Ashwagandha (Withania somnifera) and Shunthi (Zingiber officinale) in mild and moderate COVID-19: An open-label randomized controlled exploratory trial.

BACKGROUND: Ayurveda interventions have been used for prophylaxis and care during the COVID-19 pandemic in India and have shown promising results in promoting early clinical recovery from COVID-19. OBJECTIVE: To assess the efficacy and safety of Ashwagandha [Withania somnifera (L.) Dunal] tablet and Shunthi (Zingiber officinale Roscoe) capsule in mild and moderate COVID-19 compared to conventional standard care. METHODS: A randomized controlled exploratory trial was conducted at a designated COVID-19 care center in India with 60 participants having mild or moderate COVID-19. Ashwagandha, two tablets (250 mg each), and Shunthi, two capsules (500 mg each) twice daily for 15 days, were given orally to the participants in the Ayurveda group (AG) and the control group (CG) received conventional standard care. The outcome measures included clinical recovery rate, the proportion of participants with negative RT-PCR assay for COVID-19 on day 7 and day 15, mean time to attain clinical recovery, change in pro-inflammatory markers, serum IgG for COVID-19, HRCT chest findings, disease progression and incidence of adverse events (AE). RESULTS: A total of 60 participants were enrolled, and the data of 48 participants (AG = 25 and CG = 23) were considered for the statistical analysis. The mean time for clinical recovery was reduced by almost 50 % in the AG (6.9 days) compared to CG (13.0 days) (p < 0.001). The proportion of participants who attained viral clearance in AG was 76.0 % compared to 60.8 % in the CG (RR= 1.24, 95 % CI: 0.841, 1.851, p-value = 0.270). Changes in the pro-inflammatory markers, serum IgG for COVID-19, and HRCT chest findings were comparable in both groups, and no AE or disease progression was reported. CONCLUSIONS: The Ayurveda interventions, Ashwagandha and Shunthi, can effectively reduce the duration of clinical recovery and improve time for viral clearance in mild and moderate COVID-19. These interventions were observed to be safe and well-tolerated during the duration of the trial. TRIAL REGISTRATION: Clinical Trial Registry of India - CTRI/2020/08/027224.

Efficacy and safety of Ayurveda interventions for sinusitis: a systematic review and meta-analysis.

OBJECTIVES: To provide a broad evaluation of the efficacy and safety of Ayurveda interventions for the management of sinusitis. METHODS: Five electronic databases for published research articles, three databases for the dissertation/doctoral thesis works, clinical trial registries, and hand searches were done till May 2021. All comparative clinical trials recruiting sinusitis patients of any age group, receiving Ayurveda intervention, regardless of forms, dosages, and ingredients, for not less than one week were included. The data extraction and the risk of bias (RoB) assessment were done by two reviewers independently. RESULTS: A total of 2,824 records were identified, of which 09 randomized parallel arms trials met inclusion criteria. No studies were found comparing Ayurveda vs. placebo or non-Ayurveda interventions. Combined Ayurveda therapy (CT) was statistically more beneficial compared with either procedural or non-procedural Ayurveda therapy alone in reducing symptoms nasal discharge (standardized MD -0.71, 95% CI -1.16 to -0.26, I 2 58%, 210 participants) and headache (standardized MD -0.44, 95% CI -0.86 to -0.02, I 2 56%, 218 participants), however, no significant difference was found in reducing symptoms nasal obstruction and loss of smell. No data related to the safety of Ayurveda intervention was found. All the trials (09) were having 'high' to 'some concern' overall bias. CONCLUSIONS: Although individual studies appeared to produce positive results, very low certainty of total effect hindered to arrive at any conclusion regarding efficacy or safety of Ayurveda interventions for sinusitis. There is a need for well-designed-executed-reported clinical studies on clinically relevant outcomes. TRIAL REGISTRATION MUMBER: CRD42018103995.

Disease Characteristics, Care-Seeking Behavior, and Outcomes Associated With the Use of AYUSH-64 in COVID-19 Patients in Home Isolation in India: A Community-Based Cross-Sectional Analysis.

