Skip to main content
OpenTrials
Completed

NCT Number: NCT03731286

A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults

The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caffeine Dependence

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vedic Lifesciences Pvt. Ltd

Mumbai, Opp Infinity Mall, 400053, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of regular caffeine consumption.
  • Body mass index (BMI) of ≥18.5 and <25.00 kg/m2.
  • Fasting blood glucose < 126 mg/dl
  • Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
  • Participants who are willing to abstain from use of any nutritional supplement and herbal preparation 48 hrs prior to study visit.

Exclusion criteria

  • Participants unable to abstain from caffeine-containing products for 12 hours prior to the site visit.
  • Known cases of type II Diabetes Mellitus.
  • Participants with uncontrolled hypertension (≥140/90 mm Hg), with or without anti-hypertensive medication.
  • Participants suffering from primary or secondary insomnia with/ without active treatment.

Treatment and study plan

Alpinia Galanga

Dietary Supplement

2 capsules

Microcellulose crystalline

Dietary Supplement

2 capsules

Primary outcomes

  1. Change in ECG from baseline to end of the treatment.

    Time frame: 84 Days

    ECG parameters including PR interval, QRS duration, QT interval and RR interval will be evaluated from baseline and end of the treatment

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Registry information

Official study title

A Double-Blind Randomized, Double-dummy, Placebo-controlled, Parallel-Group Study of the Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2018
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.