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

NCT ID: NCT03731286

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-23

Study Completion Date

2019-12-30

Brief Summary

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

Detailed Description

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Conditions

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Caffeine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alpinia galanga

EnXtra: 2 capsules to be taken twice daily after breakfast and evening.

Group Type ACTIVE_COMPARATOR

Alpinia Galanga

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Composite (Alpinia galanga + Caffeine)

Composite: 2 capsules to be taken twice daily after breakfast and evening.

Group Type ACTIVE_COMPARATOR

Alpinia Galanga

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Placebo

Microcellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening.

Group Type PLACEBO_COMPARATOR

Microcellulose crystalline

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Interventions

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Alpinia Galanga

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Alpinia Galanga

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Microcellulose crystalline

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Caffeine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vedic Lifesciences Pvt. Ltd

Mumbai, Opp Infinity Mall, India

Site Status

Countries

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India

Other Identifiers

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EB/180401/ENXTRA/EVRG

Identifier Type: -

Identifier Source: org_study_id

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