Background: During the second wave of the COVID-19 pandemic in India, the Ministry of Ayush conducted a community study to provide therapeutic care to patients with asymptomatic, mild, and moderate COVID-19 in home isolation based on the empirical evidence generated on the efficacy of AYUSH-64 in COVID-19. Objective: To document disease characteristics, care-seeking behavior, and outcomes in patients with asymptomatic, mild, or moderate COVID-19 in home isolation who used AYUSH-64 for COVID-19. Methods: Cross-sectional analysis of the data generated through a community study conducted in India from 08 May to 31 August 2021 was performed to study the disease characteristics, care-seeking behavior during home isolation, clinical outcomes, adverse events, and the association between various risk factors and clinical recovery during the study period. The data were collected through semi-structured questionnaires, available in electronic data collection format at the baseline, 7, 14, and 21 days. A logistic regression was performed to explore the relationship between relevant variables and clinical recovery. Results: Data from 64,642 participants were analyzed for baseline assessment, and final analysis was done for 49,770 participants. The mean age of the enrolled participants was 38.8 ± 11.7 years, and 8.4% had co-morbidities. AYUSH-64 was utilized as an add-on to the standard care by 58.3% of participants. Comparable clinical outcomes were observed in participants utilizing AYUSH-64 either as a standalone or as an add-on to standard care, in terms of clinical recovery, disease progression, the requirement for oxygen supplementation, hospitalization, ICU admission, and need for ventilator support. Younger age, having no co-morbidities or substance abuse, and having been vaccinated were associated with early clinical recovery than those who were older and not vaccinated. Conclusions: The study findings suggest that AYUSH-64 use, either standalone or as an adjunct to standard care, in asymptomatic, mild, or moderate COVID-19 is associated with good clinical outcomes. Ayush services and interventions can be effectively integrated into the mainstream public health architecture to serve public health goals.

AYUSH-64 as an adjunct to standard care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India.

OBJECTIVE: To determine the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in mild to moderate COVID-19. DESIGN SETTING, AND INTERVENTIONS: This open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India in 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone. MAIN OUTCOME MEASURES: Proportion of participants who attained clinical recovery on day 7, 15, 23 and 30, proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point, change in pro-inflammatory markers, metabolic functions, HRCT chest (CO-RADS category) and incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE). RESULTS: Out of 80 participants, 74 (37 in each group) contributed to the final analysis. Significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. Mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG. CONCLUSIONS: AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

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.

Dhatri Lauha in the management of iron deficiency anemia: A prospective open-label single-arm multi-center trial.

Background: The burden of iron-deficiency anemia (IDA) remains persistently high in India due to the poor tolerability of oral iron supplementation. Therefore, more focus is required to explore traditional medicine for safe and effective options for managing IDA. Aim: To assess the clinical safety and efficacy of Dhatri Lauha in patients with IDA. Materials and methods: An open-label, prospective, single-arm, multi-center trial was conducted at 12 centers with a sample size of 40 participants per study site. Patients with IDA aged 18-60 years with hemoglobin levels in the range of 6-10gm/dl, mean corpuscular volume (MCV) <80 fl, mean corpuscular hemoglobin concentration (MCHC) <34 µg/dl, serum ferritin <30 µg/dl and serum iron <50 µg/dl were included in the study. Dhatri Lauha 500 mg capsule was administered twice daily with lukewarm water after meals for 45 days. The primary outcome measure was the change in hemoglobin (Hb%) level from baseline to day 45. Secondary outcome measures included the change in MCV, MCHC, serum iron and ferritin levels, incidence of adverse events, and change in safety parameters (liver and kidney function tests). The mean (statistical) change in outcome measures from baseline to day 45 was compared using a paired sample t-test. Results: Out of 458 participants enrolled in the study, 400 contributed to the final analysis. A significant difference was observed in the outcome parameters such as Hb%, MCV, MCHC, serum ferritin, and serum iron levels (P < 0.001) after 45 days of treatment. Mean Hb% changed from 8.46 ± 1.14 g/dl at baseline to 9.18 ± 1.61 g/dl on day 45 (P < 0.001). LFT and KFT were within the normal limits after the study period. No participant withdrew from the study due to adverse events. Conclusions: Dhatri Lauha is a safe intervention and can be expected to improve hemoglobin levels, red blood cell parameters, and iron stores in patients with IDA. Future RCTs with a larger sample size, standard care as control and a longer follow-up may produce more accurate and reliable results.

