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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&#

Phase 1
Completed
Conditions
Hand-foot-and-mouth disease
Registration Number
ITMCTR2100005101
Lead Sponsor
Beijing Youan Hosptial, Captial Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
Not specified
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

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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinic outcome;mouth ulcer;Fever;herpes;
Secondary Outcome Measures
NameTimeMethod
Clinic symptoms;
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