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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250926067363N1

Enrollment

Registered

2026-04-30

Start date

2026-02-20

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute bronchitis.

Interventions

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 month

Eligibility

Sex/Gender

All

Age

6 Months to 6 Years

Inclusion criteria

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).”

Exclusion criteria

Exclusion criteria: “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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRohola shirzadi

Tehran University of Medical Sciences

shirzadi123@yahoo.com+98 21 6147 9999

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026