- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06353477
Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option
Use of EPs®7630 in Hand, Foot and Mouth Disease
Study Overview
Detailed Description
Study design This multicenter randomized controlled study was conducted between June 2019- June 2022 in 8 centers in Turkey. These centers were hospitals of reference that provided tertiary care services. The clinical study protocol was approved by the Eskisehir Osmangazi University. This clinical study protocol was approved by the Eskisehir Osmangazi University Interventional Research Ethics Committee with the number 2019-10 and conducted in accordance with the World Medical Association's Declaration of Helsinki and on Good Clinical Practice compliance. This study was conducted with the approval of the Turkish Medicines and Medical Devices Agency Written informed consent was obtained from parents of all patients included in the study.
Study participants and clinical management All of pediatric patients who were examined by a pediatrician and diagnosed with HFMD and start of the symptoms in last 48 hours (either fever or enanthems or exanthem) were offered trial participation. Patients whose complaints lasted more than 48 hours, those whose families stated that they were unable to comply with follow-ups, those did not give informed consent, those taking another antiviral or supportive treatment, those who had used antibiotics in the previous 1 month, those with a history of immunodeficiency or a family history of immunodeficiency, and those with a previous history of anaphylaxis with any supplement or drug, any chronic disease, or skin lesion were not included in the study.
At the first admission, the duration of the patients' complaints, the distribution of the lesions in the body, and the fever status were recorded. Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10.
Participants were assigned 1:1 to one of two trial arms by a local research team member using a centralized computerized randomization system (RAND2 software, The MathWorks Inc, Natick, United States, contractually managed by the data management team). Lists in four blocks were added to the automatic online randomization system to ensure a homogeneous distribution of the groups in both study centers. On the basis of the power calculations of similar studies, a minimum sample size of 80 per group was calculated to give a 90% probability (power) of producing a significant finding. Overall, 120 patients were designated for the for each group that considering that there may be losses in the study.
All patients were followed up twice more, 48 hours after the first admission and on the 5th-7th days. Another phone evaluation was conducted for those with continued complaints from the previous visit. During these visits, the patient's fever status, restlessness, inappetence, and sleeplessness scores were asked again of their parents and recorded. Patient medication adherence and drug side effects were evaluated. After the patient's recovery, the total duration of the disease and the duration of restlessness, inappetence, and sleeplessness were recorded. Patients who were hospitalized or developed complications were noted.
Intervention EPs® 7630 is an extract from the roots of Pelargonium sidoides, drug-extract ratio 1 : 8-10, extraction solvent ethanol 11% (w/w). The patients were divided into two groups: (i) group 1 received herbal drug EPs® 7630 by oral route [Umca® solution; (3x10 drops; between 1-5 years of age, 3x20 drops; 6-12 years of age, 3x30 drops for children >12 years of age)] for 7 days and (ii) group 2 (control group) did not receive any herbal medication. The medication was administered orally, at least 30 minutes before or after meals. Patients in both groups were prescribed paracetamol (10 mg/kg/dose, 4 times a day, maximum 4,000 mg/day.) as an antipyretic agent. Temperature measurement was made at home and in the hospital via the axillary route.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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İstanbul
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Esenyurt, İstanbul, Turkey, 34517
- Istinye University Medicine Faculty Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Patients diagnosed with Hand, foot, and mouth disease
Exclusion Criteria:
- Patients whose complaints lasted more than 48 hours
- Unable to comply with follow-ups,
- Did not give informed consent,
- Another antiviral or supportive treatment,
- Use antibiotics in the previous 1 month,
- A history of immunodeficiency or a family history of immunodeficiency,
- A previous history of anaphylaxis with any supplement or drug,
- Any chronic disease, or skin lesion -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: EPs® 7630 group
The patients were divided into two groups: (i) group 1 received herbal drug EPs® 7630 by oral route [Umca® solution; (3x10 drops; between 1-5 years of age, 3x20 drops; 6-12 years of age, 3x30 drops for children >12 years of age)] for 7 days.
|
EPs® 7630 is an extract from the roots of Pelargonium sidoides, drug-extract ratio 1 : 8-10, extraction solvent ethanol 11% (w/w).
The patients were divided into two groups: (i) group 1 received herbal drug EPs® 7630 by oral route [Umca® solution; (3x10 drops; between 1-5 years of age, 3x20 drops; 6-12 years of age, 3x30 drops for children >12 years of age)] for 7 days and (ii) group 2 (control group) did not receive any herbal medication.
The medication was administered orally, at least 30 minutes before or after meals.
Patients in both groups were prescribed paracetamol (10 mg/kg/dose, 4 times a day, maximum 4,000 mg/day.)
as an antipyretic agent.
Temperature measurement was made at home and in the hospital via the axillary route.
Other Names:
|
No Intervention: control grup
Control group did not receive any herbal medication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the patient's fever status, restlessness, inappetence, and sleeplessness scores
Time Frame: All patients were followed up twice more, 48 hours after the first admission and on the 5th-7th days.
|
score
|
All patients were followed up twice more, 48 hours after the first admission and on the 5th-7th days.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EOU 2019-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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