A randomized, parallel controlled clinical trial of honeysuckle oral liquid in the treatment of children with Hand-foot- and- mouth Disease invading lung and splee

Phase 4

• Conditions: Hand-foot-and-mouth Disease

• Registration Number: ITMCTR2100005397
• Lead Sponsor: Enshi Tujia and Miao Autonomous Prefecture Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Over 0.5 years old, regardless of gender;

2) Comply with the diagnostic criteria for hand, foot and mouth disease specified in the guidelines for diagnosis and treatment of hand, foot and mouth disease (2018 Edition) issued by the general office of the National Health Commission; The TCM syndrome differentiation of damp heat and toxin excess syndrome in line with the clinical diagnosis and treatment guide of Pediatrics of traditional Chinese medicine. Hand, foot and mouth disease.

3) The course of disease was 24-48 hours and no other antiviral drugs were used before treatment;

4) Those who voluntarily sign the informed consent form.

Exclusion Criteria

1) Age < 0.5 years

2) Exclude diseases that need to be distinguished from hand, foot and mouth disease, such as atypical measles, rubella, infant emergency rash, chickenpox / herpes zoster and papular urticaria.

3) Headache and vomiting; Mental retardation, drowsiness, easily startled, delirium and any other manifestations of nervous system involvement;

Limb shaking, muscle clonus, nystagmus, ataxia, eye movement disorder;

Weakness or acute flaccid paralysis;

Symptoms of convulsion and meningeal irritation, weakening or disappearance of tendon reflex, frequent convulsions, coma, hernia, dyspnea, cyanosis, bloody sputum, pulmonary rales, shock and other circulatory dysfunction, etc.

4) Children with severe primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system and mental illness;

5) With pharyngeal conjunctivitis, acute obstructive laryngotracheal bronchitis, bronchiolitis, pneumonia, active tuberculosis, bronchiectasis or other basic lung diseases;

6) Those who have used other Chinese and Western drugs for the treatment of the disease within 48 hours (such as glucocorticoid, human gamma globulin, interferon, traditional Chinese medicine, etc.);

7) Those who have known a history of allergy to the components of this drug, and those who have allergies to food and more than 2 drugs;

8) Those who have participated in other clinical trials within 1 month;

9) Other reasons that doctors consider unsuitable for inclusion;

10) The family disagreed

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recovery time of hand-foot -and- mouth disease (disappearance of main symptoms);

Secondary Outcome Measures

Name	Time	Method
Measure the body temperature (axillary temperature) every 8 hours, record the first diagnosis body temperature of the subjects until the body temperature drops below 37.4 ?, and there is no time required for repetition within 24 hours;; The initial and complete regression time of rash and oral herpes;