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OpenTrials
Completed

NCT Number: NCT03216681

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vietnam Military Medical University

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hoat Huyet Nhat Nhat

Drug

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

Tanakan 40mg

Drug

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

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

    Time frame: 45 days

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. The number of participants with clinically significant vital sign parameters at Day 45.

    Time frame: 45 days

  8. The number of participants with clinically significant laboratory parameters at Day 45.

    Time frame: 45 days

Sponsors and collaborators

Lead sponsor

Nhat Nhat Pharmaceutical Company

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2017
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.