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

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ClinicalTrials.gov Identifier: NCT03216681
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Nhat Nhat Pharmaceutical Company

Brief Summary:
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 or disease Intervention/treatment
Insufficient Blood Supply to the Brain Drug: Hoat Huyet Nhat Nhat Drug: Tanakan 40mg

Study Type : Observational
Actual Enrollment : 750 participants
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
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 30, 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
Vietnam
Vietnam Military Medical University
Hanoi, Vietnam
Sponsors and Collaborators
Nhat Nhat Pharmaceutical Company

Responsible Party: Nhat Nhat Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT03216681     History of Changes
Other Study ID Numbers: HHNN-01
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: October 23, 2018
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