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Huashi Baidu Granule in the Treatment of Pediatric Patients With Mild Coronavirus Disease 2019

NCT05501288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-08-16

No results posted yet for this study

Summary

The investigators conducted a single-center, open-label, parallel-group randomized controlled trial to assess the efficacy and safety of a Chinese herb compound granule Huashi Baidu granule (HSBDG) in pediatric patients with laboratory-confirmed mild COVID-19. 108 recruited children (aged 3 to 18 years) with laboratory-confirmed mild COVID-19 were randomly allocated 2:1 to receive oral HSBDG for 5 consecutive days (intervention group) and to receive compound pholcodine oral solution for 5 consecutive days (control group). The negative conversion time of SARS-CoV-2 nucleic acid and symptom scores were recorded.

Conditions

  • Coronavirus Disease 2019

Interventions

DRUG

Huashi Baidu granule

Patients were given HSBDG the day after randomization, with a dose of 2.5g for age 3 to 6 years, 5 g for age 7 to 12 years, and 10 g for age 13 to 18 years, twice daily for 5 consecutive days.

DRUG

compound pholcodine oral solution

Patients were given compound pholcodine oral solution (Bright Future Pharmaceuticals Factory, Hong Kong, CHN) the day after randomization, with a dose of 5 ml for age 3 to 6 years and 10 ml for age 7 to 18 years, three times daily for 5 consecutive days.

Sponsors & Collaborators

  • Shanghai Children's Medical Center

    lead OTHER

Principal Investigators

  • Jian Gao, MD · Shanghai Children's Medical Center

  • Yong Yin, MD · Shanghai Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05501288 on ClinicalTrials.gov