Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
CERBSTTSCH
1 other identifier
interventional
306
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2017
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedNovember 27, 2017
November 1, 2017
5.1 years
November 10, 2017
November 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
6-72h within onset, 24hrs, 10-14days
Secondary Outcomes (6)
GCS scoring scale
6-72hours within onset, 24hours later, 3 months
National Institute of Health of stroke scale
6-72hours within onset, 24hours later, 3 months
BI index
3 months
Social function activity questionnaire(FAQ)
3 months
fatality rate
3 months
- +1 more secondary outcomes
Study Arms (3)
Experimental: AICH-PXZY
EXPERIMENTALRemoving 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).
Experimental: AICH-without PXZY
EXPERIMENTALRemoving 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).
Placebo: AICH-placebo
PLACEBO COMPARATORThe 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).
Interventions
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
The placebo is made up of Starch, bitter taste and cyclodextrin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangzhou University of Traditional Chinese Medicinelead
- Lianjiang people's Hospitalcollaborator
- Shenyang Second Hospital of traditional Chinese Medicinecollaborator
- The Third People's Hospital of Hubei Provincecollaborator
- Liaocheng People's Hospitalcollaborator
- Zengcheng Hospital of traditional Chinese Medicinecollaborator
- Shouguang people's Hospitalcollaborator
Study Sites (2)
Guangdong Provincial Science and Technology Agency
Guangzhou, Guangdong, 510033, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Related Publications (1)
Zhang Q, Zeng L, Chen X, Zhou Y, Gong B, Li H, Guo J. Clinical Evaluation of Herbal Medicine (ICH-012) in Treating Acute Cerebral Haemorrhage: Safety and Efficacy from 6- to 72-Hour Time Window (CRRICHTrial-II). Evid Based Complement Alternat Med. 2018 Aug 26;2018:3120179. doi: 10.1155/2018/3120179. eCollection 2018.
PMID: 30224926DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 27, 2017
Study Start
November 1, 2017
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
November 27, 2017
Record last verified: 2017-11