MedTrace Logo

Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia

NCT04275219 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2020-09-07

No results posted yet for this study

Summary

Stroke-associated pneumonia (SAP) is the major complication of acute intracerebral haemorrhage (AICH), leads to poor clinical outcomes and increases the financial burden on the medical system. Prophylactic antibiotics do not reduce the mortality rate of SAP. The Tong-Fu-Xing-Shen herbal formula (TFXS) was shown to be effective for the prevention and treatment SAP in a previous clinical trial. To clarify whether TFXS is effective and safe for the treatment of SAP and affects the immunological mechanism of the "brain-gut-lung" pathway of SAP, the investigators designed this study.

Conditions

Interventions

DRUG

Tongfu capsules

Tongfu capsules include 5 herbals

DRUG

The Placebo of Tongfu capsules

The Placebo of Tongfu capsules are made from dextrin, starch and so on.

Sponsors & Collaborators

  • People's Hospital of Ganzhou City

    collaborator UNKNOWN

  • People's Hospital of Lianjiang City

    collaborator UNKNOWN

  • Yangjiang Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Shenyang No. 2 Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Guangzhou University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04275219 on ClinicalTrials.gov