None listed
Conditions
Interventions
Intervention1: Caffeine granules: 5g, twice daily, oral , 15 days
Control Intervention1: Pharmacological Inert powder: 5g, twice daily, oral, 15 days
Sponsors
ITC Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects between the age groups of 18â??60 years 2.Subjects willing to participate and comply with the protocol procedures by signing an Informed Consent Form to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with the current history of smoking and/or alcohol consumption. 2.Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc. 3.Subjects with a known history of any malignant disease. 4.Subjects with known history of autoimmune disease and other systemic diseases related to immune system. 5.Subjects suffering with any severe infectious or communicable diseases like HIV & HBsAg. 6.Subjects with concomitant treatment with corticosteroids. 7.Subjects who participated in another clinical trial less than 3 months prior to this study. 8.Female subjects, who are pregnant, breast feeding or expecting pregnancy during the study period. 9.Subjects with the history of consumption of any recreational drugs. 10.Subjects who are scheduled for any surgery within 3 months period of completing the study. 11.Subjects who are pre-diabetic/ diabetic or hypertensive or hyperlipidemic 12.Subjects with inability or unwillingness to abide by the requirements of the protocol. 13.Subjects who are incompetent to sign an Informed Consent Form. 14.Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline to the end of the treatment period in: o Profile of Mood States (POMS) Scale Score. Timepoint: 0 Day, 7th Day, 15th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from the baseline to the end of the treatment period in: o WHO-Quality of Life (WHOQOL-BREF) o Laboratory Safety Parameters o Treatment Emergent Adverse events (AEs)-frequency and severityTimepoint: 0 Day, 15th Day | — |
Countries
India
Contacts
Public ContactDr Parag Vilas Naik
ITC Limited
Outcome results
None listed