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Comparison between Qing Re Jie Du decoction with Kai-Hou-Jian spray and Conventional Therapy in the Treatment of Mild Hand, Foot, and Mouth Disease: A Prospective Randomized Controlled Trial and Scientific Bases

Optimization of prevention and treatment strategies for treating hand, foot and mouth with fever and rash syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049228
Enrollment
Unknown
Registered
2021-07-27
Start date
2018-01-01
Completion date
Unknown
Last updated
2022-04-04

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

Interventions

Sponsors

Beijing Youan Hosptial, Captial Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: The diagnosis of mild HFMD was established (Ministry of Health of the Peoples Republic of China, 2018) according the guidelines for the diagnosis and treatment of HFMD issued by the Ministry of Health of China in 2018. In addition, ages of children should be within the range of 1 to 5 years, the occurrence of fever or skin and oral mucosal lesions were no more than 48 hours after , and the body temperatures were between 37.5 degree C to 38.5 degree C. All patients and their guardians agreed and informed consent forms before enrollment.

Exclusion criteria

Exclusion criteria: Patients had neurogenic pulmonary edema or heart or respiratory failure, chronic hepatitis, congenital heart disease, or acute or chronic nephritis; had a history of allergy to herbal medicine, or mild increases in bilirubin, intravascular hemolysis. Patients had been taken other Chinese herbal medicines or antivirals, hormonal therapy or participated in other clinical studies on HFMD, and had any condition that could have interfered with the evaluation of the study objectives.

Design outcomes

Primary

MeasureTime frame
Clinic outcome;Fever;herpes;mouth ulcer;

Secondary

MeasureTime frame
Clinic symptoms;

Countries

China

Contacts

Public ContactXiuhui Li

Beijing Youan Hospital, Capital Medical University

lixiuhui@sohu.com+86 13501273210

Outcome results

None listed

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