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

Caffeine Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731286
• Other study ID #: EB/180401/ENXTRA/EVRG
• Status: Completed
• Phase: N/A
• Start date: November 23, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2018
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caffeine Dependence

Intervention

Dietary Supplement:
• Alpinia Galanga
2 capsules
• Alpinia Galanga
2 capsules
• Microcellulose crystalline
2 capsules

Locations

Country	Name	City	State
India	Vedic Lifesciences Pvt. Ltd	Mumbai	Opp Infinity Mall

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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