Insufficient Blood Supply to the Brain Clinical Trial
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
| NCT number | NCT03216681 |
| Other study ID # | HHNN-01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2017 |
| Est. completion date | April 30, 2018 |
| Verified date | July 2017 |
| Source | Nhat Nhat Pharmaceutical Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | April 30, 2018 |
| Est. primary completion date | April 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Vietnam | Vietnam Military Medical University | Hanoi |
| Lead Sponsor | Collaborator |
|---|---|
| Nhat Nhat Pharmaceutical Company |
Vietnam,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | The number of participants with clinically significant vital sign parameters at Day 45. | 45 days | ||
| Secondary | The number of participants with clinically significant laboratory parameters at Day 45. | 45 days |