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The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpinia galanga | Active Comparator | EnXtra: 2 capsules to be taken twice daily after breakfast and evening. |
|
| Composite (Alpinia galanga + Caffeine) | Active Comparator | Composite: 2 capsules to be taken twice daily after breakfast and evening. |
|
| Placebo | Placebo Comparator | Microcellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpinia Galanga | Dietary Supplement | 2 capsules |
| |
| Alpinia Galanga |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vedic Lifesciences Pvt. Ltd | Mumbai | Opp Infinity Mall | 400053 | India |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Dietary Supplement |
2 capsules |
|
|
| Microcellulose crystalline | Dietary Supplement | 2 capsules |
|
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |