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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03216681
• Date of registration: 09/07/2017
• Prospective Registration: No
• Primary sponsor: Nhat Nhat Pharmaceutical Company
• Public title: Hoat Huyet Nhat Nhat Versus Tanakan for Treatment of Symptoms Related to the Insufficient Blood Supply to the Brain
• Scientific 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
• Date of first enrolment: July 1, 2017
• Target sample size: 750
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03216681
• Study type: Observational

Countries of recruitment

Vietnam

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Insufficient Blood Supply to the Brain

Intervention(s)

Drug: Tanakan 40mg

Drug: Hoat Huyet Nhat Nhat

Primary Outcome(s)

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 [Time Frame: 45 days]

Secondary Outcome(s)

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 [Time Frame: 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) [Time Frame: 45 days]

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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 45 days]

The number of participants with clinically significant laboratory parameters at Day 45. [Time Frame: 45 days]

The number of participants with clinically significant vital sign parameters at Day 45. [Time Frame: 45 days]

Secondary ID(s)

HHNN-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors