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

Priya H. Soni; Mandip Goyal

doi:10.18203/2349-3259.ijct20253338

Authors

Priya H. Soni Department of Kayachikitsa, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India
Mandip Goyal Department of Kayachikitsa, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20253338

Keywords:

Guduchyadi ghrita, Mild neurocognitive disorder, Brain-derived neurotrophic factor, Pratimarsha nasya

Abstract

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).

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References

American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Arlington (VA): American Psychiatric Publishing; 2013. Available at: https://psychiatryonline.org/ doi/book/10.1176/appi.books.9780890425596 Accessed on 18 November 2022. DOI: https://doi.org/10.1176/appi.books.9780890425787

Available at: https://www.researchgate.net/ publication/276356624_An_Abbreviated_Montreal_Cognitive_Assessment_MoCA_for_Dementia_Screening. Accessed on 11 November 2024.

Available at: https://researcher.manipal.edu/en/ publications/validity-and-reliability-of-montreal-cognitive-assessment-and-its. Accessed on 11 November 2024.

Available at: https://sites.cscc.unc.edu/cscc/. Accessed on 11 November 2024.

Bucks RS, Ashworth DL, Wilcock GK, Siegfried K. Bristol activities of daily living scale. Available at: https://www.physio-pedia.com/images/1/1f/Bristal_ ADL_scale.pdf. Accessed on 14 November 2024.

Quality of Life in Alzheimer’s Disease. Available at: https://www.cogsclub.org.uk/professionals/files/ QOL-AD.pdf Accessed on 18 November 2022.

Liu-Ambrose T, Falck RS, Dao E, Best JR, Davis JC, Bennett K, et al. Effect of exercise training or complex mental and social activities on cognitive function in adults with chronic stroke: a randomized clinical trial. JAMA Net Open. 2022;5(10):e2236510. DOI: https://doi.org/10.1001/jamanetworkopen.2022.36510

Knight Alzheimer Disease Research Center. Available at: https://knightadrc.wustl.edu/ professionals-clinicians/ad8-instrument/ Accessed on 18 November 2022.

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Section II, Fifth Edition. Arlington, VA: American Psychiatric Association; 2013:605. Available at: https://www.psychiatry.org/psychiatrists/practice/dsm Accessed on 18 November 2022.

Chaudhuri K, Samarakoon SM, Chandola HM, Rajesh K, Ravishankar B. Clinical Evaluation of Medhyarasayana Ghrita along with Vachadi Ghrita Nasya (Pratimarsha) on Senile Dementia. 2019.