Authors
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Roberto Rodriguez Fernandez General Hospital -More
Category
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Primary study
Registry of Trials»Registro Público Cubano de Ensayos Clínicos
Year
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2017
INTERVENTION: Group 1 (experimental): Ozone Therapy + Covencional treatment ( antibiotics if infectious illnesses bacterial + especific meidication to control illnnesses associated to IgAD) . the ozone therapy is administred for the ractal manner, with a daily frecuency in cycle of 20 sessions, followed of three months sabbatical and next of 20 sessions with a daily frecuency. The management graduates of the following form: 1. childrens a)‐ elders of 4 years to 10 years ages: 1,2 mg ‐ 3mg b)‐ from 11 to 15 years ages: 2,2 mg to 4,2 mg . 2‐ Childrens bigger 15 years and adults: 2mg‐8mg. Group 2 ( Control ): Hebertrans +Covencional treatment ( antibiotics if infectious illnesses bacterial + especific meidication to control illnnesses associated to IgAD). the Hebertrans is utilized at the rate of 1 unit per square meter of the corporal surface, for the subcutaneous manner a week, during 12 weeks. Hebertrans, Ozonotherapy CONDITION: IgA Deficiency Immunoglobulin A Deficiency PRIMARY OUTCOME: Objective Response (Complete response, Partial response, Stable disease, Progressive disease). Measurement time: 2, 4 and 6 months. SECONDARY OUTCOME: Immunoglobulin's levels‐IgA, IgG, IgM (Normal, Enlarged, Diminished). Measurement time: at baseline, 4 and 6 months. Clinical State (Satisfactory, Acceptable, Equal). Measurement time: at baseline, 4 and 6 months. Oxidative‐damage scoreboards (Normal, Enlarged, Diminished). Measurement time: at baseline and, 6 months. Antirust‐ defense scoreboards: at baseline and, 6 months. Adverse Events‐AE (Occurrence of AE (Yes, No), Description of AE (name of the adverse event), Intensity of AE (Light, Moderated, Severe)). Measurement time: 2, 4 and 6 months. Illnesses associated (Occurrence of illnesses associated (Yes, No), Description of illness (Allergic, Autoimmune, Infectious)). Measurement time: at baseline. INCLUSION CRITERIA: 1‐ IgA deficiency complete or partial, selective IgA deficiency or with deficient specific antibody response, IgAD isolated or associated to allergic , autoimmune and neoplasic illness. 2‐ Informed Consent of the parents for the participation of childrens in the study or Signed informed consent of the adults .
Epistemonikos ID: 5e0f4b9ffe6b85aebdb8af10101a1c2533cd2238
First added on: Aug 23, 2024