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Getong Tongluo capsules for the treatment of ischemic stroke with concomitant recovery of primary hypertension (grade 1) (combined stasis and blood stasis syndrome) safety and efficacy of randomized, double-blind, positive and placebo-controlled, multi- Center clinical trial

Getong Tongluo capsules for the treatment of ischemic stroke with concomitant recovery of primary hypertension (grade 1) (combined stasis and blood stasis syndrome) safety and efficacy of randomized, double-blind, positive and placebo-controlled, multi- Center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016667
Enrollment
Unknown
Registered
2018-06-14
Start date
2015-05-14
Completion date
Unknown
Last updated
2018-06-18

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

Conditions

Ischemic Stroke with Recovery of Essential Hypertension (Grade 1)

Interventions

test group:Getong Tongluo capsules
Ginkgo biloba extract tablet simulator
Positive control drug group:Ginkgo biloba extract tablets
Getong Tongluo Capsules Simulator
placebo group:Getong Tongluo Capsules Simulator, Ginkgo biloba extract tablet simulator

Sponsors

Dongfang Hospital of Beijing University of Chinese Medicine; Xiangya Hospital Central, South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who accord with Western diagnostic criteria for ischemic stroke (anterior circulation patients ); 2. Patients with primary hypertension (Grade 1) Western medicine diagnostic criteria; 3. Patients with the diagnosis of traditional Chinese medicine blood stasis syndrome; 4. Patients with onset time within 2 weeks and within 3 months; 5. NIHSS score = 6 and = 22; 6, aged 18-75 years old; 7. Patients with first-episode or recurrent stroke have completely recovered their patients before the onset of the disease, and their mRS score is 0-1; 8. Those who signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. A history of intracerebral hemorrhage (including subarachnoid hemorrhage) in the past half years; 2. Patients with clinically-derived cardiac infarction and other definite and unexplained types; 3. It has been confirmed by examination that cerebral infarction, brain trauma, cerebral parasitosis, metabolic disorders, rheumatic heart disease, coronary heart disease, and other heart diseases have cerebral thrombosis caused by thrombosis of atrial fibrillation associated with atrial fibrillation.; 4. Incorporate other functional disorders that affect physical activity, such as combined lameness, osteoarthritis (active phase), rheumatoid arthritis (active phase), gouty arthritis, and other limb activity dysfunction may affect neurological or functional testers; 5.Patients with diabetic complications (eg, severe diabetic nephropathy leading to renal insufficiency, diabetic peripheral neuropathy affecting motor function assessor, diabetic ketoacidosis, etc.) and patients with recurrent hypoglycemia; 6. Patients with severe malnutrition and severe hematological diseases (such as hypoalbuminemia, severe anemia, etc.) and serious electrolyte disturbances cannot be corrected after treatment; 7. Patients with severe heart and lung system diseases and chronic liver and kidney dysfunction, among which liver function damage ALT, AST > 1.2 times the upper limit of normal, renal function creatinine (Cr)> normal upper limit; 8, pregnant or lactating women; 9. Patients with disabilities prescribed by law (blind, deaf, dumb, intellectual disabilities, mental disorders, physical disabilities); 10. Known to allergies and allergies to the drug ingredients; 11. The researcher believes that there are any patients who are not suitable for inclusion or influence the factors that participate in or complete the study; 12. Patients who participated in other clinical trials within 12 or 3 months.

Design outcomes

Primary

MeasureTime frame
MRS;MRS;BI;

Secondary

MeasureTime frame
NIHSS;SBP;DBP;Rate of BP;Incidence of cardiovascular and cerebrovascular events (stroke, myocardial infarction, TIA, cerebral hemorrhage, death, etc.Incidence of cardiovascular and cerebrovascular events (stroke, myocardial infarction, TIA, cerebral hemorrhage, death, etc.;TCM symptom score;Four lipids and glycosylated hemoglobin improvement;

Countries

China

Contacts

Public ContactChen Zhigang;Liu Yunhai

Dongfang Hospital of Beijing University of Chinese Medicine/Xiangya Hospital Central South University

13601275206@139.com+86 010-67689655; 0731-84328888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026