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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&#

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
ITMCTR
Registry ID
ITMCTR2100005100
Enrollment
Unknown
Registered
2021-07-27
Start date
2018-10-11
Completion date
Unknown
Last updated
2023-02-20

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

Control group:Conventional therapy
Andrographolide Sulfonate (Xiyanping injection), No.2 Qing Re Jie Du decoction in conjunction with conventional therapy:Andrographolide Sulfonat, No.2 Qing-Re Jie-Du decoction

Sponsors

Beijing Youan Hosptial, Captial Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Other Clinic symptoms;Herpes;fever;

Secondary

MeasureTime frame
Incidence of converse to critical condition;Incidence of complications;

Countries

China

Contacts

Public ContactXiuhui Li
lixiuhui@sohu.com+86 13919873128

Outcome results

None listed

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