Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy (CERBSTTSCH)

Guangzhou University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 4

Conditions: Traditional Chinese Medicine; Intracerebral Hemorrhage, Hypertensive

Treatments: Drug: AICH-without PXZY; Drug: AICH-PXZY; Drug: AICH-placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03354026

JDZX2015048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 3 patient groups, including a placebo group

Experimental: AICH-PXZY

Experimental group

Description:

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).

Treatment:

Drug: AICH-placebo

Drug: AICH-PXZY

Drug: AICH-without PXZY

Experimental: AICH-without PXZY

Experimental group

Description:

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).

Treatment:

Drug: AICH-placebo

Drug: AICH-PXZY

Drug: AICH-without PXZY

Placebo: AICH-placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: AICH-placebo

Drug: AICH-PXZY

Drug: AICH-without PXZY