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

Vedic Lifesciences

Status: Completed

Conditions: Caffeine Dependence

Treatments: Dietary Supplement: Microcellulose crystalline; Dietary Supplement: Alpinia Galanga

Study type: Interventional

Funder types: Industry

Identifiers

NCT03731286

EB/180401/ENXTRA/EVRG

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 3 patient groups, including a placebo group

Alpinia galanga

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Alpinia Galanga

Dietary Supplement: Alpinia Galanga

Composite (Alpinia galanga + Caffeine)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Alpinia Galanga

Dietary Supplement: Alpinia Galanga

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Microcellulose crystalline