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Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations

Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01636154
Enrollment
120
Registered
2012-07-10
Start date
2012-01-31
Completion date
2016-08-31
Last updated
2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation, medicinal fractions-based herbal combinations

Brief summary

The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.

Detailed description

The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.

Interventions

KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

KDZ40ml+0.9%N.S.250ml,ivdrip;0.9%N.S.50ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip.qd of each 14-day cycle.Number of cycles:one.

Sponsors

Shandong University of Traditional Chinese Medicine
CollaboratorOTHER
Huairou Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Yunling Zhang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with acute ischemic stroke * Patients with fire-heat syndrome * Stoke onset within 48 hours * NIHSS scores range from 5 points to 25 points * Age from forty to seventy-five,gender not limited * Informed and signed the consent

Exclusion criteria

* Cardiogenic cerebral embolism,stroke caused by other reasons or the unexplained * Patients suitable for thrombolytic therapy(rt-PA, urokinase) * Patients have received thrombolytic therapy * Patients with serious diseases of heart,lungs,liver,kidneys * Patients with bleeding or bleeding tendency recently * Pregnant or lactating women * Pre-existing neurological or psychiatric diseases that could confound the study results * Patients be allergic to alcohol,Ixeris of sonchifolia Hance components (KDZ injection) or Panax notoginseng saponins components (Xueshuantong injection) * Patients have participated in other clinical trials within 3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026