Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06353477 |
| Other study ID # |
EOU 2019-10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Eskisehir Osmangazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This randomized controlled study aims to evaluate the effectiveness and safety of the
pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in
children. The study will investigate the impact of EPs® 7630 on the severity of the disease
over a specific period and its effects on hospitalization rates and potential complications.
This research aims to contribute to the treatment of hand, foot, and mouth disease in
children.
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.
