Health Condition 1: - Health Condition 2: null- Fatigue condition
Conditions
Interventions
Intervention1: Instavit® Instant energy 14ml/0.5 Fl OZ
: Oral energy Supplement with Caffeine and Vit B12
Spray 1-4 times into your mouth or under your tongue For 28 days
Control Intervention1: Place
Sponsors
Instavit Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Mentally, physically and legally eligible to give informed consent. 2. Male and female BMI between 20.0 â?? 25.9 kg/m2 3. Subject meet criteria for fatigue as per Chalder Fatigue Assessment scale. 4. Subjects willing and able to provide informed consent voluntarily 5. Patient is willing and able to comply with all trial requirements
Exclusion criteria
Exclusion criteria: 1. Significant medical or psychiatric illness 2. Subjects having history of drug or alcohol abuse 3. Previous receipt of Study Drug 4. History of HIV, HAV, HBs Ag 5. Volunteers who have participated in any drug research study within past 3 months. 6. Presence or history of hypersensitivity to any of the active or inactive ingredients 7. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in fatigue level by using Fatigue assessment test 2. Changes in severity of fatigue by using Fatigue Severity scale 3. Improvement in overall condition by assessing the Changes in Piper fatigue scale from baseline to EOT Timepoint: from baseline to End Of Treatment(28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of energy level by using Ergometer for instant energy. 2. Changes in Chalder Fatigue Assessment scale. 3. Incidence and Rate of adverse events. Timepoint: from baseline to End Of Treatment (28 days) | — |
Countries
India
Contacts
Public ContactDr Harisha s
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed