Ayush [Indian System of Medicines] Prophylaxis Against COVID-19: A Living Systematic Review and Meta-Analysis (Second Update).

Background: Ayush (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) system of medicine has been extensively used in India for the prevention and management of coronavirus disease 2019 (COVID-19). The present report is the second update of a living systematic review and meta-analysis and has been intended to assess the preventive potential and safety of Ayush drugs against COVID-19. Methods: A search of databases such as PubMed, the Cochrane central register of controlled trials, the World Health Organization (WHO) COVID-19 database, the clinical trial registry-India, the AYUSH research portal, and preprint repositories was performed till March 1, 2023. Randomized controlled trials or analytical observational studies were included. Incidences of COVID-19 infections and mortality were taken as primary outcome measures; and symptomatic severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection, incidences of hospital admissions, and adverse events were taken as secondary outcomes. The risk of bias was evaluated by version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB-2) and the Risk of Bias in Non-Randomized Studies-of Interventions (ROBINS-I) tool. Data were synthesized through the RevMan 5.4 tool, and the certainty of the evidence was ranked through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: Out of 2350 articles, 15 studies were included in the review. The pooled estimate of Guduchi [Tinospora cordifolia (Thunb.) Miers], Chyawanprasha, and Ayuraksha kit was obtained. Meta-analysis of the data suggested that Guduchi may reduce the incidences of COVID-19 infections (risk ratio [RR]: 0.67 [95% confidence interval, CI: 0.48-0.95]) and the symptom development among the infected (RR: 0.88 [95% CI: 0.73-1.08]), however, no change was observed in hospital admissions (RR: 0.96 [95% CI: 0.20-4.53]). It is uncertain that Chyawanprasha reduces the incidence of COVID-19 infection (RR: 0.28; [95% CI: 0.07-1.08]). Ayuraksha kit as chemoprophylaxis may reduce the incidences of COVID-19 infections (RR: 0.49; [95% CI: 0.32-0.77]). The certainty of the evidence was low to moderate mainly due to the serious risk of bias. Conclusion: Prophylactic use of Ayush medicines for populations at risk may help to prevent COVID-19 infection by reducing incidence and severity. However, considering the certainty and fewer studies, high-quality studies are still desired to confirm the efficacy and safety of Ayush chemoprophylaxis for COVID-19. Nevertheless, this update will serve as a torchbearer for policymakers, physicians, and other stakeholders for their decision-making through evidence-based medicine.

AYUSH (Indian System of Medicines) Therapeutics for COVID-19: A Living Systematic Review and Meta-Analysis (First Update).

Background: In India, alternative and complementary therapies (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy [AYUSH] medicines) are extensively utilized in COVID-19 management, and some were investigated clinically. This study assessed the effectiveness of AYUSH therapeutic on COVID-19 through a living systematic review and meta-analysis approach. Methods: Databases like PubMed; the Cochrane central register of controlled trials; WHO COVID-19 database; the central trial registry-India; Digital Helpline for Ayurveda Research Articles and AYUSH research portal, and preprint repositories were searched till August 1, 2021. Randomized controlled trials or analytical observational studies were included only. Primary outcomes selected were clinical improvement, WHO ordinal scale, viral clearance, and mortality, whereas secondary outcomes were the use of O2 therapy or mechanical ventilator, admission to high dependency unit or emergency unit, duration of hospitalization, the time to symptom resolution, and adverse events. The risk of bias was evaluated by Version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB-2) and Risk of Bias in Nonrandomized Studies-of Interventions (ROBINS-I) tools; data were synthesized through RevMan 5.4 tool, and the certainty of the evidence was ranked through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: Of 3609 studies retrieved, 17 were included in the systematic review, and 3 AYUSH therapeutics were meta-analyzed. Meta-analysis suggested that add-on AYUSH-64 likely provides therapeutic benefits by reducing time to symptom resolution (mean difference [MD] 2.35 days lower [95% confidence interval, CI; 4.05 lower to 0.65 lower]) and hastening clinical improvement (365 more per 1000 [95% CI; 4 more to 1000 more]) in mild-to-moderate COVID-19 patients. Kabasura Kudineer adjuvant to standard care is likely to reduce symptom resolution (MD; 1.93 days lower [95% CI; 2.28 lower to 1.58 lower]) and hospital stay (MD; 4.2 days lower [95% CI; 4.97 lower to 3.43 lower]) in mild-to-moderate COVID-19 patients. Co-administration of Guduchi (Tinospora cordifolia [Willd.] Miers.) to standard care may reduce the duration of hospitalization (MD; 3.93 days, lower [95% CI; 8.83 lower to 0.97 higher]) in mild-to-moderate COVID-19 patients. Furthermore, all three agents seemed safe in adjunct usage to standard care. The certainty of evidence for most outcomes was moderate to low, primarily due to the high risk of bias or imprecision owing to the small sample size. Conclusion: Rational use of integrated or standalone AYUSH interventions in mild-to-moderate COVID-19 patients is safe and may provide therapeutic benefits. The effect estimates may be changed with additional evidence in upcoming updates.

