Caffeine DependenceNCT03731286
A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults
A study testing Alpinia Galanga and Microcellulose crystalline in people with Caffeine Dependence, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine Dependence
- What is being tested?
- Alpinia Galanga and Microcellulose crystalline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 23 Nov 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.
- Conditions
- Caffeine Dependence
- Being tested
- Alpinia Galanga, Microcellulose crystalline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpinia GalangaDietary supplement
2 capsules
Alpinia GalangaDietary supplement
Also called Caffeine
2 capsules
Microcellulose crystallineDietary supplement
2 capsules
| Study group | Role | What they receive |
|---|---|---|
| Alpinia galanga | Active comparator | EnXtra: 2 capsules to be taken twice daily after breakfast and evening. Receives: Dietary Supplement: Alpinia Galanga |
| Composite (Alpinia galanga + Caffeine) | Active comparator | Composite: 2 capsules to be taken twice daily after breakfast and evening. Receives: Dietary Supplement: Alpinia Galanga |
| Placebo | Placebo comparator | Microcellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening. Receives: Dietary Supplement: Microcellulose crystalline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start23 Nov 2018
- Primary completion30 Aug 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caffeine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731286
- Sponsor's protocol ID
- EB/180401/ENXTRA/EVRG
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03731286
- Acronym / sponsor ID
- EB/180401/ENXTRA/EVRG
- Conditions
- Caffeine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpinia galanga | Active comparator | Dietary Supplement: Alpinia GalangaEnXtra: 2 capsules to be taken twice daily after breakfast and evening. |
| Composite (Alpinia galanga + Caffeine) | Active comparator | Dietary Supplement: Alpinia GalangaComposite: 2 capsules to be taken twice daily after breakfast and evening. |
| Placebo | Placebo comparator | Dietary Supplement: Microcellulose crystallineMicrocellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpinia Galanga2 capsules | Dietary supplement | Alpinia galanga |
| Alpinia GalangaAlso: Caffeine2 capsules | Dietary supplement | Composite (Alpinia galanga + Caffeine) |
| Microcellulose crystalline2 capsules | Dietary supplement | Placebo |
Primary outcome
Change in ECG from baseline to end of the treatment.
Time frame: 84 Days
ECG parameters including PR interval, QRS duration, QT interval and RR interval will be evaluated from baseline and end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpinia Galanga and Microcellulose crystalline in people with Caffeine Dependence, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ECG from baseline to end of the treatment. (time frame: 84 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.