Conectar
B-vitamins and herbal supplements such as Passiflora incarnata have demonstrated potential benefits for cognitive and neurological functions. This study aims to evaluate the neural and biochemical effects of high-dose vitamin B multivitamin supplementation, with and without P. incarnata, in healthy adults using multimodal neuroimaging and biomarker assessments.
This is a phase I/II, randomised, double-blind, placebo-controlled clinical trial involving 108 healthy adults aged 30–55 years, allocated to three groups: (A) high-dose vitamin B multivitamin supplementation with P. incarnata; (B) high-dose vitamin B multivitamin supplementation alone; and (C) placebo. Participants will take two tablets daily for 24 weeks. The primary outcomes are changes in default mode network connectivity assessed using resting-state functional magnetic resonance imaging and diffusion magnetic resonance imaging, together with safety outcomes including vital signs, clinical laboratory parameters and adverse event monitoring. Secondary outcomes include regional brain metabolite concentrations measured by proton magnetic resonance spectroscopy and plasma biomarkers of one-carbon metabolism, including vitamin B6, vitamin B12, folate and homocysteine.
Ethics approval was granted by the Medical Research Ethics Committee, Ministry of Health Malaysia (NMRR-19-379-46101 (ISR); Protocol Number: Exec B). Results will be disseminated through peer-reviewed publications and scientific conferences.
ACTRN12622001150730.
Patient and Observer Scar Assessment Scale Version 3.0 (POSAS 3.0) is a robust instrument for scar evaluation. Currently, no validated POSAS 3.0 in the Malay language is available. This study aimed to translate, culturally adapt, and psychometrically evaluate POSAS 3.0 for Malay-speaking populations in Malaysia. Malaysian patients were recruited between 31 October 2023, to 31 December 2024. Translation was conducted using a forward and backward translation approach. Reliability was assessed using internal consistency (Cronbach's alpha) and test–retest. Face validity was addressed with 10 patients, and content validity was evaluated by four clinical specialists. Content validity was evaluated using the item-content validity index (I-CVI) and content validity ratio (CVR). Construct validity was assessed using exploratory factor analysis (EFA). Seventy-eight participants with facial (n = 39, 50.0%) and non-facial (n = 39, 50.0%) soft tissue scars were recruited for the EFA. The Malay POSAS-O demonstrated acceptable internal consistency (α = 0.75) and excellent inter-rater reliability, with item-level intraclass correlation coefficient (ICCs) ranging from 0.91 to 1.00 and total score ICC of 0.99. Agreement for categorical scar severity ratings was almost perfect (κ = 0.89). The Malay POSAS-P showed excellent internal consistency (α = 0.89), and test–retest reliability for the total score was good to excellent (ICC = 0.89). Intermittent symptom items (painful, shooting, burning and fragile) exhibited lower stability, reflecting natural symptom variability. Content validity was excellent, with all items achieving I-CVI and CVR values of 1.00. EFA supported construct validity, with adequate Kaiser-Meyer-Olkin (KMO) values (POSAS-O: 0.88; POSAS-P: 0.85), significant Bartlett's tests, strong communalities and factor loadings. The cumulative variance explained was 79.05% for POSAS-O and 68.19% for POSAS-P. The Malay version of the POSAS 3.0 is a reliable, valid, and culturally appropriate instrument for scar assessment. Its strong psychometric properties support its application in clinical practice and research involving Malay-speaking populations.
FreshRSS 