Impact of AYUSH 64 as an adjunctive to standard of care in mild COVID 19 - An open-label randomized controlled pilot study.

Background: Ayurveda herbal formulation AYUSH-64, proven to treat malaria and influenza-like illness in india was repurposed for COVID-19 patients considering preliminary evidances, however, scientific data was not available. Aim: To evaluate the preliminary efficacy and safety of AYUSH 64 as an add-on to standard of care in mild COVID19 patients. Materials and methods: A single centre, randomized, open-labeled, controlled, pilot study were conducted on mild COVID 19 confirmed patients. Patients allotted in interventional group (n = 41) recieved AYUSH 64, 3 gm per day in three divided dose for 14 days as an adjuvant to standard of care (SOC) whereas control group received SOC (n = 39) alone. Outcomes were reduction in WHO ordinal scale for clinical improvement, all-cause mortality, incidence of COVID19 symptoms among asymptomatic patients at baseline, use for oxygen therapy, use for a mechanical ventilator, the total duration of symptomatic phase and adverse events. Results: Mean score of WHO ordinal scale was reduced as time lapse in both the groups (f (1) = 20.5, p < 0.001) indicating clinical improvement among groups. There was no statistically significant difference in mean WHO ordinal scale between groups (f (1) = 0.98, p = 0.32). The proportion of asymptomatic patients progressing to the symptomatic stage is lower in AYUSH 64 group [OR, 0.68 (CI, 0.17-2.66)]. Mean days for the total duration of the symptomatic phase was also short in AYUSH 64 group (4.68 ± 3.29 days) compared to SOC group (5.81 ± 3.5 days). No incidence of the requirement of a mechanical ventilator, adverse drug reaction and death were observed in either of the groups. Conclusion: The findings of this pilot study show that an integrated approach of AYUSH 64 with SOC provide early trends of benefit by reduction in disease progression and in total symptom duration. However, its effects remains inconclusive on outcomes such as all cause mortality, use of oxygen therapy, invasive ventilator due to sparse outcomes.

Guduchi Ghanavati (Ayurveda medication) improves the perceived immunity in individuals at risk of SARS-CoV-2: A Multicentred, controlled, before-and-after study.

Introduction During the COVID-19 pandemic in India, Ayurvedic medication (Guduchi Ghanavati, GG) was prescribed by Ayurveda physicians for prevention and management. This study aimed to evaluate the prophylactic effect of GG in individuals with moderate to very high risk of SARS-CoV-2. Methods A multicenter, controlled, quasi-experimental, before-and-after study was conducted on individuals at moderate to very high risk of SARS-COV-2 exposure. In the intervention group (n = 15,992), participants received GG 1 g daily for 28 days in conjunction with standard preventive guidelines (SPG), while in the control group (n = 4953), participants were asked to follow SPG only. Outcomes were the incidence of COVID-19, perceived immune status, quality of life, and safety. The perceived immune status was assessed using a brief Likert-scale questionnaire having common immune-related complaints. Results Of the 20,945 enrolled, 20,574 completed the trial (intervention: 15,729, control: 4845). The percentage of participants who reported the incidence of COVID-19 was marginally lower in the GG+SPG group (41, 0.26%) than in the SPG group (16, 0.33%), leading to 21% (95% CI, -40% to 55%) efficacy of GG. However, the decrease in incidence percentage was statistically insignificant due to the trivial incidences reported. The scores of perceived immune status quality of life improved significantly from baseline in the GG+SPG group (p < 0.001) compared to the SPG group. Conclusion GG is safe and improves perception of immune status in individuals at risk of developing SRAS-CoV-2. However, these findings are inadequate to establish that GG lowers the incidence of COVID-19 necessitating to conduct RCTs in high-risk populations. Clinical Trial Registration CTRI/2020/06/025,525.

