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

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

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

Study Overview

• Status: Completed
• Conditions: Caffeine Dependence
• Intervention / Treatment: Dietary supplement: Alpinia Galanga; Dietary supplement: Microcellulose crystalline

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Opp Infinity Mall
    • Mumbai, Opp Infinity Mall, India, 400053
      • Vedic Lifesciences Pvt. Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alpinia galanga; EnXtra: 2 capsules to be taken twice daily after breakfast and evening.	Dietary supplement: Alpinia Galanga; 2 capsules; Other Names: Caffeine
Active Comparator: Composite (Alpinia galanga + Caffeine); Composite: 2 capsules to be taken twice daily after breakfast and evening.	Dietary supplement: Alpinia Galanga; 2 capsules; Other Names: Caffeine
Placebo Comparator: Placebo; Microcellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening.	Dietary supplement: Microcellulose crystalline; 2 capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ECG from baseline to end of the treatment.	ECG parameters including PR interval, QRS duration, QT interval and RR interval will be evaluated from baseline and end of the treatment	84 Days

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2018
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: EB/180401/ENXTRA/EVRG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No