NCT01758536

Brief Summary

The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

December 24, 2012

Last Update Submit

January 18, 2013

Conditions

Ischemic Stroke

Keywords

ischemic strokeneural functionlife quality

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale

    The primary end point is the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months.

    3 months

Secondary Outcomes (1)

  • modified Rankin Scale,NIHSS, Barthel Index, and MMSE

    3 months

Other Outcomes (1)

  • Traditional Chinese Symptoms and tongue image

    the first day of enrollment

Study Arms (2)

Placebo Pills

PLACEBO COMPARATOR

* 12 g each time, twice daily. * 3 months

Drug: Huatuo Zaizao Pills

Huatuo Zaizao Pills

EXPERIMENTAL

* 12 g each time, twice daily. * 3 months.

Drug: Huatuo Zaizao Pills

Interventions

Huatuo Zaizao PillsDRUG

A tens of herbs botanical drug product 12 gram (g) in 72 mini pills formulation. It is to be used as 12 g each time, twice daily.

Also known as: Huatuo Zaizao Wan
Huatuo Zaizao PillsPlacebo Pills

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be between the ages of 18 and 70 years.
  • Patient must be with ischemic stroke and at stroke onset 14th day.
  • Patient must be with mRS score \<5 at enrollment and mRS score ≤1 before stroke onset.
  • Symptoms and imaging of CT (computed tomography) or MRI (Magnetic Resonance Imaging) support the diagnosis of ischemic stroke.
  • Patient must be with 4 ≤ NIHSS ≤16.
  • Patient must be with Glasgow coma scale (GCS) ≥7.
  • Only patient with an anterior circulation infarction of Oxfordshire Community Stroke Project (OCSP)classification and atherothrombosis or cardioembolism of modified TOAST classification were accepted.
  • Patient must understand and be willing, able and likely to comply with all study requirements.
  • Informed consent must be obtained.

You may not qualify if:

  • Patient with severe cognitive impairment who not be able to give voluntary written informed consent or participate in this study.
  • Maybe not to comply with all study requirements or not be able to participate in this study for regional or social reasons.
  • Pregnancy, breast feeding and the possible pregnancy during study.
  • Participating in another medicine or interference study in the same time or at least within 3 months, or enrolled in this study in other location.
  • Patient with mRS≥5 at enrollment.
  • Coma patient with GCS\<7.
  • Patient with severe cerebral function impairment which was not caused by stroke.
  • Patient with dysphagia, Wyatt score ≥2.
  • Lacunar infarction.
  • Patient accompanied with systemic diseases: gastrointestinal hemorrhage, advanced carcinoma, liver malfunction, kidney malfunction, severe dementia or mental disorder.
  • Unstable patient after receiving thrombolytic therapy.
  • Cerebral hemorrhage verified by CT or MRI.
  • History of major operation or trauma within 6 weeks or having a major operation arrangement.
  • Allergic to one or more components of study medicine.
  • Receiving study medicine or components of study medicine within 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

Shanghai Tenth People's Hospital

Shanghai, 200072, China

ACTIVE NOT RECRUITING

Shanghai First People's Hospital

Shanghai, 200081, China

ACTIVE NOT RECRUITING

Shanghai Shuguang Hospital

Shanghai, 201203, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Qiang Dong, MD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng-yu Lu, MD

CONTACT

8613817912099luzhengyu@yahoo.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 24, 2012

First Posted

January 1, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

CN(4)