Evaluation of Clinical Efficacy and Safety of Pelargonium Sidoides EPs 7630 Root Extract in Symptomatic Treatment of Acute viral Bronchitis in Children 6 Months to 6 Years

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2026
INTERVENTION: Intervention 1: Intervention Group: Implementation Method“This study will be conducted as a randomized, triple‐blind clinical trial (patient, investigator, and data analyst) over a period of si Xmonths on outpatients aged 6 months to 6 years presenting with symptoms of acute bronchitis to the Emergency Clinic of the Children’s Medical Center Hospital. Participants will be randomly assigned to two groups and will receive either Pelargonium sidoides root extract (EPs 7630) or placebo.For the intervention group:Infants aged 6 months to 1 year will receive Pelarzhin Kids drops (containing 136.5 mg standardized Pelargonium extract) at a dose of 20 drops (1 mL), three times daily.Children aged 1 to 6 years will receive 2.5 mL of Pelarzhin Kids syrup (containing Pelargonium sidoides root extract and honey) three times daily (morning, noon, and evening).Both formulations are manufactured by Pars Gita Darou Pharmaceutical Company. Intervention 2: the second group will also receive placebo treatment. CONDITION: Acute bronchitis. PRIMARY OUTCOME: Evaluation of Clinical Efficacy and Safety of Pelargonium Sidoides EPs ???? Root Extract in Symptomatic Treatment of Acute viral Bronchitis in Children ? Months to ? Years. Timepoint: “Day 1 and Day7. Method of measurement: “The Bronchitis Severity Score (BSS) is assessed based on the patient’s clinical symptoms, including cough, pulmonary rales on auscultation, and dyspnea. Each symptom is evaluated using a 5‐point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. The individual scores are then summed to produce a total score ranging from 0 to 1. SECONDARY OUTCOME: The change in the total BSS score between baseline (Day 1) and Day 7 has been defined as the primary outcome. To assess the safety of EPs 7630 treatment in children aged 6. Timepoint: “Day 1 and Day 7. Method of measurement: pulmonary rales on auscultation, and dyspnea. Each symptom is evaluated using a 5‐point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. The scores are then summed to generate a total score ranging from 0 to 12. INCLUSION CRITERIA: “Symptoms with a Bronchitis Severity Score (BSS) = 5”“(BSS) = ?” n children aged 6 months to 6 years without underlying conditions who develop bronchitis, the severity is typically mild to moderat Acute onset of symptoms less than 48 hours before enrollment (first visit).”
Epistemonikos ID: a336b306d2d7440878d4b579dbacf1eb6e0d7ea2
First added on: Aug 08, 2026