Clinical study to evaluate the effect of herbal product Biokesum on cognition sleep quality and mood in subjects having mild cognitive impairment
- Conditions
- Health Condition 1: F318- Other bipolar disorders
- Registration Number
- CTRI/2024/07/070295
- Lead Sponsor
- Biotropics Malaysia Berhad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in visual memory verbal memory executive function symbol digit coding finger tapping Stroop shifting attention continuous performance <br/ ><br>short-term memory and Continuous Performance Test- IITimepoint: Baseline, week 8 & week 12
- Secondary Outcome Measures
Name Time Method Mean change in scores for the Profile of Mood States questionnaire <br/ ><br>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 <br/ ><br>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