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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03731286

Enrollment

Registered

2018-11-06

Start date

2018-11-23

Completion date

2019-12-30

Last updated

2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caffeine Dependence

Brief summary

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

Interventions

DIETARY_SUPPLEMENTAlpinia Galanga

2 capsules

DIETARY_SUPPLEMENTMicrocellulose crystalline

2 capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026