Ayurveda intervention for brass-induced heavy metal toxicity: A report from the single-arm pilot study.

BACKGROUND: Brass is a copper-zinc alloy that also contains additional elements, including lead. Industrial operations on brass produce dust and fumes that can be harmful to an individual's health. Ayurveda recommends Dadima Svarasa and Triphala Churna for the management of symptoms caused due to brass toxicity. OBJECTIVE: To obtain preliminary evidence on the efficacy of Triphala Churna (powder mixture of three myrobalans) and Dadima Svarasa (pomegranate juice) in the management of brass-associated high serum level of copper, zinc, lead, and their harms through an open-label single-arm pilot study. MATERIALS AND METHODS: A total of 20 workers with brass toxicity and increased level of one or more of the serum ions including copper, zinc and lead were prescribed. 5gm Triphala powder once daily and Dadima Svarasa 40 ml in two divided doses were administered daily for 28 days. Changes in serum concentration of heavy metals and common health problems like anorexia, headache, dizziness, weakness, nausea, nose irritation, eye irritation, epigastric pain, abdominal distention, chest pain, dyspnea, cough, lumbar pain, body ache, numbness, and occupational dermatitis were reported at baseline and end of the trial. RESULTS: Trial drugs were found to produce significant decrease in mean values of serum copper (p < 0.001) and serum lead (p < 0.001) whereas significant increase in mean values of serum zinc (p > 0.001) was observed. Significant relief was observed in nausea (p = 0.005), anorexia (p = 0.000), epigastric pain (p = 0.001), abdominal distention (p = 0.014), weakness (p = 0.005) and body ache (p = 0.005). CONCLUSION: Triphala Churna along with Dadima Svarasa are safe and effective in the management of brass-associated high serum levels of copper and lead and their health hazards.

Add-on Ayurveda Treatment for Early Stage COVID-19: A Single Center Retrospective Cohort Study From Gujarat, India.

The retrospective cohort study aimed to evaluate the clinical outcomes of Ayurveda treatment exposure as an add-on to conventional care in early stage COVID-19 patients admitted at Samaras COVID care center, Ahmedabad, India. Conventional care included Vitamin-c, Azithromycin, and Paracetamol. Ayurveda formulations used as add-on were Dashamula and Pathyadi decoctions along with Trikatu powder, Sanshamani tablet, AYUSH-64 tablet AND Yastimadhu Ghana tablet for oral administration. Considering Add-on Ayurveda medicines as exposure of interest, patients who received Add-on Ayurveda medicines at least for 7 days were included in the exposed group while those who received only conventional care in unexposed group. Data was collected through record review and telephonic interviews. The outcomes of interest were the development of symptoms, duration of symptomatic phase in those progressing to symptomatic stage and mortality. Total 762 participants were included-[541 (71%) in the exposed group and 221 (29%) in the unexposed. Progression to symptomatic phase did not differ significantly between groups [27.6% in exposed, 24.6% in unexposed, adjusted RR 0.85; 95% CI 0.6-1.2]. The total duration of symptomatic phase among those progressing to the symptomatic stage was significantly decreased in the exposed group (x¯ = 3.66 ± 1.55 days in exposed (n = 133); x¯ = 5.34 ± 3.35 days in unexposed (n = 61), p < 0.001). No mortality was observed in either of the groups. Ayurveda Treatment as adjunctive to conventional care reduced the duration of symptomatic phase in early stage COVID-19 as compared to standalone conventional care. Add-on Ayurveda treatment has promising potential for management of early stage COVID-19.

Impact of AYUSH interventions on COVID-19: a protocol for a living systematic review and meta-analysis.

