Efficacy and safety of Reduning Injection in patients with Hand foot and mouth disease (nervous system impairment period): a pilot randomized open study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-14005376

Enrollment

Unknown

Registered

2014-09-19

Start date

2014-04-10

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand-foot-mouth Disease

Interventions

Control group :Westen medical treatments

Test group :Westen medical treatments with RDN injection

Eligibility

Sex/Gender

All

Age

1 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Consistent with the diagnosis criteria of Foot and mouth disease treatment guidelines (China,2010), issued by China's Ministry of Health; 2. According to the Consensus on the Enterovirus 71 (EV71) infection in severe cases clinical treatment (China, 2011), Patients who are in the 2ed phase of the disease, with nervous system impairment clinical manifestations; 3. Age between 1 and 7 years; 4. Onset within 48 hours; 5. Arilla-temperatures higher than 38.5 degree, poor antipyretic effect; 6. The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Suspected of the 3rd phase or the 4th phase of severe hand-foot-mouth disease patients, that is, patients with Heart and lung failure; 2. Patients who are Suffering from severe malnutrition, rickets; 3. Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, mentally illness etc.; 4. Allergic constitution (allergic to more than 2 types of material allergy), or allgeric to the composition of the drugs in this study; 5. Have participated in clinical trials of other drugs within the past 3 months; 6. With history of Febrile seizures; 7.Other conditions that investigators believe are not suitable for the patients to be enrolled.

Design outcomes

Primary

Measure	Time frame
The time of disease going into a stable condition;	—

Secondary

Measure	Time frame
The time of body temperature going back to normal.;The proportion of patients going to normal tempera;The usage of glucocorticoid, immunoglobulin, antip;The rate of nervous system symptoms disappearance.;	—

Countries

China

Contacts

Public ContactZhu Chaomin

zhuchaomin2013@163.com+86 13648357117

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026