| Condition or disease |
|---|
| 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 |
|---|
|
Experimental Group
Therapy A : Basic treatment + Qianyang Yuyin Granules
|
|
Negative Control Group
Therapy B : Basic treatment
|
|
Positive Control Group
Therapy C : Basic treatment + Donepezil
|
| 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 | |||||
|---|---|---|---|---|---|
| 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 |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
||||
| 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 |
|
||||
| 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:
|
||||
| Sex/Gender |
|
||||
| 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 | ||||