Hoat Huyet Nhat Nhat Versus Tanakan for Treatment of Symptoms Related to the Insufficient Blood Supply to the Brain

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Insufficient Blood Supply to the Brain

Intervention / Treatment
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* Drug: Hoat Huyet Nhat Nhat
* Drug: Tanakan 40mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hoat Huyet Nhat Nhat<br>Administered orally twice a day, 2 tablets each time, for 45 days. | Drug: Hoat Huyet Nhat Nhat<br>* Administered orally twice a day, 2 tablets each time, for 45 days.<br>|
| Tanakan 40mg<br>Administered orally three times a day, one tablet each time, for 45 days. | Drug: Tanakan 40mg<br>* Administered orally three times a day, 1 tablet each time, for 45 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |  | 45 days | 
| The number of participants with clinically significant vital sign parameters at Day 45. |  | 45 days | 
| The number of participants with clinically significant laboratory parameters at Day 45. |  | 45 days |