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.

AYUSH- 64: A potential therapeutic agent in COVID-19.

Corona Virus disease (COVID-19) has become a global pandemic resulting in large scale morbidity and mortality worldwide. The management of COVID-19 has been a big challenge because of multifactorial pathophysiology and no specific treatment. AYUSH-64, a poly-herbal formulation developed by CCRAS, Ministry of AYUSH, Govt. of India through extensive pharmacological, toxicological and clinical studies has proven its safety and efficacy in infective febrile conditions such as malaria and influenza. AYUSH- 64 has four ingredients having immunomodulatory, anti-inflammatory, antipyretic, antioxidant and anti-viral activities. It arrests the extreme inflammatory responses in COVID-19 that causes progression to significant morbidity. AYUSH-64 has also been incorporated in the National COVID management protocol based on Ayurveda and Yoga by Government of India for asymptomatic and mild cases of COVID-19. Further, on the basis of tangible evidence generated through robust clinical and experimental studies on AYUSH-64, the Ministry of AYUSH has launched nation-wide campaign for mass distribution of AYUSH-64 to asymptomatic, mild to moderate COVID-19 patients in home isolation to reduce the burden on the hospital. This review will highlight the specifications of AYUSH-64, its mechanism of action, its repurposing for COVID-19, various clinical and experimental studies.

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.

Mobile App-Reported Use of Traditional Medicine for Maintenance of Health in India During the COVID-19 Pandemic: Cross-sectional Questionnaire Study.

BACKGROUND: India follows a pluralistic system for strategic and focused health care delivery in which traditional systems of medicine such as Ayurveda, yoga and naturopathy, Unani, Siddha, Sowa Rigpa, and homoeopathy (AYUSH) coexist with contemporary medicine, and this system functions under the Ministry of AYUSH (MoA). The MoA developed a mobile app, called AYUSH Sanjivani, to document the trends of the use of AYUSH-based traditional and holistic measures by the public across India. Analysis of the data generated through this app can help monitor the extent of the use of AYUSH measures for maintenance of health during the COVID-19 pandemic and aid effective health promotion and communication efforts focused on targeted health care delivery during the pandemic. OBJECTIVE: The purpose of the study was to determine the extent of use of AYUSH measures by the public in India for maintenance of health during the COVID-19 pandemic as reported through the AYUSH Sanjivani mobile app. METHODS: Cross-sectional analysis of the data generated through the Ayush Sanjivani app from May 4 to July 31, 2020, was performed to study the pattern and extent of the use of AYUSH-based measures by the Indian population. The responses of the respondents in terms of demographic profile, use pattern, and benefits obtained; the association between the use of AYUSH-based measures and symptomatic status; and the association between the duration of use of AYUSH-based measures and the outcome of COVID-19 testing were evaluated based on bivariate and multivariate logistic regression analysis. RESULTS: Data from 723,459 respondents were used for the analysis, among whom 616,295 (85.2%) reported that they had been using AYUSH measures for maintenance of health during the COVID-19 pandemic. Among these 616,295 users, 553,801 (89.8%) either strongly or moderately agreed to have benefitted from AYUSH measures. Ayurveda and homeopathic measures and interventions were the most preferred by the respondents across India. Among the 359,785 AYUSH users who described their overall improvement in general health, 144,927 (40.3%) rated it as good, 30,848 (8.6%) as moderate, and 133,046 (40.3%) as slight. Respondents who had been using AYUSH measures for less than 30 days were more likely to be COVID-19-positive among those who were tested (odds ratio 1.52, 95% CI 1.44-1.60). The odds of nonusers of AYUSH measures being symptomatic if they tested positive were greater than those of AYUSH users (odds ratio 4.01, 95% CI 3.61-4.59). CONCLUSIONS: The findings of this cross-sectional analysis assert that a large proportion of the representative population practiced AYUSH measures across different geographic locations of the country during the COVID-19 pandemic and benefitted considerably in terms of general well-being, with a possible impact on their quality of life and specific domains of health.

Overview of Ayurveda trials registered with Clinical Trial Registry-India: Need for customized data set items.

Background: Lack of research data is one of the major challenges identified in traditional medicine (TM). Further, there is an urgent need to strengthen and streamline clinical research processes as well as develop research databases in TM. The Clinical Trials Registry-India (CTRI), a free, online primary register of the WHO's International Clinical Trials Registry Platform, undertakes registration of all clinical trials being conducted in India, including TM trials. However, as the CTRI data set items are primarily designed to capture information of interventional trials of the conventional system of medicine, key fields relevant to the TM system are not adequately captured in the CTRI. Aims and Objectives: The current study was conceptualized with the objective to review the type and quality of trials registered in the CTRI as well as identify the specific data set items in CTRI which may be customized as per Ayurveda studies. Materials and methods: The trials registered from July 1, 2018, to March 31, 2020, were analyzed to decipher the kind of research being undertaken in the field of Ayurveda. These trials were manually reviewed independently by two Ayurveda reviewers to gain insights into the discrepancies. Along with these analysis, brainstorming sessions with Ayurveda experts were also held. Results: The fields which were identified and need tweaking and customization were the fields "health condition" and "intervention/comparator agent." Conclusions: These modifications in the CTRI would enable the capture of more effective Ayurveda-specific information which would in turn help to standardize and streamline research practices as well as raise the standard of research.