A Clinical study to compare the Efficacy & Safety of Instavit instant energy oral spray for the fatigue conditio
Not Applicable
Completed
- Conditions
- Health Condition 1: - Health Condition 2: null- Fatigue condition
- Registration Number
- CTRI/2018/01/011170
- Lead Sponsor
- Instavit Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Improvement in fatigue level by using Fatigue assessment test <br/ ><br>2. Changes in severity of fatigue by using Fatigue Severity scale <br/ ><br>3. Improvement in overall condition by assessing the Changes in Piper fatigue scale from baseline to EOT <br/ ><br>Timepoint: from baseline to End Of Treatment(28 days) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Assessment of energy level by using Ergometer for instant energy. <br/ ><br>2. Changes in Chalder Fatigue Assessment scale. <br/ ><br>3. Incidence and Rate of adverse events. <br/ ><br>Timepoint: from baseline to End Of Treatment (28 days) <br/ ><br>