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
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?
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
“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).”
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
Age
From 6 months old to 6 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Single
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences children medical cener
Street address
“No. 62, Dr. Gharib Street, Children’s Medical Center
City
tehran
Province
Tehran
Postal code
1419733151
Approval date
2025-08-01, 1404/05/10
Ethics committee reference number
IR.TUMS.CHMC.REC.1404.145
Health conditions studied
1
Description of health condition studied
Acute bronchitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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
Category
Treatment - Other
2
Description
the second group will also receive placebo treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
children medical center
Full name of responsible person
Rohola Shirzadi
Street address
No. 62, Dr. Gharib Street, Children’s Medical Center.
City
Teheran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9999
Email
shirzadi123@yahoo.com
Web page address
https://chmc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rohola Shirzadi - ramin kordi
Street address
No. 62, Dr. Gharib Street, Children’s Medical Center.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9999
Email
shirzadi123@yahoo.com
Web page address
https://chmc.tums.ac.ir
Grant name
“From the research budget of the faculty/research center
Grant code / Reference number
۱۴۰۴-۱-۳۶۵-۷۵۱۹۱
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rohola shirzadi
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 62, Dr. Gharib Street, Children’s Medical Center
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9999
Email
shirzadi123@yahoo.com
Web page address
https://chmc.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rohola shirzadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 62, Dr. Gharib Street, Children’s Medical Center
City
tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
shirzadi123@yahoo.com
Web page address
https://chmc.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rohola shirzadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9999
Email
shirzadi123@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after de-identification of individuals.”
When the data will become available and for how long
From publication until 6 months thereafter.”
To whom data/document is available
he data will be available only to researchers affiliated with academic or scientific
Under which criteria data/document could be used
faculty members of the university.
From where data/document is obtainable
“They should contact via the email address: shirzadi123@yahoo.com
What processes are involved for a request to access data/document
“It will be sent within one week after identity verification