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Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option

NCT06353477 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

  • Hand, Foot, and Mouth Disease

Interventions

DRUG

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.

Sponsors & Collaborators

  • Abdi Ibrahim Ilac San. ve Tic A.S.

    collaborator INDUSTRY

  • Eskisehir Osmangazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2022-06-01
Completion
2023-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353477 on ClinicalTrials.gov