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

NCT05501288 | Completed

• 1 other identifier: SCMCIRB-K2022046-1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19; SARS-CoV-2; Omicron; Traditional Chinese Medicine; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Time for SARS-CoV-2 nucleic acid negative conversion

  The primary outcome of the study was the time for SARS-CoV-2 nucleic acid negative conversion after randomization. The time from day 0 to the day of two consecutive negative reports confirmed was defined as the negative conversion time.

  up to three weeks

Secondary Outcomes (1)

• Symptom score, antibiotic use, and side effects

  up to three weeks

Study Arms (2)

intervention group

EXPERIMENTAL

receive oral HSBDG for 5 consecutive days

Drug: Huashi Baidu granule

control group

OTHER

receive compound pholcodine oral solution for 5 consecutive days

Drug: compound pholcodine oral solution

Interventions

Huashi Baidu granule DRUG

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.

intervention group

compound pholcodine oral solution DRUG

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.

control group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• attend the COVID-19 Fangcang Shelter Hospitals in Shanghai, China
• with laboratory-confirmed COVID-19
• compliance with the diagnostic criteria for mild COVID-19
• age 3 to 18 years.

You may not qualify if:

• with underlying disease(s) such as chronic pulmonary disease, immunodeficiency, tumors, etc.,
• allergy or intolerance to taking Chinese medicine herbs or compound pholcodine oral solution
• with poor compliance (defined as inability to comply with the protocol)
• decline to participate

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai children's medical center

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jian Gao, MD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

• Yong Yin, MD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 15, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)