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A Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals

NCT06560008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-06-18

No results posted yet for this study

Summary

Acute Stage: The present study is a randomized, double-blind, placebo-controlled, single-dose, 4-way, cross-over, study. Approximately not more than 170 individuals will be screened and considering a screening failure rate of 25%, approximately 128 individuals will be randomized in a ratio of 1:1:1:1 to receive one of the IPs and will be assigned a unique randomization code. In this stage, approximately 114 individuals will complete the study, after accounting for a dropout/withdrawal rate of 15%. The intervention duration is 4 days \[1 (single dose) x 4 periods\].

Sub-Acute Stage: The present study is a randomized, double-blind, placebo-controlled, 4 arms, parallel study. In this stage, approximately 112 individuals will be re-randomized in a ratio of 1:1:1:1 to receive one of the IPs and will be assigned a unique randomization code. Each group will have not less than 24 completed participants after accounting for a dropout/withdrawal rate of 15%. The intervention duration is 28 days.

Conditions

Interventions

DIETARY_SUPPLEMENT

EnXtra® (300 mg) + Placebo (300 mg)

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

DIETARY_SUPPLEMENT

Caffeine (200 mg) + Placebo (300 mg)

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

DIETARY_SUPPLEMENT

EnXtra® (300 mg) + Caffeine (200 mg)

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

DIETARY_SUPPLEMENT

Placebo (MCC 300 mg) + Placebo (300 mg)

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

Sponsors & Collaborators

  • Enovate Biolife Pvt Ltd

    collaborator INDUSTRY

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2025-03-21
Completion
2025-03-21

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06560008 on ClinicalTrials.gov