One Research on Improving Cognitive Impairment Caused by Hypertension

Study Overview
=================
Brief Summary
-----------------
Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.

Detailed 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.

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

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
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。

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group<br>Therapy A : Basic treatment + Qianyang Yuyin Granules | |
| Negative Control Group<br>Therapy B : Basic treatment | |
| Positive Control Group<br>Therapy C : Basic treatment + Donepezil | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points | Measure and record with CDR | 12 weeks, 24 weeks, 48 weeks | 
| Incidence rate of outcome event | Record the outcome event and analyse the incidence rate | 24 weeks | 
| Therapeutic effect | Measure and record patients' systolic and diastolic blood pressure and analyse related data | 24 weeks | 
| Metabonomics | Measure and record the metabonomics ( Trx & TrxR ) index | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Effectiveness, Therapy, Qianyang Yuyin Granules, Cognitive impairment, Hypertension