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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007593

Enrollment

115

Registered

2016-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nutricharge(R) Energy Drink: Subjects should consume the Nutricharge Energy drink orally after lunch between 3-3.30 p.m. daily for 10 days. [1 pack (200ml) in a day].

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary outcome measures: Safety Timepoint: Day 0 to Day 10	—

Secondary

Measure	Time frame
Secondary outcome measures: EfficacyTimepoint: Day 0 to Day 10	—

Countries

India

Contacts

Public ContactMr Arvind Sakhi

Trophic Wellness Private Limited

arvind@nutricharge.in022-28680353

Outcome results