究者
Mohamed osama khedr
Clinical pharmacist
Tanta University