Publication:

A study protocol for assessing the efficacy of Guduchyadi Ghrita in mild neurocognitive disorder: a placebo-controlled trial with brain-derived neurotrophic factor evaluation

Background Mild neurocognitive disorder (mNCD), a preclinical stage of dementia, is becoming a significant public health concern, especially among the aging population. Brain-derived neurotrophic factor (BDNF) has emerged as a key biomarker for cognitive health. Guduchyadi Ghrita, an Ayurvedic formulation rich in nootropic, Rasayana, and antioxidant herbs, has shown promise in improving cognitive functions, including memory and attention, in preliminary studies. Pratimarsha Nasya, known for its brain-targeted therapeutic effects, may enhance the bioavailability of these compounds. This study aims to evaluate the efficacy of Guduchyadi Ghrita with Pratimarsha Nasya in improving cognition and BDNF levels in individuals with mNCD.

Methods This randomized, placebo-controlled, open-label, single-centre clinical trial will involve 80 participants diagnosed with mNCD according to DSM-V criteria. Group A will receive 12 gm/day of Guduchyadi Ghrita orally and 2 drops per nostril of Pratimarsha Nasya for 60 days, following Deepana-Pachana and Mridu Virechana. Group B will receive a placebo (roasted semolina capsules) and cognitive stimulation activities for 60 days. Primary outcomes will include improvements in cognition, assessed using the Montreal cognitive assessment (MoCA). Secondary outcomes will involve changes in plasma BDNF levels, quality of life (QOL-AD), and daily functioning (Bristol ADL scale).

Conclusions This study will assess the potential of Guduchyadi Ghrita and Pratimarsha Nasya in enhancing cognitive function and promoting neuroplasticity in individuals with mNCD, with a focus on BDNF as a biomarker. Trial registration: The trial is registered with the Clinical Trials Registry of India (CTRI) (REF/2025/04104935).