NCT03216681

Brief Summary

The purpose of this study is to evaluate the effectiveness of Hoat Huyet Nhat Nhat on the reduction of common symptoms related to the insufficient blood supply to the brain such as headache, vertigo, dizziness, sleep disorders and forgetfulness; compared with Gingko Biloba Egb761 (Tanakan) after 45 days of treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

October 23, 2018

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

July 9, 2017

Last Update Submit

October 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with symptoms related to the insufficient blood supply to the brain recovered after 45 days of treatment as assessed by Symptom Improvement Likert Scale in Hoat Huyet Nhat Nhat and Tanakan 40mg group

    45 days

Secondary Outcomes (8)

  • Change From Baseline to 45 days of the severity of headache symptom in patients with symptoms related to the insufficient blood supply to the brain as assessed by Visual Analog Scale (VAS)

    45 days

  • Change From Baseline to 45 days of the severity of vertigo symptom in patients with symptoms related to the insufficient blood supply to the brain as assessed by Visual Analog Scale (VAS)

    45 days

  • Change From Baseline to 45 days of the severity of dizziness symptom in patients with symptoms related to the insufficient blood supply to the brain as assessed by Visual Analog Scale (VAS)

    45 days

  • Change From Baseline to 45 days of the severity of sleep disorders symptom in patients with symptoms related to the insufficient blood supply to the brain as assessed by Visual Analog Scale (VAS)

    45 days

  • Change From Baseline to 45 days of the severity of forgetfulness symptom in patients with symptoms related to the insufficient blood supply to the brain as assessed by Visual Analog Scale (VAS)

    45 days

  • +3 more secondary outcomes

Study Arms (2)

Hoat Huyet Nhat Nhat

Administered orally twice a day, 2 tablets each time, for 45 days.

Drug: Hoat Huyet Nhat Nhat

Tanakan 40mg

Administered orally three times a day, one tablet each time, for 45 days.

Drug: Tanakan 40mg

Interventions

Administered orally twice a day, 2 tablets each time, for 45 days.

Hoat Huyet Nhat Nhat

Administered orally three times a day, 1 tablet each time, for 45 days.

Tanakan 40mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients with symptoms related to the insufficient blood supply to the brain.

You may qualify if:

  • Male and Female more than 18 year old.
  • With at least one of the symptoms related to the insufficient blood supply to the brain scored more than 5 out 10, on the Visual Analog Scale.
  • Patients who will be using either Hoat Huyet Nhat Nhat or Tanakan following doctor's prescription or by patients own decision.
  • Sign the informed consent form

You may not qualify if:

  • Use of any medications for treatment of the insufficient blood supply to the brain in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnam Military Medical University

Hanoi, Vietnam

Location

MeSH Terms

Interventions

Ginkgo biloba extract

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 13, 2017

Study Start

July 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 30, 2018

Last Updated

October 23, 2018

Record last verified: 2017-07

Locations