Banaras Hindu University, India
Title: Brahmi Ghrita: A potential drug for comprehensive treatment of Alzheimerâ€™s Disease
Richa Tripathi, M.D. (Ayurveda) is persuing her PhD in Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University (BHU), Varanasi, Uttar Pradesh, India. She earned MD degree in Panchakarma from Bharti Vidyapeeth University, Pune, Maharashtra in 2012. She served as assistant professor in Ayurved College, Shree Baba Mast Nath University, Asthal Bohar, Rohtak, Haryana from Aug 2012 to Feb 2014. She has served the society as an Ayurvedic physician and cancer counselor at D.S. Research Center, Varanasi, Uttarpradesh, India from feb 2014 to dec 2014. She actively campaigned for early diagnosis and cancer prevention in Varanasi and is a well-known face in local newspapers. She has done a lot of health campaign through All india Radio Pradeshik Seva for Cancer and Alzheimer’s Disease prevention. She has published many research papers in national and international journals like International Ayurvedic Medical Journal, World Journal of Pharmacy and Pharmaceutical Sciences, International Journal of Ayurveda and Pharmaceutical Chemistry, IJAAS, Medha International Interdisciplinary journal. She has presented numerous papers in national and International seminars. Her current research on Alzheimer’s Disease got noticed in Alzheimer’s Association International Conference, Chicago 2018.
Background: In the anticipation of disease modifying treatments for Alzheimer’s disease, Brahmi Ghrita, a polyherbal Ayurvedic medicine traditionally used for enhancing memory and cognition, was tested on 30 diagnosed patients of mild cognitive impairment (MCI) due to Alzheimer’s disease. Donepezil, a contemporary treatment, often results in vivid side-effects. The study was conducted to compare the effect of Brahmi Ghrita and Donepezil in MCI due to Alzheimer’s.
Objectives: The objective was to investigate the cognitive response of Brahmi Ghrita on Mild Cognitive Impairment due to AD. The trial was conducted on 30 diagnosed patients of MCI due to AD. The cases were compared with same number of patients undergoing allopathic treatment of MCI (Donepezil 10mg/day and the data was evaluated with respect to score changes in ADAS- Cog scale.
Materials and Methods: It was an open label, single centered, comparative, prospective, pragmatic trial. The trial protocol and related documents were reviewed and approved by the Institutional Ethical Committee, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P., India. The study was conducted in accordance with Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants. Trial had registered in the clinical trial registry of India (CTRI/2017/07/009171).Primary outcome measure of study was to evaluate efficacy of Ayurvedic formulation Brahmi Ghrita in the subjects suffering from Mild cognitive impairment due to Alzheimer’s Disease by assessing change in ADAS- cog scale and 3MS (Modified Mini Mental Examination Score) total Score. The secondary outcome measures was to evaluate the changes in inflammatory markers TNFa and IL10 in all the samples.
Total 84 patients (>40 years, either sex), with progressive decline in cognition (>6 months), a 3MS score of 79-100, without severe depressive disease were enrolled in the study. They were randomly divided into two groups - Donepezil group (DzG) and Brahmi Ghrita group (BGG). Donepezil’s dose of 5mg/day and Brahmi Ghrita’s dose of 12gm BD empty stomach were administered orally up to 12 weeks to both the groups, respectively. The efficacy of both the groups were assessed through the changes from baseline ADAS-Cog11 scores and were compared.
Results: 60 patients were part of the study. Out of which 30 patients were treated with Brahmi Ghrita and the rest 30 with Donepezil (5mg/day). Statistically significant change from baseline ADAS-Cog11 was observed for BG after 3 months. At week 12, 23 patients (76.6%) had stable and improved ADAS-Cog11. The group where ADAS BG (p value = 0.01) was administered showed significant impact on the patients. Also, the group where ADAS DZP (p value = 0.001) was administered showed significant impact as well but diarrhea, vomiting, cramps were some associated symptoms with Donepezil. The objective parameters TNF a and IL 10 were also performed but they did not show any gross significant changes in this short duration of treatment.
Conclusions: Although the trail was of short duration but Brahmi Ghrita was found to modestly improve cognition, activities of daily living and global clinician rating of patients with mild to moderate cognitive impairment due to Alzheimer’s. The stabilizing effect of Brahmi Ghrita on cognitive ability from this explorative study suggests its promising efficacy and should be further evaluated in future studies.