An open label, single-arm, multicentre study to evaluate safety and efficacy of Nutricharge Energy Drink in healthy human volunteers in India
- Registration Number
- CTRI/2016/12/007593
- Lead Sponsor
- Trophic Wellness Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
a) Age group: 18 years - 40 years
b) Subjects in good physical condition and sound mental status.
c) In the judgment of the Principal Investigator, able to comply with protocol requirements.
d) Subjects passing all the screening tests
e) Subjects willing to sign written informed consent
a) Pre Diabetic & Diabetic Subjects
b) Pre-hypertensive & Hypertensive subjects
c) Subjects addicted to alcohol, Drugs of Abuse or tobacco
d) Hypersensitivity to study product or any contents of the energy drink
e) Presence of any major illness such as cancer, heart disease, COPD, Asthma etc.
f) Subjects with current medical history of any major illness such as cancer, heart disease, COPD , Asthma etc. in the past
g) Subjects with history of any acute or chronic illness that may affect the patientâ??s participation in the study
h) Current use of vitamin or mineral supplements, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
i) Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
j) Subjects with acute illness or history of major or minor surgery in the past one year.
k) Female subjects who are currently pregnant and/or breast feeding
l) Subjects receiving any medical therapy for any illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures: Safety <br/ ><br>Timepoint: Day 0 to Day 10 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary outcome measures: EfficacyTimepoint: Day 0 to Day 10