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

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

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

Study Overview

• Status: Completed
• Conditions: Insufficient Blood Supply to the Brain
• Intervention / Treatment: Drug: Hoat Huyet Nhat Nhat; Drug: Tanakan 40mg

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Vietnam Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with symptoms related to the insufficient blood supply to the brain.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hoat Huyet Nhat Nhat; Administered orally twice a day, 2 tablets each time, for 45 days.	Drug: Hoat Huyet Nhat Nhat; Administered orally twice a day, 2 tablets each time, for 45 days.
Tanakan 40mg; Administered orally three times a day, one tablet each time, for 45 days.	Drug: Tanakan 40mg; Administered orally three times a day, 1 tablet each time, for 45 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nhat Nhat Pharmaceutical Company

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 20, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HHNN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No