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A Stratified,Randomized, Double-blind, Placebo controlled, Multi-center Clinical Study of the Safety and Efficacy of Jinlian Qingre Effervescent Tablets in Pediatric Patients With hand-foot and mouth disease (Evil Committed Feipi Card syndrome of TCM)

A Stratified,Randomized, Double-blind, Placebo controlled, Multi-center Clinical Study of the Safety and Efficacy of Jinlian Qingre Effervescent Tablets in Pediatric Patients With hand-foot and mouth disease (Evil Committed Feipi Card syndrome of TCM)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002355
Enrollment
Unknown
Registered
2012-07-17
Start date
2012-02-20
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

hand-foot and mouth disease (HFMD)

Interventions

Treatment:Jinlian Qingre Effervescent Tablets
Control:Placebo

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Subject who has a clinical diagnosis of Hand, Foot and Mouth Disease (HFMD); 2. Subject who has a Evil Committed Feipi Card syndrome differentiation of TCM; 3. Subjects' highest axillary temperature was between 37.3 and 38.6 degree C within 24 hours before onset 4. the course of disease <=24 hours; 5. subjects 3 years ~6 years of age (< 7 years); 6. interventions(such as antibiotics, antiviral class)or other treatments have not been used after the onset 7. The subjects' legal guardian must be aware of this trail,and voluntarily participate in the study and signed Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. A suspected hand, foot and mouth disease in patients with severe (with a nervous system involvement, convulsions, coma, or herniation, severe and critical performance) and chicken pox, herpes angina, atypical measles, children acute rash of herpes zoster, and rubella, papulesurticaria patients; subjects who have stomach Deficiency, or easy to diarrhea; 2. hyperglycemia; 3. ALT and AST >= 1.5 times ULN; 4. subjects with severe malnutrition, severe primary disease of rickets patients and combined heart, brain, lung, liver, kidney and hematopoietic and other systems, and the mentally ill; 5. Allergic constitution (more than two classes of material allergy), or composition of the test drug allergy 6. Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives 7. Participate in other clinical trials in the latest week.

Design outcomes

Primary

MeasureTime frame
time of body temperature going back to normal;

Secondary

MeasureTime frame
time of the herpes /rashes(including canker sore);time of the herpes /rashes(including canker sore);curative effect of TCM syndrome;deterioration ratio;throat swab Virus-negative transfer ratio;

Countries

China

Contacts

Public ContactSiyuan Hu

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

husiyuan1963@sina.com+86 13752009293

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026