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

NCT04275219 | Unknown Phase 4 DMC

• 1 other identifier: 001/20180101
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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

Stroke; Complication

Keywords

stroke-associated pneumonia; Tong-Fu-Xing-Shen herbal formula; Traditional Chinese medicine; Brain-gut-lung axis; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• the all-cause mortality rate

  Any cause of death

  90±7 days

• the mortality of stroke associated pneumonia

  the death of stroke associated pneumonia

  90±7 days

Secondary Outcomes (5)

• changes in the gut microbiota between the experiment group and the control group

  Baseline (before drug), after drug 10-12 days

• National Institute of Health of stroke scale （NIHSS）

  Baseline (before drug), after drug 10-12 days, 90±7 days

• Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score

  90±7 days

• Barthel index

  Baseline (before drug), after drug 10-12 days, 90±7 days

• Modified rankin scale (mRS)

  after drug 10-12 days, 90±7 days

Study Arms (2)

Tong-Fu-Xing-Shen herbal formula

EXPERIMENTAL

Tong-Fu-Xing-Shen herbal formula prescription (0.4g\*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12days.

Drug: Tongfu capsules

The Placebo of Tong-Fu-Xing-Shen herbal formula

PLACEBO COMPARATOR

The Placebo of Tong-Fu-Xing-Shen herbal formula prescription (0.4g\*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12 days.

Drug: The Placebo of Tongfu capsules

Interventions

Tongfu capsules DRUG

Tongfu capsules include 5 herbals

Tong-Fu-Xing-Shen herbal formula

The Placebo of Tongfu capsules DRUG

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

The Placebo of Tong-Fu-Xing-Shen herbal formula

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of intracerebral haemorrhage according to 2019 Chinese guidelines for the diagnosis and treatment of acute intracerebral haemorrhage \[9\], with a CT scan of the brain confirming acute intracerebral haemorrhage;
• Age between 18 and 85;
• A diagnosis of SAP according to the modified CDC standard \[10\];
• Within 7 days after stroke onset; and
• Willingness to participate and to sign the informed consent form.

You may not qualify if:

• Participants with any of the following conditions will be excluded:
• Cerebral haemorrhage is confirmed by examination to be caused by a brain tumour, brain trauma, blood disease, cerebrovascular malformation (a congenital abnormality) or aneurysm;
• Cerebral herniation;
• A GCS score \<7;
• Any antibiotic treatment within 4 weeks before the start of the study;
• Pulmonary tuberculosis, pulmonary oedema, pulmonary embolism, noninfectious pulmonary oedema or respiratory circulation failure;
• Liver or kidney function parameters (such as alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[Cre\]) 3 times higher than the upper limit of normal;
• A clear history of gastrointestinal diseases, such as gastrointestinal tumours and inflammatory bowel disease, or a gastrointestinal bleeding period within 3 months;
• Immune-related diseases, such as SLE, rheumatoid arthritis, and Sjogren's syndrome, or receiving immunotherapy for other diseases; and
• Unsuitable for the trial as decided by the researchers.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• People's Hospital of Ganzhou City: collaborator
• People's Hospital of Lianjiang City: collaborator
• Yangjiang Hospital of Traditional Chinese Medicine: collaborator
• Shenyang No. 2 Hospital of Traditional Chinese Medicine: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jianwen Guo, doctor

CONTACT

0086-13724899379; jianwen_guo@msn.com

jianwen Guo, MD

CONTACT

(08620)81887233; 306247680@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 19, 2020
• Study Start: March 15, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 7, 2020

Record last verified: 2020-05

Locations

CN (1)