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Study aim: To evaluate the clinical efficacy of Pelargonium sidoides root extract (EPs 7630) in the treatment of cough in acute viral bronchitis among children aged 6 months to 6 years attending the Children’s Medical Center Hospital. Design: Blinding will be performed in a double-blind manner using identical drug and placebo formulations. Participants will be randomly assigned to groups using a block randomization method, Settings and conduct: his study will be conducted as a randomized, triple-blind clinical trial (patient, investigator, and data analyst) over a period of six months on patients aged 6 months to 6 years presenting with symptoms of acute viral bronchitis to the emergency outpatient clinic of the Children’s Medical Center Hospita Participants/Inclusion and exclusion criteria: Inclusion Criteria: Children aged 6 months to 6 years without underlying conditions diagnosed with acute bronchitis. Onset of symptoms less than 48 hours before enrollment ( Symptom severity: Bronchitis Severity Score (BSS) ≤ 5 Exclusion Criteria: Use of antibiotics within the past two weeks. Use antihistamines. Use of cold medications Non-compliance with follow-up visi Intervention groups: n the symptomatic treatment of acute viral bronchitis in children aged 6 months to 6 The initial visit will be conducted at the time of enrollment, and the final follow-up visit will take place on day seven. The Bronchitis Severity Score (BSS) is used to assess disease severity based on the patient’s clinical symptoms and includes cough, pulmonary rales on auscultation, and dyspnea. The presence and severity of each symptom are evaluated using a five-point scale as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. Main outcome variables: Does Pelargonium sidoides root extract (EPs 7630) affect the duration of fever in children aged 6 months to 6 years attending the Children’s Medical Center Hospital?
IRCTID: IRCT20250926067363N1
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