A Phase 4 interventional study of AICH-PXZY and AICH-without PXZY in Intracerebral Hemorrhage, Hypertensive and Traditional Chinese Medicine, sponsored by Guangzhou University of Traditional Chinese Medicine. Status unknown at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-27.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Phase 4, Interventional, and Treatment
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Among 11 studies in Intracranial Hemorrhage, Hypertensive with a site in China — 4 open to participants now, 4 under way, none of them phase 3. Intracranial Hemorrhage, Hypertensive · China.
Among the 11 studies in Intracranial Hemorrhage, Hypertensive with a site in China, this one is the 6th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2017, is the only one in phase 4, and was the 6th registered.
23 studies on the registry are indexed under Intracranial Hemorrhage, Hypertensive; 8 are open to participants now.
Browse Intracranial Hemorrhage, Hypertensive studies →4 of the 11 studies in Intracranial Hemorrhage, Hypertensive with a site in China are open now. Recruiting first, the newest first:
RenJi Hospital · Sites in China
Ages 16–65
Xuanwu Hospital, Beijing · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18–80
Shanghai Changzheng Hospital · Sites in China
Ages 15–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1 Intracranial Hemorrhage, Hypertensive study recruiting now, none set no upper age limit and 1 stops at 75 or younger; 1 takes children under 18; none take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 306 is close to the median of 306 across 17 interventional studies indexed under Intracranial Hemorrhage, Hypertensive.
Median enrollment 353 across the 10 interventional studies, 10 across the 1 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 10 most frequent:
Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 58 studies on the registry; 19 are open to participants now.
Guangzhou University of Traditional Chinese Medicine has 2 studies filed under Intracranial Hemorrhage, Hypertensive — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Intracranial Hemorrhage, Hypertensive with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Removing Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Drug: AICH-PXZY · Drug: AICH-without PXZY · Drug: AICH-placebo
Removing Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Drug: AICH-PXZY · Drug: AICH-without PXZY · Drug: AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Drug: AICH-PXZY · Drug: AICH-without PXZY · Drug: AICH-placebo
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
Also known as: herbal medicine with Hirudo, Tabanus
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
Also known as: herbal medicine without Hirudo, Tabanus
The placebo is made up of Starch, bitter taste and cyclodextrin
Also known as: Placebo
Hematoma enlargement
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)
Time frame: 6-72h within onset, 24hrs, 10-14days
GCS scoring scale
The Glasgow score was used to assess the coma index.
Time frame: 6-72hours within onset, 24hours later, 3 months
National Institute of Health of stroke scale
The NIHSS is for evaluation of neurological deficits.
Time frame: 6-72hours within onset, 24hours later, 3 months
BI index
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.
Time frame: 3 months
Social function activity questionnaire(FAQ)
FAQ is mainly to know the quality of life and living habits of the patients and their families.
Time frame: 3 months
fatality rate
Any cause of death within the entire treatment 10ds and follow-up 90ds.
Time frame: 3 months
modified rankin scale
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.
Time frame: 3 months
Plan to share: Undecided — We will keep the IPD in secret and share that only when the agreement are shown by the Ethics committee and the project committee，including the examination results, genotype, etc.
Start is estimated for Nov 2017; primary completion for Dec 2022, 61 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Intracranial Hemorrhage, Hypertensive →
Guangzhou University of Traditional Chinese Medicine