Efficacy and safety of AYUSH-64 as standalone or adjunct to standard care in COVID-19: a structured summary of protocol for a systematic review.

TRIAL REGISTRATION: Registered with PROSPERO ( CRD42021267844 ) dated 14.07.2021.

AYUSH 64, a polyherbal Ayurvedic formulation in Influenza-like illness - Results of a pilot study.

BACKGROUND: Influenza-like Illness (ILI) refers to a wide range of viral infections with an important cause of morbidity and mortality worldwide. The global incidence of ILI is estimated at 5-10% in adults and 20-30% in children. In India influenza accounts for 20-42% of monthly acute medical illness hospitalizations during the peak rainy season. AYUSH-64, a poly-herbal drug, is in practice for 40 years for various clinical conditions like fevers, microfilaremia, and inflammatory conditions. OBJECTIVE: A pilot study was conducted to evaluate the safety and efficacy of Ayurvedic formulation, AYUSH-64 in clinically diagnosed ILI for accelerating the recovery. MATERIAL AND METHODS: A prospective, open-label, nonrandomized, single group, single-center pilot clinical study with pre-test and post-test design was conducted at Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute for Cancer, Mumbai, an institute of Central Council for Research in Ayurvedic Sciences (CCRAS) between June 2018 and July 2019. A total of 38 participants of clinically diagnosed ILI (18-65 years) were studied with an one-week intervention of 'AYUSH 64' in a dose of 3 gm/day and three weeks post-treatment observation period. Assessment of parameters viz. improvement in the symptoms of ILI, frequency of usage of acetaminophen, antihistaminic and cough syrup, hematology, liver function and kidney function tests along with incidence of secondary complications, and time to return to a normal routine was done. RESULTS: One-week intervention of AYUSH 64 helped to recover from ILI symptoms with reduced frequency of usage of acetaminophen and antihistaminic. The intervention was safe on hematology and biochemical parameters. No serious adverse effects were observed during the study. CONCLUSION: AYUSH 64 along-with standard care in ILI is safe and efficacious and this may be used in other viral infections with pyrexia as add-on to standard care for early recovery and better outcome.

Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: Primary Objective • To assess the efficacy of Ayurveda interventions and Yoga in rehabilitation of COVID-19 cases suffering with long term effects of COVID 19 as compared to WHO Rehabilitation Self-Management after COVID-19- Related Illness. Secondary Objective • To assess the safety of Ayurvedic interventions in cases suffering with long term effects of COVID 19 TRIAL DESIGN: Multi-centric, randomized, controlled, parallel group, open-label, exploratory study. The study duration is 9 months and the intervention period is 90 days from the day of enrolment of the participant. PARTICIPANTS: Patients of either sex between 18 to 60 years, ambulatory, willing to participate, with history (not more than 4 weeks) of positive RT-PCR for COVID-19 or IgM antibodies positivity for SARS CoV-2, but having negative RT-PCR for COVID-19 at the time of screening will be considered eligible for enrolment in the study. Critically ill patients with ARDS (acute respiratory distress syndrome), requiring invasive respiratory support in the intensive care unit, known case of any malignancy, immune-compromised state (e.g. HIV), diabetes mellitus, active pulmonary tuberculosis, past history of any chronic respiratory disease, motor neuron disease, multiple sclerosis, stroke, impaired cognition, atrial fibrillation, acute coronary syndrome, myocardial infarction, severe arrhythmia, concurrent serious hepatic disease or renal disease, pregnant or lactating women, patients on immunosuppressive medications, history of hypersensitivity to the trial drugs or their ingredients, depressive illness (before COVID-19), diagnosed psychotic illnesses, substance dependence or alcoholism will be excluded. The trial will be conducted at two medical colleges in Maharashtra, India. INTERVENTION AND COMPARATOR: Intervention Arm (Group-I): Ayurveda interventions including Agastya Haritaki six gram and Ashwagandha tablet 500 mg twice daily orally after meals with warm water and two sessions of yoga (morning 30 minutes and evening 15 minutes) daily for 90 days, as per the post-COVID-19 care protocol provided in National Clinical Management Protocol based on Ayurveda and Yoga for management of COVID-19 published by Ministry of AYUSH, Government of India. Comparator Arm (Group-II): WHO Rehabilitation Self-Management after COVID-19 related illness for 90 days. The trial drugs are being procured from a GMP certified pharmaceutical company. MAIN OUTCOMES: Primary Outcome: Change in respiratory function to be assessed by San Diego shortness of breath Questionnaire, 6-minutes walk test and pulmonary function test. SECONDARY OUTCOMES: Change in High-resolution Computed Tomography (HRCT) Chest Change in Fatigue score assessed by Modified Fatigue Impact Scale Change in Anxiety score assessed by Hospital Anxiety and Depression Scale Score Change in Sleep Quality assessed by Pittsburgh Sleep Quality Index Change in the quality of life assessed by COV19-QoL scale Safety of the interventions will be assessed by comparing hematological and biochemical investigations before and after the intervention period and Adverse Event/ Adverse drug reaction TIMELINES FOR OUTCOME ASSESSMENT: Subjective parameters and clinical assessment will be assessed at baseline, 15th day, 30th day, 60th day and 90th day. Laboratory parameters (CBC, LFT, KFT, HbA1c, Hs-CRP, D-dimer), Pulmonary function test and HRCT Chest will be done at baseline and after completion of study period i.e. 90th day. RANDOMISATION: Statistical package for Social Sciences (SPSS) version 15.0 is used to generate the random number sequences. The participants will be randomized to two study groups in the ratio of 1:1. BLINDING (MASKING): The study is open-label design. However, the outcome assessor will be kept blinded regarding the study group allocation of the participants. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) SAMPLE SIZE: The sample size for the study is calculated assuming improvement in 6-minutes walk test by 40 meter in Group I and a change of 10 meter in Group II with a standard deviation of 50 meter based on the results of the previous studies, with 95% Confidence Level (α = 0.05) and 80% power and expecting a dropout rate of 20%. The number of participants to be enrolled in the study should be approximately 55 in each group. Hence, a total of 110 participants will be enrolled in the trial at each study site. TRIAL STATUS: Participants' recruitment started on 1st May 2021. Anticipated end of recruitment is August 2021. Protocol number: CCRAS-01 Protocol version number: 1.1, 13th January 2021. TRIAL REGISTRATION: The trial is prospectively registered with the Clinical Trial Registry of India (CTRI) on 03rd March 2021 [ CTRI/2021/03/031686 ]. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Journal website (Additional file 1). This communication serves as a summary of the key elements of the full protocol.

Review of health-care services for older population in India and possibility of incorporating AYUSH in public health system for geriatric care.

BACKGROUND: In a developing country like India, which has 10.11% population of >60 years age and a projection of rise of the same by 300% in 2050, health care of elderly is an enormous challenge. The developed world has evolved many models for elderly care, for example, nursing home care, health insurance, etc. Indian Government has also taken multiple measures in this direction by initiating National Policy on Older Persons, 1999, the Maintenance and Welfare of Parents and Senior Citizens Act, 2007, the Old Age Pension Scheme, Rashtriya Vayoshri Yojana 2017, etc. However, there is a necessity that, India must rapidly adapt to the complex health related, social and economic challenges caused by these demographic changes. This may be an opportunity for innovation in the health system by developing a perspective for healthy and active aging, though it is a major challenge. Health care of the older people cannot be achieved unless total health, i.e., physical, social, economic, psychological, and spiritual aspects are addressed. OBJECTIVE: The objective is to study current policies regarding geriatric health care in India and to propose the possibility to develop a model to provide comprehensive and dedicated health-care services to the older population by integrating conventional and indigenous systems of medicine dwelling in the country. MATERIALS AND METHODS: Electronic search in various scientific journals for research and review articles; electronic along with hand searching of conference proceedings, brochures, government policy documents, press releases, Ayurveda classical texts, etc., regarding geriatric health care in India and model health-care facilities in other countries and regarding of AYUSH systems in geriatric health care in India. RESULTS: There is an urgent need of adaptation and modification in the National Health System to cater the actual requirements of the elderly with plans and strategies dedicated to face their health-related challenges. Adoption of inclusive health-care interventions, can improve health outcomes by making it more acceptable, accessible, and affordable. CONCLUSION: Integration of AYUSH at various levels of health-care delivery system can potentially contribute to provide unique newer dimensions to the field of geriatric care in India.