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IRCT20250926067363N1 IRCT 2026-04-30 Tehran University of Medical Sciences 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 Bronchitis Severity Scale (BSS), clinical outcome, acute bronchitis, Pelargonium Sidoides EPs ۷۶۳۰ Root extract 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 2026-02-20 anticipated 60 Complete https://irct.ir/trial/87728 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Other design features: defined as the primary outcome. To evaluate the safety of EPs 7630 treatment in children aged 6 months to 1 year, adverse events will be assessed at each visit.Integrative Medicine Outcome Scale (IMOS): A 5-point Likert verbal scale used to assess the patient’s overall health status.Integrative Medicine Patient Satisfaction Scale (IMPSS): A 5-point Likert verbal scale used to assess the level of satisfaction with the treatmen, Randomization description: the intervention and control groups, using SPSS software. The random sequence will be generated using the RV.UNIFORM function in SPSS, and participants will be selected systematically at intervals of 5 from the main list. The randomization sequence will be kept in sealed envelopes and will only be revealed after data analysis to determine group allocation. In this study, children will be evaluated by a pediatric specialist at two time points: an initial visit upon enrollment and a follow-up visit on day 7, Blinding description: identical. A double-blind approach is used, with the drugs labeled as A and B. The actual identity of each code (drug or placebo) will only be revealed after data analysis. 4 Acute bronchitis. 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 six months 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. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identification of individuals.” When: From publication until 6 months thereafter.” To whom: he data will be available only to researchers affiliated with academic or scientific Conditions: faculty members of the university. Where to obtain: “They should contact via the email address: shirzadi123@yahoo.com How to obtain: “It will be sent within one week after identity verification Comments:
public Rohola shirzadi
No. 62, Dr. Gharib Street, Children’s Medical Center
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6147 9999 shirzadi123@yahoo.com Tehran University of Medical Sciences scientific Rohola shirzadi
No. 62, Dr. Gharib Street, Children’s Medical Center
tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 0024 shirzadi123@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) “Symptoms with a Bronchitis Severity Score (BSS) ≤ 5”“(BSS) ≥ ۵” 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).” 6 months 6 years Both “Use of antibiotics within the past two week “Use of other medications such as antihistamines Irregular use of medication Lack of compliance with follow-up visits old medications or other oral drugs that may interfere with the improvement of the patient’s symptom Treatment - Other Placebo 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 six months 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 the second group will also receive placebo treatment. Evaluation of Clinical Efficacy and Safety of Pelargonium Sidoides EPs ۷۶۳۰ Root Extract in Symptomatic Treatment of Acute viral Bronchitis in Children ۶ Months to ۶ 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. 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. Tehran University of Medical Sciences Approved 2025-08-01 Ethics committee of tehran University of Medical Sciences children medical cener “No. 62, Dr. Gharib Street, Children’s Medical Center tehran Tehran Iran (Islamic Republic of)