Condition or disease |
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Hypertension |
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] |
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 |
Group/Cohort |
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Experimental Group
Therapy A : Basic treatment + Qianyang Yuyin Granules
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Negative Control Group
Therapy B : Basic treatment
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Positive Control Group
Therapy C : Basic treatment + Donepezil
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cheng Chang, PhD | +8613851821996 | chch1967@163.com |
China, Jiangsu | |
Jiangsu Province Hospital of Chinese Medcine | Recruiting |
Nanjing, Jiangsu, China, 210000 | |
Contact: Cheng Chang, PhD +8613851821996 chch1967@163.com |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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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. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | 4 Weeks | ||||
Biospecimen | Retention: Samples With DNA Description:
Blood sample; Urine sample.
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Sampling Method | Probability Sample | ||||
Study Population | Patients with cognitive impairment caused by hypertension. | ||||
Condition | Hypertension | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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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 |