One Research on Improving Cognitive Impairment Caused by Hypertension

Hypertension Clinical Trial

Official title:

One Research on Application of Key Technologies About Improving Cognitive Impairment Caused by Hypertension With the Therapy of Early Intervention With Qianyang Yuyin Granules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03943420
• Other study ID #: BE2017770
• Status: Recruiting
• Start date: December 28, 2018
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: Cheng Chang, PhD
• Phone: +8613851821996
• Email: chch1967[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.

Description:

Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.

The investigators designed a multi-center randomized controlled clinical trial to study the security and effectiveness of this therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 55 to 75 years old, male or female;

• Having a history of hypertension for more than 2 years but can maintain SBP = 140 mmHg and BDP = 90 mmHg with medication;

• 21 = MMSE < 26, or 14 = MoCA < 26, CDR < 0.5. Bseides, the chief complaint must happen after having hypertension;

• Meet TCM Syndrome Differentiation Standard:according to the Guidelines for the Clinical Research of Chinese Medicine New Drugs ( published by China Medical Science Press ) :Overabundant liver-fire type:dizziness and headache, both face and eyes are red, dry mouth and bitter taste in mouth, red tongue with yellowish coating, wire and frequent pulse. Yin deficiency and yang hyperactivity type: dizziness and headache, Tinnitus and forgetfulness, sphoria with feverish sensation in chest & palms & soles, palpitation and insomnia, red tongue & thin white or less coating, wiry weak and numbered pulse;

• CTMRI hint: leukoaraiosis and no sign of Cerebral infarction;

• Patients or the guardian hold the right opinions over the research and are willing to obey researcher's orders;

• Having a certain degree of education (being able to read simple newspapers in the past);

• Patients agree to sign informed consent?

Exclusion Criteria:

• Secondary hypertension;

• Taking certain kinds of antihypertensive drugs which may damage brain cognitive function;

• Diagnosed as depression or other mental disorders according to DSM-IV;

• Diagnosed as vascular dementia according to diagnostic criteria, CDR = 0.5; alzheimer disease or dementia caused by some other reasons (including mixed dementia according to diagnostic criteria for VCI); cognitive impairment due to head injury?

• Suffering from certain kinds of diseases which may interfere the assessment of cognitive function, including those who are diagnosed as alcoholics and drugs or psychotropic medicine abusers during the last 5 years according to DSM-IV;

• Accompanied with severe neurological function disorder;

• Asthma, chronic severe primary cardiovascular disease, liver lesion, hematological lesions, lung diseases, diabetes or other severe diseases may influence the patients' survival such as cancer or AIDS;

• Other: Such as poor compliance, or can not attend the follow-up visit in time for some reasons;

• Taking the same kind of medicine during the last 30 days which may influence the trial;

• Is participating in another clinical study;

• Not up to TCM Syndrome Differentiation Standard?

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hypertension

Locations

Country	Name	City	State
China	Jiangsu Province Hospital of Chinese Medcine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Famous Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of brain image	Measure and record the volume changes of diseased alba, the micro-structure changes of alba fasciculus by MRI to see if the therapy effect or not.	24 weeks
Primary	Measure and assess the changes of VaDAS-cog ( Vascular Dementia Assessment Scale cognitive subscale ) among time points	Measure and record with VaDAS-cog	12 weeks, 24 weeks, 48 weeks
Secondary	Measure and assess the changes of MMSE ( Mini-mental State Examination ) among time points	Measure and record with MMSE	12 weeks, 24 weeks, 48 weeks
Secondary	Measure and assess the changes of ADL ( Activity of Daily Living ) among time points	Measure and record with ADL	12 weeks, 24 weeks, 48 weeks
Secondary	Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points	Measure and record with CDR	12 weeks, 24 weeks, 48 weeks
Secondary	Incidence rate of outcome event	Record the outcome event and analyse the incidence rate	24 weeks
Secondary	Therapeutic effect	Measure and record patients' systolic and diastolic blood pressure and analyse related data	24 weeks
Secondary	Metabonomics	Measure and record the metabonomics ( Trx & TrxR ) index	24 weeks