4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / One Research on Improving Cognitive Impairment Caused by Hypertension

One Research on Improving Cognitive Impairment Caused by Hypertension

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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
Layout table for eligibility information
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

Contacts
Layout table for location contacts
Contact: Cheng Chang, PhD +8613851821996 chch1967@163.com

Locations
Layout table for location information
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.
Tracking Information
First Submitted Date January 29, 2019
First Posted Date May 9, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date December 28, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2019)
  • 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.
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 7, 2019)
  • 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
  • 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
  • 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
  • Incidence rate of outcome event [ Time Frame: 24 weeks ]
    Record the outcome event and analyse the incidence rate
  • Therapeutic effect [ Time Frame: 24 weeks ]
    Measure and record patients' systolic and diastolic blood pressure and analyse related data
  • Metabonomics [ Time Frame: 24 weeks ]
    Measure and record the metabonomics ( Trx & TrxR ) index
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title One Research on Improving Cognitive Impairment Caused by Hypertension
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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 4 Weeks
Biospecimen Retention:   Samples With DNA
Description:
Blood sample; Urine sample.
Sampling Method Probability Sample
Study Population Patients with cognitive impairment caused by hypertension.
Condition Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • Experimental Group
    Therapy A : Basic treatment + Qianyang Yuyin Granules
  • Negative Control Group
    Therapy B : Basic treatment
  • Positive Control Group
    Therapy C : Basic treatment + Donepezil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 7, 2019)
144
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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。
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03943420
Other Study ID Numbers BE2017770
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jiangsu Famous Medical Technology Co., Ltd.
Study Sponsor Jiangsu Famous Medical Technology Co., Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account Jiangsu Famous Medical Technology Co., Ltd.
Verification Date April 2019