CompletedNot Applicable

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

India60 participantsStarted 2018-11-23

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. History of regular caffeine consumption.
✓. Body mass index (BMI) of ≥18.5 and \<25.00 kg/m2.
✓. Fasting blood glucose \< 126 mg/dl
✓. Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
✓. Participants who are willing to abstain from use of any nutritional supplement and herbal preparation 48 hrs prior to study visit.

✕. Participants unable to abstain from caffeine-containing products for 12 hours prior to the site visit.
✕. Known cases of type II Diabetes Mellitus.
✕. Participants with uncontrolled hypertension (≥140/90 mm Hg), with or without anti-hypertensive medication.
✕. Participants suffering from primary or secondary insomnia with/ without active treatment.

Change in ECG from baseline to end of the treatment.

Timeframe: 84 Days

NCT IDNCT03731286

SponsorVedic Lifesciences Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-30