An open label, single-arm, multicentre study to evaluate safety and efficacy of Nutricharge Energy Drink in healthy human volunteers in India

Phase 3

Brief Summary: This is an open label, single arm, multicenter clinical study to evaluate efficacy and safety of NutrichargeÃ¢ Energy Drink in healthy subjects. A total of up to 115 healthy adults will be enrolled to get 100 completed subjects in to the study. The study is a multi-center study with up to 3 sites participating in the study. Test Product: NutrichargeÃ¢ Energy Drink, Trophic Wellness Pvt. Ltd. Test product is required to be consumed orally after lunch between 3â€“3.30 pm once daily for 10 days.Pack Size: 200 ml â€“ Tetra pack (1 Pack a day)

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Primary outcome measures: Safety	Day 0 to Day 10

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures: Efficacy	Day 0 to Day 10

Locations (2): Het Medical Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Prisha Medical Care
🇮🇳
Ahmadabad, GUJARAT, India
Het Medical Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Jignesh Shah
Principal investigator
9904333669
drjignesh81@gmail.com