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Comparison between Andrographolide Sulfonate, No.2 Qing Re Jie Du decoction and Conventional Therapy in the Treatment of Severe Hand, Foot, and Mouth Disease: A Prospective Randomized Controlled&#

Phase 1
Completed
Conditions
Hand-foot-and-mouth disease
Registration Number
ITMCTR2100005100
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

According the guidelines for the diagnosis and treatment of HFMD issued by the Ministry of Health of China in 2018, the diagnosis of severe HFMD was established. children aged 1-5 years; no more than 24 hours after the occurrence of central nervous system symptoms, such as lethargy and weakness, agitation or irritability, headache, vomiting, limb weakness or acute flaccid paralysis, myoclonic jerks, ataxia, nystagmus, and oculomotor palsies.

Exclusion Criteria

The excluded criteria were considered as: 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. In addition, patients had been taken 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
Other Clinic symptoms;Herpes;fever;
Secondary Outcome Measures
NameTimeMethod
Incidence of converse to critical condition;Incidence of complications;
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