A Randomized Double Blind Placebo Controlled Parallel Group Study to Investigate the Effect of Biokesum on Cognition Sleep Quality and Mood in Subjects having Mild Cognitive Impairment - NI

Biotropics Malaysia Berhad0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1 Adults male and female aged between 50 to 75 years
•2 Adults with mild cognitive impairment MCI based on Peterson criteria
•3 Profile of mood state POMS score greater than 15 at the randomization or baseline day -1 visit 2
•4 BMI between 20 to 29 kg m2
•5 No plan to commence new treatment over the study period
•6 Adults must have complete secondary school education
•7 Must have the ability and willingness to sign an informed consent and comply with all study procedures

•1 Adults with the history of alcohol tobacco dependence or any substance abuse
•2 Pregnant and lactating women or suspected to be pregnant
•3 Adults with any neurodegenerative diseases (that is Parkinsons disease dementia)
•4 Adults who have been diagnosed with depressive disorder schizophrenia or score greater than 5 in Geriatric Depression Scale (GDS)
•5 The patient may be excluded from the study at the PIs discretion if any significant abnormalities are found during the laboratory assessment on visit 1 (Screening day -3 to 0)
•6 Adults with Attention Deficit Hyperactivity Disorder (ADHD) as this condition might interfere with cognitive function and psychosocial status
•7 Adults who regularly consume traditional herbs vitamins and minerals supplementation for the past 6 months because it will jeopardize the effect of the supplement used in the study
•8 Adults who has participated in other clinical trials during the previous 3 months
•9 Adults who have any clinical condition according to the investigator who does not allow safe fulfilment of clinical trial protocol

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