Intracerebral Hemorrhage, Hypertensive, Traditional Chinese Medicine
Conditions
Keywords
Blood-breaking Decotion
Brief summary
The purpose of this research is to use the Removing Blood Stasis Decotion of traditional Chinese medicine treating the acute stage of cerebral hemorrhage with stroke associated pneumonia to explore the impact of Removing Blood Stasis Therapy on intestinal microbial flora either within the time window from 6 to 72 hours onset.
Detailed description
objective: to investigate the impact and immunologic mechanism of using the Removing Blood Stasis Decotion treatment in SAP after Acute Cerebral Hemorrhage with the concept of Intestinal Micro Ecological Regulation. Methods: from 2017.01 to 2022.12, 240 cases of AICH, 306 cases of hypertension will be included in 7 research centers. The AICH patients are randomly into 3 groups within 6 to 72hrs from onset, thus there are 3 groups and the treatment will last for 10 days: group A，Removing Blood Stasis herbal medicine(8 herbals); Group B, herbal medicine without Poxuezhuyu activating herbal(6 herbals); Group C, placebo medicine of Chinese medicine.All the patients will be treated according AHA guideline of AICH and will be set to the brain CT and chest X-ray at the onset, 24h later and 10-14days after treatment. The venous blood，feces Specimen and the sputum will be collected in the time point of 6 to 72hrs within onset , 24h later, and 10-14days after treatment.So the rate of enlargement of brain hematoma and the development of SAP in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.
Interventions
DRUGAICH-PXZY
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
DRUGAICH-without PXZY
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
DRUGAICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Sponsors
Lianjiang people's Hospital
Shenyang Second Hospital of traditional Chinese Medicine
The Third People's Hospital of Hubei Province
Liaocheng People's Hospital
Zengcheng Hospital of traditional Chinese Medicine
Shouguang people's Hospital
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Our randomized program was completed by the key research laboratory of clinical research from the Traditional Chinese medicine Hospital of Guangdong Province. We design 306 cases into three groups: Group A, B, C in the proportion of 1:1:1. Group A is the experimental group used RBS, which include 8 herbals. Group B is the experimental group used PBS, which include all the herbals in Group A except Leech and Tabanus, rhubarb. Group C is a placebo group. This study adopts a stratified random sampling method and intra slice randomization on the basis of using PROC PLAN progress on SAS V9.2. On the other hand, this trial measures and the control measures will be made blind doubly. The surface of the opaque random envelopes will indicate the information of the test name, hospital name and the entry sequence number of patient. The research process of incorporating patient, dispensing medicine depending on the random envelopes and ect will all be supervised by the researchers each other.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 18 years old while younger than 80 years old * acute cerebral hemorrhage confirmed by brain CT scan within 6 to72 hours from onset * GCS≥6 * Sign the informed consent form
Exclusion criteria
* Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc; * patients with Severe heart, liver and renal insufficiency. * Intolerance to traditional Chinese medicine (TCM), allergic constitution. * patients with severe cerebral hernia in the early onset * Compliance is poor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma enlargement | 6-72h within onset, 24hrs, 10-14days | The hematoma volume enlarged 33% or increased 12.5ml defined as hematoma enlargement which are compared with the two CT scans(6-72h within onset and 24h after onset,or 6-72h within onset and 10-14days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Health of stroke scale | 6-72hours within onset, 24hours later, 3 months | The NIHSS is for evaluation of neurological deficits. |
| BI index | 3 months | BI index \<90 defines life cannot be independent. The percentage of BI 100-90 points in the three groups was statistically followed up by 90ds. |
| GCS scoring scale | 6-72hours within onset, 24hours later, 3 months | The Glasgow score was used to assess the coma index. |
| fatality rate | 3 months | Any cause of death within the entire treatment 10ds and follow-up 90ds. |
| modified rankin scale | 3 months | Scoring 2-5 is defined as disability, which can be divided into 4 grades: mild, moderate, severe and severe. The percentage of mRS 0-1 points in the three groups will be statistically followed up by 90ds. |
| Social function activity questionnaire(FAQ) | 3 months | FAQ is mainly to know the quality of life and living habits of the patients and their families. |
Countries
China
Contacts
Primary ContactJianwen J Guo, Doctor
Backup ContactQixin Q Zhang, Master
Outcome results
None listed