ABSTRACT
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.
ABSTRACT
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 (nâ¯=â¯15,992), participants received GG 1â¯g daily for 28 days in conjunction with standard preventive guidelines (SPG), while in the control group (nâ¯=â¯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.
ABSTRACT
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.
ABSTRACT
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.