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

This study is currently recruiting participants.
Verified July 2017 by Nhat Nhat Pharmaceutical Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT03216681
First Posted: July 13, 2017
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nhat Nhat Pharmaceutical Company
  Purpose
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

Condition Intervention
Insufficient Blood Supply to the Brain Drug: Hoat Huyet Nhat Nhat Drug: Tanakan 40mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Nhat Nhat Pharmaceutical Company:

Primary Outcome Measures:
  • 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 Measures:
  • 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 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 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 ]
  • 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 all symptoms related to the insufficient blood supply to the brain as assessed by Khadjev Score [ Time Frame: 45 days ]
  • The number of participants with clinically significant vital sign parameters at Day 45. [ Time Frame: 45 days ]
  • The number of participants with clinically significant laboratory parameters at Day 45. [ Time Frame: 45 days ]

Estimated Enrollment: 750
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: March 31, 2018
Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients with symptoms related to the insufficient blood supply to the brain.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216681


Contacts
Contact: Pham Ngoc Hung, PhD 84.989057989 pnhungqy@gmail.com
Contact: Tran Phuong 84.24.35 62 5766

Locations
Vietnam
Vietnam Military Medical University Recruiting
Hanoi, Vietnam
Contact: Pham Ngoc Hung, PhD.    84.989057989    pnhungqy@gmail.com   
Sponsors and Collaborators
Nhat Nhat Pharmaceutical Company
  More Information

Responsible Party: Nhat Nhat Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT03216681     History of Changes
Other Study ID Numbers: HHNN-01
First Submitted: July 9, 2017
First Posted: July 13, 2017
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No