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Clinical trial

Use of EPs®7630 in Hand, Foot and Mouth Disease

ID
Name
EOU 2019-10
Description
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.
Trial arms
Trial start
2019-06-01
Estimated PCD
2022-06-01
Trial end
2023-01-01
Status
Completed
Phase
Early phase I
Treatment
EPs® 7630
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.
Arms:
EPs® 7630 group
Other names:
Group 1
Size
240
Primary endpoint
the patient's fever status, restlessness, inappetence, and sleeplessness scores
All patients were followed up twice more, 48 hours after the first admission and on the 5th-7th days.
Eligibility criteria
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 -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ACTUAL'}}
Updated at
2024-04-09

1 organization

1 product

3 indications

Organization
Eskisehir Osmangazi University
Product
EPs 7630
Indication
Hand
Indication
Foot
Indication
Foot and Mouth Disease