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

Yunling Zhang

Status: Completed

Conditions: Ischemic Stroke

Treatments: Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins; Drug: Panax notoginseng saponins; Drug: Ixeris of sonchifolia Hance

Study type: Interventional

Funder types: Other

Identifiers

NCT01636154

BUCMDFH9634

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

120 participants in 4 patient groups

The basic treatment

No Intervention group

Description:

Comply to the Chinese guidelines of acute ischemic stroke in 2010

Clearing heat

Other group

Description:

Treat with KDZ injection on the basis of the basic treatment

Treatment:

Drug: Ixeris of sonchifolia Hance

Promoting blood circulation

Other group

Description:

Treat with Xueshuantong injection on the basis of the basic treatment

Treatment:

Drug: Panax notoginseng saponins

Clearing heat & Promoting blood circulation

Experimental group

Description:

Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment

Treatment:

Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins