Health Condition 1: F439- Reaction to severe stress, unspecified
Conditions
Interventions
None listed
Sponsors
Olive Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: A) Participant is willing and able to give informed consent for participation in the trial, especially with diagnosed of stroke induced cognitive malfunction and Parkinsonââ?¬•s disease induced cognitive malfunction. B) Male or Female, aged 18 years or above. C) Diagnosed with required disease/severity/symptoms, any specific assessment criteria for these, or, if healthy volunteer trial: be in good health. D) Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter. E) Participant has clinically acceptable laboratory and ECG results (specify any other additional assessments) within of enrolment. F) In the Investigatorââ?¬•s opinion, is able and willing to comply with all trial requirements. G) Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Exclusion criteria
Exclusion criteria: A) Female participant who is pregnant, lactating or planning pregnancy during the trial. B) Significant renal or hepatic impairment. C) Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. D) Participant with life expectancy of less than 6 months or is inappropriate for placebo medication. E) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantââ?¬•s ability to participate in the trial. F) Participants who have participated in another research trial involving an investigational product in the past 12 weeks. G) Diagnosis of intellectual disability, dementia, or neurological disorder including but not limited to cerebral vascular disease; previous head injury, or coronary artery bypass or neurosurgical procedure; history of smoking, alcohol or drug abuse; metabolic disease including diabetes; untreated asthma; shift workers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study, we are intended to measure the effects of supplementing Lutein and Zeaxanthin with a range of baseline cognitive abilities as primary end pointTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut health, Mood Swing if anyTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactShanta Kumar
Olive Life Sciences Pvt Ltd
Outcome results
None listed