Varanasi: A group of physician-scientists at Banaras Hindu University recently completed the world’s first published Ayurvedic N-of-1 clinical trial. An N-of-1 clinical trial is a highly personalised research design where a single patient serves as the entire study. In this study, Ayurveda’s classical formulation ‘Kalyanaka Ghrita’ was evaluated in a patient suffering from mild cognitive impairment (MCI). This study lasted for about 14 months. Bayesian statistics indicated signs of improvement in the patient’s memory, cognitive functioning, activities of daily living and depression. The researchers also clarified that any Ayurvedic medicine should be consumed only under the consultation and supervision of a trained Ayurveda physician. With increasing age, memory and cognitive abilities gradually begin to decline in many people. When this starts affecting a person’s daily life, the condition is called dementia. The early stage of dementia is known as MCI. Research on the treatment of Alzheimer’s-related dementia and MCI is being conducted worldwide, but the medicines currently available are not fully effective. India’s ancient Ayurvedic system of medicine can make a special contribution in chronic diseases like dementia. Prof Kishor Patwardhan of the department of kriya sharir, faculty of Ayurveda, Institute of Medical Sciences, BHU, is the principal investigator of this study, and the co-principal investigator is Prof Shankh Shubhra Chakravarty of the department of geriatric medicine, faculty of medicine, Institute of Medical Sciences. The other authors of the study are Swati Sharma, a researcher in the department of Kriya Sharir, and Dr Arun Kaushik, assistant professor in the department of statistics, Institute of Science.Prof Patwardhan said that Kalyanaka Ghrita is a polyherbal formulation of Ayurveda. In it, many medicinal substances including harad, amla, baheda, devdar, haldi, jatamansi, anar and chandan are processed in ghrita. In Ayurveda, it has traditionally been considered useful for memory, intellect and mental health. Today, in medical research, randomised controlled trials (RCTs) are considered one of the most reliable scientific methods for evaluating the effectiveness of treatments. Nevertheless, they have their own limitations. Most RCTs assess the average effect of treatment at the group level, whereas Ayurveda’s approach is personalised. For this reason, many researchers believe that N-of-1 clinical trials can prove useful in evaluating a personalised system of medicine like Ayurveda. Although the need for N-of-1 clinical trials in Ayurveda has been discussed for a long time, very few practical studies have been published in this direction so far. This study is important because it makes it clear that the scientific evaluation of Ayurvedic medicines can also be done through N-of-1 clinical trials. In the future, if many such N-of-1 clinical trials are conducted and their results are collectively analysed, new paths for building scientific evidence in Ayurveda can open up. This can help in better understanding Ayurveda’s personalised system of medicine from a scientific perspective and in developing more robust scientific evidence in its support. This study was completed through the multidisciplinary collaboration of experts from the university’s faculties of Ayurveda, medicine and science. This study was recently published in the Journal of Ethnopharmacology, which is one of the leading international scientific journals in the field of traditional medicine.binays01@gmail.com
