Co-administration of AYUSH 64 as an adjunct to standard of care in mild and moderate COVID-19: A randomized, controlled, multicentric clinical trial.

OBJECTIVE: Evaluate the efficacy of AYUSH 64, a standard polyherbal Ayurvedic drug in COVID-19. METHODS: During the first pandemic wave, 140 consenting and eligible hospitalized adult participants with mild-moderate symptomatic disease (specific standard RT-PCR assay positive) were selected as per a convenience sample, and randomized (1:1 ratio) to an open-label (assessor blind) two-arm multicentric drug trial; standard of care (SOC as per Indian guidelines) versus AYUSH 64 combined with SOC (AYUSH plus). Participants were assessed daily and discharged once clinical recovery (CR, primary efficacy) was achieved which was based on a predetermined set of criteria (resolution of symptoms, normal peripheral oximetry, and negative specific RT-PCR assay). Each participant was followed using an indigenous software program(mobile phone) and completed a 12-week study period. The dose of AYUSH 64 was 2 tablets oral, 500 mg each, bid for 12 weeks (AYUSH plus only). Significant P was <0.05 (two-sided). On randomization, the groups were found well matched. RESULTS: The mean interval time from randomization to CR was significantly superior in the AYUSH plus group [mean 6.45 days versus 8.26 days, 95% Confidence Interval of the difference -3.02 to -0.59 (P = 0.003, Student's 't test] as per-protocol analysis (134 participants); significant (P = 0.002) on an intention to treat analysis. 70% of the participants in AYUSH plus recovered during the first week (P = 0.046, Chi-square) and showed a significantly better change in physical health, fatigue, and quality of life measures. 48 adverse events, mostly mild and gut related, were reported by each group. There were 20 patient withdrawals (8 in AYUSH plus) but none due to an AE. There were no deaths. Daily assessment (hospitalization) and supervised drug intake ensured robust efficacy data. The open-label design was a concern (study outcome). CONCLUSIONS: AYUSH 64 in combination with SOC hastened recovery, reduced hospitalization, and improved health in COVID-19. It was considered safe and well-tolerated. Further clinical validation (Phase III) is required. TRIAL REGISTRATION: CTRI/2020/06/025557.

Bariatric Nutrition Guidelines for the Indian Population.

BACKGROUND: Bariatric surgery numbers have seen a sharp rise in India in the last decade. A country known for its undernourished population has seen economic growth and with it, greater influence of western culture and foods. The obesity epidemic is on the rise here and India is one of the 10 most obese nations of the world being second only to China in the number of type 2 diabetes. Nutritionists in India often rely on recommendations and guidelines meant for the Caucasian population. Religious and cultural practices influence the dietary habits and patterns of the Indian population to a great extent; because of which the nutritional requirements are very different. This document was put together with an aim to provide nutritionists with recommendations on how to manage the Indian bariatric patient. METHODS: A bariatric nutrition round table meeting was initiated by the Centre for Obesity and Digestive Surgery (CODS) to bring together experts in the field of bariatric nutrition to review current data on nutritional deficiencies in the morbid obese and existing post-operative deficiencies and to formulate nutritional recommendations for bariatric/metabolic surgery specific to patients from India. RESULTS: Percentage of nutritional deficiencies and reasons for the same were identified among the Indian population and recommendations were made to suit this particular population. CONCLUSION: It is recommended that all patients undergo compulsory pre-operative nutritional counseling and nutritional investigations and that nutritional follow-up be continued lifelong. In addition, long-term implications like hypoglycemia, dumping syndrome, sugar cravings, and weight regain, need to be picked up and managed efficiently. Most importantly, post-operative supplementation is a must irrespective of type of surgery.