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

Not Applicable

Completed

• Conditions: Caffeine Dependence
• Interventions: Dietary Supplement: Alpinia Galanga; Dietary Supplement: Microcellulose crystalline

• Registration Number: NCT03731286
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-06
• Study Start: 2018-11-23
• Primary Completion: 2019-08-30
• Study Completion: 2019-12-30
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alpinia galanga	Alpinia Galanga	EnXtra: 2 capsules to be taken twice daily after breakfast and evening.
Composite (Alpinia galanga + Caffeine)	Alpinia Galanga	Composite: 2 capsules to be taken twice daily after breakfast and evening.
Placebo	Microcellulose crystalline	Microcellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vedic Lifesciences Pvt. Ltd; 🇮🇳 Mumbai, Opp Infinity Mall, India