A Phase 4 interventional study of Tongfu capsules and The Placebo of Tongfu capsules in Stroke and Complication, sponsored by Guangzhou University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-09-07.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Phase 4, Interventional, and Treatment
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.
This is a multicentre, randomized, double-blind, placebo-controlled clinical trial. A total of 218 patients will be recruited and randomly assigned to the experimental group (EG) or the control group (CG) in a 1:1 ratio. The treatment course will be 10-12 consecutive days, with a 90±7-day follow-up. The primary outcome is the all-cause mortality rate and the mortality of pneumonia at the 90±7-day follow-up. Secondary outcomes include changes in the gut microbiota; changes in the NIHSS score, BI index, mRS score, and Stroke-Specific Quality of Life scale (SS-QOL) score; and so on.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 218 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For inclusion, participants will need to fulfil all the following criteria:
Exclusion criteria
Participants with any of the following conditions will be excluded:
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 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
Tongfu capsules include 5 herbals
The Placebo of Tongfu capsules are made from dextrin, starch and so on.
the all-cause mortality rate
Any cause of death
Time frame: 90±7 days
the mortality of stroke associated pneumonia
the death of stroke associated pneumonia
Time frame: 90±7 days
changes in the gut microbiota between the experiment group and the control group
gut microbiota is monitored via 16S rRNA gene sequence analysis
Time frame: Baseline (before drug), after drug 10-12 days
National Institute of Health of stroke scale （NIHSS）
The NIHSS is for evaluation of neurological deficits. The NIHSS includes the following domains: level of conscious-ness, eye movements, integrity of visual fields, facial movements,arm and leg muscle strength, sensation, coordination, language,speech and neglect. Each impairment is scored on an ordinal scaleranging from 0 to 2, 0 to 3, or 0 to 4. The scoing of it ranges from 0 to 42. The higher scoring represents the more serious nerve defects. The scoring from 0-1 are normal or close to normal, 2-4 are mild, 5-15 are moderate, 6-20 are medium and severe and more than 20 points are severe neurological dysfunction.
Time frame: Baseline (before drug), after drug 10-12 days, 90±7 days
Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke.It consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity (UE) function, vision, and work/productivity. The score ranges from 0 to 100. The higher the score, the better the quality of life.
Time frame: 90±7 days
Barthel index
The score ranges from 0 to 100. It represents the self-care ability. BI index ≤40 defines heavily dependent, ranges from 41 to 60 defines moderate dependent, ranges from 61 to 99 defines mild dependent and 100 defines independent. The scoring ≥\<90 defines life cannot be independent. The percentage of BI 100-90 points in the three groups was statistically followed up by 90ds. The higher scoring represents a better outcome. There are 4 evaluation grades for 10 aspects(complete independence，part of the help, great help, absolutely dependent).The 10 aspects of the BI index includes eating(10,5,0,0), washing(5,0,0,0), making up（5,0,0,0）, dressing up(10,5,0,0），control of the stool(10,5,0,0), control of the urination(10,5,0,0), going to toilet(10,5,0,0), bed-chair transform(15,10,5,0), walking on the ground(15,10,5), going up and down the stairs(10,5,0,0).
Time frame: Baseline (before drug), after drug 10-12 days, 90±7 days
Modified rankin scale (mRS)
It represents the recovery of neural functions. The scoring ranges from 0 to 5. Scoring 2-5 is defined as disability, which can be divided into 4 grades: mild, moderate, severe and severe.
Time frame: after drug 10-12 days, 90±7 days
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Guangzhou University of Traditional Chinese Medicine