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Naotai Fang for prevention and treatment of hypertensive cerebral small vessel disease: randomized, double-blind, placebo-controlled, multi-center clinical trial protocol

Study for the prevention and treatment of hypertensive cerebral small vessel disease by Naotaifang

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024524
Enrollment
Unknown
Registered
2019-07-13
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Hypertension-induced cerebral small vessel disease

Interventions

Sponsors

Hu'nan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Agec between 40-80 years old; 2. Compliance with patients with essential hypertension; 3. According to the "General Consensus of Diagnosis and Treatment of Cerebral Small Vascular Diseases", MRI confirmed cerebral small vessel disease, but yes or no clinical manifestations of brain damage; 4. TCM syndrome differentiation standard: refer to the Interpretation of TCM Clinical Diagnosis and Treatment Guidelines. Syndrome based on wind-phlegm stagnant blood syndrome; 5. Voluntary participation in the trial and signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious life-threatening diseases such as acute myocardial infarction, stroke, cardiac insufficiency, grade IV, etc; 2. Imaging and other diseases to exclude hypertensive cerebral small vessel disease; 3. Hypertension can not be controlled by using antihypertensive drugs; 4. Patients with cerebral macrovascular disease; 5. Allergic or research drug known to be allergic to ingredients; 6. Suspected or indeed have a history of alcohol or drug abuse, or according to the judgment of the investigator, other lesions or conditions that reduce the likelihood of enrollment or complicate the enrollment, such as frequent changes in the working environment and unstable living environment, may cause loss of follow-up Case; 7. Suffering from any serious psychological abnormalities and mental disorders, unable to comply with clinical research procedures and norms, and other researchers believe that it is not suitable for inclusion; 8. Preparing a pregnant or lactating woman within one or six months of pregnancy; 9. Patients who are participating in other clinical trials or have participated in other clinical trials in the past month.

Design outcomes

Primary

MeasureTime frame
MRI (The number of craniocerebral, the number of microbleeds, the Fazekas score, and the grading criteria for the severity of d VRS in different brain regions);

Secondary

MeasureTime frame
blood pressure;TCM syndrome points;

Countries

China

Contacts

Public ContactGe Jinwen

Hunan University of Chinese Medicine

40831556@qq.com+86 13873172948

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026