Health Condition 1: F318- Other bipolar disorders
Conditions
Interventions
Intervention1: Biokesum Tablet: Participants will be given 350mg of tablet as per the randomization schedule to take orally for 84 days.
Control Intervention1: Placebo Tablet: Participants will be giv
Sponsors
Biotropics Malaysia Berhad
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in visual memory verbal memory executive function symbol digit coding finger tapping Stroop shifting attention continuous performance short-term memory and Continuous Performance Test- IITimepoint: Baseline, week 8 & week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in scores for the Profile of Mood States questionnaire Mean change in Pittsburgh Sleep Quality Index questionnaire scores, Brief Pain Inventory Short Form questionnaire scores, cognitive markers Brain Derived Neurotrophic Factor & acetyl cholinesterase, hsCRP, serum cortisol, plasma glutathione, Treatment Emergent Adverse Events Number & proportion of Treatment Emergent Serious Adverse Events, Liver parameters, Renal parameters, Complete Blood Count parameters, Lipid parameters & Urine parametersTimepoint: Baseline, week 8 & week 12 | — |
Countries
India
Contacts
Public ContactDr Mrutyunjaya Ganiger
Croissance Clinical Research Pvt Ltd
Outcome results
None listed