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One Research on Improving Cognitive Impairment Caused by Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943420
Recruitment Status : Unknown
Verified April 2019 by Jiangsu Famous Medical Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu Famous Medical Technology Co., Ltd.

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

Condition or disease
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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 144 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
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
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Experimental Group
Therapy A : Basic treatment + Qianyang Yuyin Granules
Negative Control Group
Therapy B : Basic treatment
Positive Control Group
Therapy C : Basic treatment + Donepezil


Outcome Measures
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Primary Outcome Measures :
  1. Changes of brain image [ Time Frame: 24 weeks ]
    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.

  2. Measure and assess the changes of VaDAS-cog ( Vascular Dementia Assessment Scale cognitive subscale ) among time points [ Time Frame: 12 weeks, 24 weeks, 48 weeks ]
    Measure and record with VaDAS-cog


Secondary Outcome Measures :
  1. Measure and assess the changes of MMSE ( Mini-mental State Examination ) among time points [ Time Frame: 12 weeks, 24 weeks, 48 weeks ]
    Measure and record with MMSE

  2. Measure and assess the changes of ADL ( Activity of Daily Living ) among time points [ Time Frame: 12 weeks, 24 weeks, 48 weeks ]
    Measure and record with ADL

  3. Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points [ Time Frame: 12 weeks, 24 weeks, 48 weeks ]
    Measure and record with CDR

  4. Incidence rate of outcome event [ Time Frame: 24 weeks ]
    Record the outcome event and analyse the incidence rate

  5. Therapeutic effect [ Time Frame: 24 weeks ]
    Measure and record patients' systolic and diastolic blood pressure and analyse related data

  6. Metabonomics [ Time Frame: 24 weeks ]
    Measure and record the metabonomics ( Trx & TrxR ) index


Biospecimen Retention:   Samples With DNA
Blood sample; Urine sample.

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cognitive impairment caused by hypertension.
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。
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943420


Contacts
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Contact: Cheng Chang, PhD +8613851821996 chch1967@163.com

Locations
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China, Jiangsu
Jiangsu Province Hospital of Chinese Medcine Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Cheng Chang, PhD    +8613851821996    chch1967@163.com   
Sponsors and Collaborators
Jiangsu Famous Medical Technology Co., Ltd.
More Information
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Responsible Party: Jiangsu Famous Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03943420    
Other Study ID Numbers: BE2017770
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Famous Medical Technology Co., Ltd.:
Safety
Effectiveness
Therapy
 Qianyang Yuyin Granules
Cognitive impairment
Hypertension
Additional relevant MeSH terms:
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Hypertension
Cognitive Dysfunction
Vascular Diseases
Cardiovascular Diseases
 Cognition Disorders
Neurocognitive Disorders
Mental Disorders