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
1 other identifier
interventional
60
1 country
1
Brief Summary
The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedStudy Start
First participant enrolled
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedMarch 11, 2021
October 1, 2018
9 months
October 29, 2018
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Alpinia galanga
ACTIVE COMPARATOREnXtra: 2 capsules to be taken twice daily after breakfast and evening.
Composite (Alpinia galanga + Caffeine)
ACTIVE COMPARATORComposite: 2 capsules to be taken twice daily after breakfast and evening.
Placebo
PLACEBO COMPARATORMicrocellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vedic Lifesciences Pvt. Ltd
Mumbai, Opp Infinity Mall, 400053, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2018
First Posted
November 6, 2018
Study Start
November 23, 2018
Primary Completion
August 30, 2019
Study Completion
December 30, 2019
Last Updated
March 11, 2021
Record last verified: 2018-10