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The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months. |
|
| L-carnitine | Experimental | Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months. |
|
| Biotin | Experimental | Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function test (PFT) | 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. | 3 months |
| Childhood asthma control test (C-ACT) | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum levels of TGF-β1 | the change in serum levels of TGF-β1 | at baseline and 3 months after intervention |
| serum levels of TNF-α | Change in serum level of TNF-α |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospital | Tanta | Gharbia Governorate | 6620010 | Egypt |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| D013607 | Tablets |
| D001710 | Biotin |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| L-Carnitine 500Mg Oral Tablet | Drug | Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months. |
|
| Biotin Capsules | Drug | Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months. |
|
| at baseline and 3 months after intervention |
| serum levels of 8-OHDG | the change in serum levels of 8-OHDG | at baseline and 3 months after intervention |
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |