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

NCT06353477 | Completed Phase 2 DMC

• 1 other identifier: EOU 2019-10
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hand, foot, and mouth disease

Outcome Measures

Primary Outcomes (1)

• the patient's fever status, restlessness, inappetence, and sleeplessness scores

  score

  All patients were followed up twice more, 48 hours after the first admission and on the 5th-7th days.

Study Arms (2)

EPs® 7630 group

ACTIVE COMPARATOR

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.

Drug: EPs® 7630

control grup

NO INTERVENTION

Control group did not receive any herbal medication.

Interventions

EPs® 7630 DRUG

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.

Also known as: Group 1

EPs® 7630 group

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed with Hand, foot, and mouth disease

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead
• Abdi Ibrahim Ilac San. ve Tic A.S.: collaborator

Study Sites (1)

Istinye University Medicine Faculty Hospital

Esenyurt, Istanbul, 34517, Turkey (Türkiye)

Location

Related Publications (2)

• Miller GD, Tindall JP. Hand-foot-and-mouth disease. JAMA. 1968 Mar 4;203(10):827-30. No abstract available.

  PMID: 5694203 BACKGROUND

• Sutcu M, Kara M, Yildiz F, Kilic O, Tural Kara T, Akkoc G, Buyukcam A, Elmas Bozdemir S, Ozgur Gundeslioglu O, Gul D, Iseri Nepesov M, Kara A. Hand, foot, and mouth disease: could EPs(R) 7630 be a treatment option? A prospective randomized open-label multicenter clinical study. Front Pediatr. 2024 May 20;12:1274010. doi: 10.3389/fped.2024.1274010. eCollection 2024.

  PMID: 38832001 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Model Details: 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 Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: June 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: March 2024- June 2024
• Access Criteria: researchers

Locations

TU (1)