CClinicalTrials.gg
Sign In
CompletedNCT00351806Updated Aug 7, 2013

AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine

A Phase 4 interventional study of Erigeron breviscapus injection and hua tuo zai zao wan (a herbal medicine pill) in Cerebral Infarction, sponsored by Guangzhou University of Traditional Chinese Medicine. Completed at 22 sites in China. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by Guangzhou University of Traditional Chinese Medicine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety.

Read the detailed description

The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and safety.

02

Conditions studied

  • Cerebral Infarction

Keywords

  • acute intracerebral infarction
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's enrollment of 500 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ischemic stroke diagnosis by CT/MRI scan
  • Yin pattern of Traditional Chinese Medicine Theory
  • 40-85 years old
  • Total anterior circulation infarcts (TACI), partial anterior territory cerebral infarction (PACI), lacunar anterior circulation infarcts (LACI) type under Oxfordshire Community Stroke Project (OCSP) standard
  • NIHSS >=4;
  • Glasgow coma scale (GCS) >=7;
  • Modified Rankin Scale less than 2 degrees before onset of this stroke
  • Informed consent signed by patient or his/her family

Exclusion criteria

Exclusion Criteria:

  • Hemorrhagic stroke;
  • Coma, GCS\<=7;
  • Cerebral hernia;
  • Serious heart, liver, lung, kidney functional failure;
  • Gastrointestinal (GI) bleeding;
  • Thrombolysis drugs or surgery was administrated to the patient;
  • Not cooperative with physician;
  • Psychological disorder;
  • Already taken part in other clinical drug trial within the past 3 months
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
500 participants

Study arms

  • Experimental
    Chinese herbal medicine

    Drug: Erigeron breviscapus injection · Drug: hua tuo zai zao wan (a herbal medicine pill) · Drug: Compound stroke herbal medicine (8 herbal)

  • Placebo comparator
    placebo

Interventions

  • DrugErigeron breviscapus injection
  • Drughua tuo zai zao wan (a herbal medicine pill)
  • DrugCompound stroke herbal medicine (8 herbal)
06

What researchers measure

Primary outcomes

  1. death rate, Barthel Index

Secondary outcomes

  1. Glasgow Outcome Scale (GOS)

  2. Modified Rankin Scale (mRS)

  3. National Institute of Health Stroke Scale (NIHSS)

  4. Stroke Specific Quality of Life (SSQOL)

  5. Scale of Traditional Chinese Medicine (SSTCM)

07

Study locations

22 sites
  • Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
    Beijing, Beijing 100700, China
  • Foshan Hospital of Traditional Chinese Medicine
    Foshan, Guangdong 528000, China
  • 2nd hospital of Zhongshan University
    Guangzhou, Guangdong 510120, China
  • Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
    Guangzhou, Guangdong 510120, China
  • Zhongshan Hospital of Traditional Chinese Medicine
    Zhongshan, Guangdong, China
  • Ruikang Hospital of Traditional Chinese Medicine
    Nan Ning, Guangxi 530011, China
  • 1st Hospital of Guangxi college of Traditional Chinese Medicine
    Nanning, Guangxi 530023, China
  • The 1st Hospital of He'nan College of Traditional Chinese Medicine
    Zhengzhou, Henan 450006, China
  • The teahing hospital of Hubei College of Traditional Chinese Medicine
    Wuhan, Hubei 430006, China
  • Taizhou Hospital of Traditional Chinese Medicine
    Taizhou, Jiangsu, China
  • Jinan Hospital of Traditional Chinese Medicine
    Jinan, Shandong, China
  • Longhua Hospital of Shanghai University of Traditional Chinese Medicine
    Shanghai, Shanghai 200000, China
  • Shanghai Hospital of Traditional Chinese Medicine
    Shanghai, Shanghai 200000, China
  • Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
    Shanghai, Shanghai 200000, China
  • Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
    Shanghai, Shanghai 200000, China
  • zhongshan hospital of Fudan Unversity
    Shanghai, Shanghai 200032, China
  • Huashan Hospital of Fudan Unveristy
    Shanghai, Shanghai 200040, China
  • The Hosptial of Shanxi College of Traditional Chinese Medicine
    Xian yang, Shanxi 712000, China
  • The People's Hospital of Sichuan Province
    Chengdu, Sichuan 610072, China
  • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
    Urumqi, Xinjiang 830001, China
  • Zhejiang Province Hospital of Traditional Chinese Medicine
    Hangzhou, Zhejiang, China
  • The 2nd Hospital of Wenzhou Medical College
    Wenzhou, Zhejiang, China
08

References and documents

Publications

  • Huang Y, Guo JW; Project Group for Demonstration Study of Syndrome Differentiation Protocol and Effect Evaluation of Acute Ischemic Stroke. Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke. Zhong Xi Yi Jie He Xue Bao. 2010 May;8(5):417-26. doi: 10.3736/jcim20100504. PubMed 20456839 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00351806
Lead sponsor
Guangzhou University of Traditional Chinese Medicine
First posted
Jul 13, 2006
Start date
Jul 2005
Completion
Nov 2006
Last update
Aug 7, 2013

Study contacts

Longhui Yang, Chairmam
study chair · Branch of Science and Education
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Ischemic Stroke→

Other studies from this sponsor

Guangzhou University of Traditional Chinese Medicine

Start the discussion