NCT04958512

Brief Summary

In this study, the effectiveness of vascular cognitive impairment was compared among the three groups, namely, the xidezhen group, the Yangxue Qingnao pill group and the placebo group

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

June 27, 2021

Last Update Submit

July 8, 2021

Conditions

Cerebrovascular Diseases

Keywords

cognitive disorder

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment Scale (MoCA)

    Level of cognition,ranging from 0-30 points, the higher score means better outcome

    at 6th month

Study Arms (3)

blank control group

OTHER
Other: blank control group

treatment group(Yangxue Qingnao pill)

EXPERIMENTAL
Drug: Yangxue Qingnao pill

control group(hidezhen)

ACTIVE COMPARATOR
Drug: Hydergotoxine mesylate tablets

Interventions

Yangxue Qingnao pillDRUG

The treatment group (20 cases) was treated with Yangxue Qingnao pill (2.5g / time, 3 times / day, orally for 6 months

treatment group(Yangxue Qingnao pill)
Hydergotoxine mesylate tabletsDRUG

The control group (n = 20) was treated with hidezhen 3 mg per day before meals for 6 months

control group(hidezhen)
blank control groupOTHER

There were 20 cases in the blank control group.Outpatient consultation at any time was prescribed.

blank control group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 50 years old, under 85 years old, male and female, including 50 and 85 years old;
  • The patients agreed to participate in the trial and signed the informed consent.
  • The diagnostic criteria for vascular cognitive impairment without dementia are as follows:
  • There are risk factors of cerebrovascular disease or the existence of cerebrovascular disease;
  • The development of cognitive impairment was fluctuating;
  • Mild memory impairment or retention;
  • There is a causal relationship between cerebrovascular disease and cognitive impairment, and other diseases are excluded;
  • The activities of daily living remained normal;
  • According to the diagnostic criteria of mild cognitive impairment (MCI) developed by Xiao Shifu, the subjects' MMSE score was less than or equal to 26

You may not qualify if:

  • The researchers considered that it was not suitable to be included in the study;
  • Known liver diseases of clinical significance, which may hinder patients from completing the test, and / or total bilirubin, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase are 1.5 times higher than the upper limit of normal value;
  • The patients with known clinically significant kidney disease may be prevented from completing the test, and / or the serum creatinine is higher than the normal range in the laboratory, and / or the blood urea nitrogen is 1.5 times higher than the normal range;
  • He had a history of acute cerebrovascular disease within 3 months;
  • At present, there is active epilepsy;
  • History of mental illness;
  • Peptic ulcer and gastrointestinal bleeding;
  • Any of the tested drugs was taken within 28 days before medication, which may cause cognitive changes and important organ damage.
  • Accompanied by unstable blood system and immune system diseases, is not in clinical remission.
  • Malignant tumor or intracranial tumor is known;
  • Those who had surgery within three months or had a history of trauma.
  • There are other advanced, serious or unstable diseases, which affect the evaluation of its efficacy and safety;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100098, China

Location

MeSH Terms

Conditions

Cerebrovascular DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Dongsheng Fan

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 12, 2021

Study Start

August 30, 2017

Primary Completion

January 31, 2018

Study Completion

March 31, 2018

Last Updated

July 12, 2021

Record last verified: 2021-06

Locations

CN(1)