NCT02931747

Brief Summary

The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and cognitive processing in student.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2016

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

October 8, 2016

Last Update Submit

August 15, 2017

Conditions

Healthy

Keywords

Bacopa MonnieriWorking memoryCognitive processingStudent

Outcome Measures

Primary Outcomes (4)

  • Cognitive processing using the latency of P300 wave

    The latency of P300 wave was measured and expressed as millisecond.

    4 months

  • Cognitive processing using the amplitude of P300 wave

    The amplitude of P300 wave was measured and expressed as micro-volt.

    4 months

  • Attention using the latency of N100 wave

    The latency of N100 wave was measured and expressed as millisecond.

    4 months

  • Attention using the amplitude of N100 wave

    The amplitude of N100 wave was measured and expressed as micro-volt.

    4 months

Secondary Outcomes (16)

  • Accuracy of working memory using computerized battery test

    4 months

  • Speed of working memory using computerized battery test

    4 months

  • Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90)

    4 months

  • Assessment of mood scale using Bond-Lader visual analogue scales

    4 months

  • Acetylcholinesterase activity in serum

    4 months

  • +11 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects are received the pill of placebo which has same color, shape and smell like the Bacopa Monnieri once daily for 16 weeks.

Dietary Supplement: Placebo

Bacopa Monnieri 300 mg/day

ACTIVE COMPARATOR

Subjects are received the pill of Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks

Dietary Supplement: Bacopa Monnieri 300 mg/day

Bacopa Monnieri 600 mg/day

ACTIVE COMPARATOR

Subjects are received the pill of Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks

Dietary Supplement: Bacopa Monnieri 600 mg/day

Interventions

PlaceboDIETARY_SUPPLEMENT

Subjects are received Placebo once daily for 16 weeks.

Placebo
Bacopa Monnieri 300 mg/dayDIETARY_SUPPLEMENT

Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.

Bacopa Monnieri 300 mg/day
Bacopa Monnieri 600 mg/dayDIETARY_SUPPLEMENT

Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.

Bacopa Monnieri 600 mg/day

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy student subject aged between 15-18 years old who studying in the school within Khon Kaen province.
  • Body mass index is between 18.5-24.9

You may not qualify if:

  • Subjects who are diagnosed with one of the following: cardiovascular diseases, respiratory disease, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
  • Subjects who take any medicine or nutraceuticals or hormone that effect on central nervous system are excluded.
  • Alcohol addict or smoking addiction (more than 10 pieces/day)
  • Athlete or subjects who have a regular exercise more than 3 times/week
  • Subjects who don't follow the instruction during the trial
  • Subjects who are participating the other project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jitanaporn Wattanathorn

Khon Kaen, 40002, Thailand

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor Doctor

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 13, 2016

Study Start

July 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)