Clinical trial NCT03216681: Hoat Huyet Nhat Nhat Versus Tanakan for Treatment of Symptoms Related to the Insufficient Blood Supply to the Brain
Official title: An Observational, Open Label, Post Marketing Study to Evaluate the Safety and Effectiveness of Hoat Huyet Nhat Nhat Compared With Gingko Biloba EGb761 (Tanakan 40mg) in Patients With Symptoms Related to the Insufficient Blood Supply to the Brain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insufficient Blood Supply to the Brain
Lead sponsor: Nhat Nhat Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2017-07-13
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients with symptoms related to the insufficient blood supply to the brain.

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: 45 days
Secondary outcomes:
measure: 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)
timeFrame: 45 days
measure: 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)
timeFrame: 45 days
measure: 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)
timeFrame: 45 days
measure: 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)
timeFrame: 45 days
measure: 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)
timeFrame: 45 days
measure: Change From Baseline to 45 days of the severity of all symptoms related to the insufficient blood supply to the brain as assessed by Khadjev Score
timeFrame: 45 days
measure: The number of participants with clinically significant vital sign parameters at Day 45.
timeFrame: 45 days
measure: The number of participants with clinically significant laboratory parameters at Day 45.
timeFrame: 45 days
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam Military Medical University
Study officials:
References: