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CompletedNCT02604654Updated Aug 25, 2021

Effectiveness and Safety of Yiqitongluo Granule for Stroke

A Phase 4 interventional study of Yiqitongluo granule in Stroke, sponsored by Yi Yang. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Yi Yang · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
2,197
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 2,197 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Yi Yang is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • mild and moderate ischemic stroke patient with 4-25 NIHSS score
  • stable patients within 1 week to 3 months
  • sign informed consent before study

Exclusion criteria

Exclusion Criteria:

  • CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage
  • severe disturbance of consciousness
  • dysphagia
  • TIA
  • hemorrhagic diathesis
  • patient with malignant tumor whose expected lifetime is less than 3 months
  • allergic constitution
  • gestation period, lactation period, woman with the possibility or plan of pregnancy
  • those who participated in other clinical trials within 3 months or taking part in other clinical trials
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,197 participants (actual)

Study arms

  • Experimental
    Yiqitongluo group

    Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.

    Drug: Yiqitongluo granule

Interventions

  • DrugYiqitongluo granule

    administered after dissolved

06

What researchers measure

Primary outcomes

  1. Safety of Yiqitongluo for stroke measured by laboratory index

    Time frame: change from baseline laboratory index at 28(±7) days

Secondary outcomes

  1. Effect of Yiqitongluo for stroke with mRS

    mRS: modified Rankin Scale

    Time frame: 90(±7) days

  2. Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine

    Time frame: 28(±7) days

  3. Effect of Yiqitongluo for stroke with NIHSS

    NIHSS: the NIH stroke scale

    Time frame: 28(±7) days

  4. Effect of Yiqitongluo for stroke with BI

    BI: Barthel Index

    Time frame: 28(±7) days

  5. Effect of Yiqitongluo for stroke with EQ-5D

    The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

    Time frame: 28(±7) days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02604654
Lead sponsor
Yi Yang
Collaborators
Shineway Pharmaceutical Co.,Ltd
Responsible party
Yi Yang (Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Nov 13, 2015
Start date
Dec 29, 2015
Primary completion
Nov 5, 2017
Completion
Dec 6, 2017
Last update
Aug 25, 2021

Study contacts

Yi Yang
study chair · The First Hospital of Jilin University
Zhenni Guo
study director · The First Hospital of Jilin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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