Background: The coronavirus disease 2019 (COVID-19) pandemic has created a great burden on governments and the medical fraternity globally. Many clinical studies from the Indian system of Traditional Medicines [Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH)] have been carried out to find appropriate solutions. Through a living systematic review and meta-analysis, this study aims to determine the effectiveness of the Traditional System of Indian Medicine (AYUSH system) in lowering the incidence, duration, and severity of COVID-19. Methods: We will search the following databases: Pubmed; the Cochrane central register of controlled trials (CENTRAL); the Clinical Trials Registry - India (CTRI); Digital Helpline for Ayurveda Research Articles (DHARA); AYUSH research portal; Google scholar and World Health Organization (WHO) COVID-19 database. Clinical improvement, WHO ordinal scale, viral clearance, incidences of COVID-19 infection, and mortality will be considered as primary outcomes. Secondary outcomes will be use of O2 therapy or mechanical ventilator, admission to high dependency unit or emergency unit, duration of hospitalization, the time to symptom resolution, and adverse events. Data will be synthesized, with RevMan 5.4 tool and the risk of bias will be assessed with RoB 2 (for RCTs) and ROBINS I (for NRSIs). Certainty of evidence will be assessed through the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) tool. The review will be updated bi-monthly with two updates. Conclusion: This living systematic review will be the first to address AYUSH interventions in COVID-19, synthesizing the full spectrum of Indian Traditional System of Medicine against COVID-19. It will facilitate professionals, guideline developers, and authorities with up to date synthesis on interventions periodically to make health-care decisions on AYUSH therapies in the management of COVID-19.

Central nervous system depressant activity of Jatamansi (Nardostachys jatamansi DC.) rhizome.

Background: Sleep disorders have a comparatively high prevalence worldwide and create a burden on the health system. Pharmacological agents used for insomnia are associated with considerable side effects. Therefore, searching for safe and effective agents from plant-based natural sources is a worthy effort. Jatamansi (Nardostachys jatamansi DC.) rhizome has been recommended for insomnia and mental conditions in the Indian system of medicine. Aim: This study aimed to determine central nervous system (CNS) depressant activity of Jatamansi (N. jatamansi) rhizome on experimental animals. Materials and methods: Gross behavior study and open field test (locomotor activity) were performed by using Charle's foster albino rats whereas rota-rod test and pentobarbital-induced sleep test in Swiss albino mice. Animals were divided into 3 groups (per model) having six animals in each group. The control group was treated with water, the standard group with diazepam and the test drug with powder of N. Jatamansi rhizome. Results were calculated by one-way ANOVA and post hoc test with P < 0.05 as significant. Results: Data suggested that Jatamansi did not produce a significant effect on the behavior of animals. It reduced the horizontal activity significantly (P < 0.001) in the open field apparatus. The test drug did not show a significant decrease in latency of fall-off time in rota-rod performance in mice. Still, it exerted a significant effect by a reduction in latency of onset of sleep (P < 0.01) and also extended the total duration of sleep (P < 0.05) in albino mice in comparison to the control group. Conclusion: This study shows that Jatamansi rhizome powder possesses CNS depressant activity without affecting gross behavior and muscle coordination in rats.

Consequences of excessive use of Amlarasa (sour taste): A case-control study.

BACKGROUND: Palatability is an important factor for choice of food by an individual. Amlarasa (sour taste) is one of the main organoleptic entities in foods of present day, which always tempts the consumer to take it now and then. According to classical Ayurvedic texts, balanced intake of Amlarasa in diet helps to maintain physiological health, but its excessive intake produces some signs and symptoms such as dentine hypersensitivity, stomatitis, halitosis, heartburn, urticaria, papule and joint inflammation. AIM: To establish the relationship between excessive use of sour predominant diets and signs/symptoms produced by it. MATERIALS AND METHODS: A case-control survey study was designed wherein total of 178 volunteers were interviewed personally. Subjects with particular symptoms consider as a cases while healthy volunteers as controls. To measure the excessive intake of Amlarasa, quantity and frequency of common food articles such as mango, tomato, lime, butter milk, tamarind, curd, fermented items etc., are taken into consideration. Data was arranged in to 2 × 2 table and odd ratio was calculated for each symptom. RESULTS: Odds ratio for dentine hypersensitivity, stomatitis, halitosis, heartburn, urticaria, papule and joint inflammation with 95% confidence interval were found 1.95 (0.97-3.93), 2.45 (1.12-5.40), 2.76 (0.96-7.98), 2.21 (1.09-4.53), 0.86 (0.32-2.32), 2.28 (1.02-5.05) and 4.85 (1.09-10.24) respectively. CONCLUSION: Study reveals that Amlarasa is a risk factor for joint inflammation, dentine hypersensitivity, stomatitis, halitosis, heartburn and papules. Study supports the Ayurvedic classical claim regarding Atiyoga of Amlarasa.