Swasthya Assessment Scale (SAS)-Ayurveda based health assessment tool-insights on its development and validation.

Introduction: Ayurveda has a unique way of understanding the body, health, and diseases. Various determinants, including biological, ecological, medical, psychological, sociocultural, spiritual, and metaphysical factors, which depend on each other, have their role in determining health in Ayurveda. Currently, no validated health assessment scale, based on the principles of Ayurveda is available. This article, for the first time, reports the development, validation, and reliability testing of the Swasthya assessment scale - a health assessment tool developed in Ayurveda. Materials and methods: A thorough literature search and expert consultations were done to draft the items encompassing the concept of health in Ayurveda. A group of experts assessed the content validity of the drafted items. Cognitive de-briefing and pretesting were performed to modify the language and the content again. Reliability testing was done with an inter-observer agreement in a sample of 183 individuals. Results: The content validity index for items and the scale-level content validity index (S-CVI) were calculated. S-CVI for scale was excellent, with 85% agreement. The S-CVI/universal agreement was 0.45, and S-CVI/Average was 0.95. In inter-rater reliability, the percentage agreement was 73.7%. Pearson correlation coefficient was 0.808 showing a strong correlation. Conclusion: Following appropriate validation, the scale can be widely used in clinical practice to assess the patient's health status, guide the treatment plans, and monitor the progress of the health. It can also be used as a sensitive tool in the research of Ayurveda to assess the changes in patients brought about by Ayurveda interventions.

AYUSH-64 as an add-on to standard care in asymptomatic and mild cases of COVID-19: A randomized controlled trial.

BACKGROUND: The evidence on the efficacy and safety of Ayurveda interventions as an add-on to the standard conventional care for coronavirus disease-2019 (COVID-19) is limited. AIM AND OBJECTIVE: This study was planned to explore the potential of AYUSH-64 as an add-on to conventional care in improving the clinical recovery and negative reverse transcription-polymerase chain reaction (RT-PCR) conversion in asymptomatic and mild COVID-19 cases. MATERIALS AND METHODS: An open-label randomized controlled study was conducted at Government Medical College, Nagpur, Maharashtra, India, with a sample size of 60 participants. In this study, asymptomatic or mild COVID-19 patients were randomized and allocated into intervention and control groups (CG) in a 1:1 ratio. AYUSH-64 two capsules (500 mg each) were administered thrice daily, after food with water for 30 days along with standard care in the intervention group (IG), while the CG received only standard care. The primary outcome was the proportion of participants who turned RT-PCR negative for COVID-19 at 7th, 15th, 22nd and 30th days. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd and 30th days, change in laboratory parameters on the 30th day and incidence of adverse drug reactions/adverse events. The data were compared within group using paired sample t-test/Wilcoxon signed-rank test and between group using independent sample t-test/Mann-Whitney test. RESULTS: Statistically significant difference was not observed in the proportion of participants who turned RT-PCR negative during each of the follow-ups (P = 0.134) and both groups demonstrated comparable efficacy. The clinical recovery in terms of complete relief in symptoms in the symptomatic participants was 60% and 37% on day 15 (P = 0.098) and 100% and 85.2% on day 30 (P = 0.112) in the intervention and CG, respectively. The improvement in the inflammatory markers such as interleukin (IL)-6, tumor necrosis factor-α (TNF-α), and D-dimer was statistically significant (P < 0.05) in the IG, whereas in the CG, it was statistically significant for D-dimer only. None of the participants developed any complications nor were any significant ADR/AE observed in the groups. CONCLUSIONS: In patients with asymptomatic and mild COVID-19, AYUSH-64, as add-on to standard conventional care, contributed to improved clinical recovery and demonstrated potential in reducing the levels of pro-inflammatory markers such as IL-6 and TNF-α. Further, both the groups demonstrated comparable efficacy regarding negative RT-PCR for COVID-19.