Clincosm LogoSign in Get a demo

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

Sponsor
Vedic Lifesciences Pvt. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03731286
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
13.2
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Alpinia Galanga
  • Dietary Supplement: Alpinia Galanga
  • Dietary Supplement: Microcellulose crystalline
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official 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
Actual Study Start Date :
Nov 23, 2018
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

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
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

    Outcome Measures

    Primary Outcome Measures

    1. Change in ECG from baseline to end of the treatment. [84 Days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vedic Lifesciences Pvt. Ltd Mumbai Opp Infinity Mall India 400053

    Sponsors and Collaborators

    • Vedic Lifesciences Pvt. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vedic Lifesciences Pvt. Ltd.
    ClinicalTrials.gov Identifier:
    NCT03731286
    Other Study ID Numbers:
    • EB/180401/ENXTRA/EVRG
    First Posted:
    Nov 6, 2018
    Last Update Posted:
    Mar 11, 2021
    Last Verified:
    Oct 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Caffeine

    Study Results

    No Results Posted as of Mar 11, 2021