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Background Bronchial asthma (BA) is a significant health problem and harms the quality of life, and better healthcare strategies are still needed for BA. Therefore, the scope of complementary and traditional medicine therapies on this concern must be explored. Thus the present study aimed to determine the efficacy and the safety of Kantakaryavaleha and Eladi Gutika in mild, stable bronchial asthma Method This prospective, open-label, multicenter clinical feasibility trial executed at two different OPD under Central Council for Research in Ayurvedic Sciences (CCRAS). In this study, 83 diagnosed cases of mild stable BA, 18–60 years age, were evaluated to assess the efficacy and safety of Kantakaryavaleha and Eladi Gutika. Eladi Gutika 1 gm thrice daily and Kantakaryavaleha 20 ml twice daily with an equal quantity of water were administered for 84 days. Primary outcome measures were done by changes in Asthma Control Questionnaire (ACQ) scores and frequency of need for control medication. The secondary outcome measures were assessed by changes in FEV1, serum CRP, serum IgE, frequency of need for rescue medication, and any adverse events. Results Significant (p viz. paroxysm of breathlessness, wheezing, cough, expectoration of sputum, tightness in the chest, skin allergy, worsening of breathlessness at night, awakening in the night. In Asthma Control Questionnaire (ACQ) score and FEV1 parameters also, significant (p Kantakaryavaleha and Eladi Gutika are effective and safe in managing mild, stable bronchial asthma. A multicentric, double-blind, randomized controlled trial (RCT) may be planned with a more extended follow-up period to aid in the present findings. Trial registration: The clinical trial has been registered in the Clinical Trial Registry of India (CTRI/2018/06/014425) /http://ctri.nic.in.

In this study a model is conceptualized to measure the child mortality under different parity of women such that a better strategy can be formulated to bring down mortality rates. In the estimation of probability of child mortality some socio demographic variables are taken in consideration. The estimates are obtained under Bayesian procedure. Two different models are formulated for it and model fitting is observed by graphical approach along with the chi square test. First model is betabinomial and second is binomial regression model. Second model shows the better fit on the data. The estimate of probability of child mortality at higher parities namely, parity 3, parity 4 and parity 5 were obtained as 0.06, 0.09 and 0.13 respectively on the basis of the second model.

UNSTRUCTURED This is the authors' response to peer reviews.

Background: Outbreak of SARS-CoV-2 is Janapadoddhwamsa Vikara (epidemic disease) in Ayurveda, where Rasayana drugs (immunomodulators or rejuvenating therapy) have been advocated for controlling the diseases. Therefore, Guduchi Ghan Vati, containing a drug Guduchi (Tinospora cordifolia), a plant is selected for prevention of COVID-19. Objectives: To know the efficacy and safety of Ayurvedic intervention i.e. Guduchi Ghan Vati in prevention of COVID-19 infection among the community of containment areas. Methods: It is an open label, prospective, non-randomized, community based interventional study, carried out from 06 May to 23 June, 2020, in a containment zone Bijhari area of District Hamirpur of Himachal Pradesh, India. Guduchi Ghan Vati was provided to the community in dose of 500 mg twice a day with luke warm water on empty stomach for 30 days. Their demographic and health related data and Follow up of the same subjects was done on the 30th day through telephonic interviews using the E-format (google forms). Results: Total 1165 participants’ data were analysed to assess the efficacy and safety of Guduchi Ghan Vati. In the sample 85.2 % participants had no systemic disorders whereas 13.8 % participants were taking concomitant medicines for other morbidities. Incidence of COVID-19 positive cases was only 0.1% (n=01). Conclusion: Ayurvedic intervention (Guduchi Ghan Vati) was found to be safe and effective as a prophylactic measure for COVID-19 infection. This intervention was helpful in improving physical and psychological well-being with minimal adverse drug Reaction/Adverse Effect.

AYUSH Sanjivani is a mobile application launched by the Ministry of AYUSH (MoA) to gather information regarding the utilization of AYUSH (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) advocacies for the prevention of COVID-19 infection. A cross-sectional analysis of the data generated through this mobile application has been performed and presented in this article to examine the acceptability and extent of utilization of AYUSH preventive measures in India.Objectives: The objectives of this cross-sectional analysis was to determine the trends of the utilization of AYUSH measures by the beneficiaries as reported by AYUSH practitioners and by the practitioners themselves for the prevention of COVID-19 and to determine the benefit obtained in terms of self-reported parameters of general well being, the overall impact on general health and in preventing the onset of flu-like symptoms.Methods: A secondary data analysis was undertaken, utilizing the cross-sectional data generated through the AYUSH Sanjivani App from May to July 2020. The responses in terms of demographic profile, utilization pattern, benefits obtained, the interventions used and the data of beneficiaries in terms of geographic location and interventions prescribed were analyzed statistically to assess the trends of the utilization of AYUSH measures for prophylaxis.Results: Data of 74,568 AYUSH physicians and 1,35,21,245 beneficiaries/health seekers whose data were reported by 3623 AYUSH practitioners were used for analysis. AYUSH advocacies/measures were utilized by 69,195 (92.8%) physicians for prophylaxis. Samshamani Vati, Chyavanprash, and Arsenicum Album-30 were the most commonly used AYUSH interventions. Improvement in terms of appetite, bowel movements, sleep, mental well being, stamina, change in pre-existing disease, and change in disposition were reported by 42400 (61.3%) physicians. Maximum beneficiaries were from the state of Gujarat followed by Madhya Pradesh. Arsenicum Album-30 was the most commonly prescribed/distributed intervention among the beneficiaries/ health seekers.Conclusion: Maximum physicians have reported having benefited from the use of AYUSH prophylactic measures for the prevention of COVID-19. Moreover, a good proportion of the Indian population was provided the AYUSH prophylactic measures as recorded in the app.

Background: The evidence on the efficacy and safety of Ayurveda interventions as add-on to the standard conventional care for COVID-19 is limited. This study was planned to explore the potential of AYUSH-64 as add-on to conventional care in improving the clinical recovery and negative 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 group in 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, while the control group received only standard care. The effect of the interventions was assessed in terms of negative RT-PCR for COVID-19, clinical cure rate and inflammatory cytokines.Outcome measures: Primary outcome was the time to attain negative RT-PCR for COVID-19 and proportion of participants turned RT-PCR negative for COVID-19 at 7th, 15th, 22nd and 30th day respectively in the intervention group compared to the control group. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd, and 30thday; improvement in laboratory parameters on the 30th day (as compared to baseline) and incidence of Adverse Drug Reactions/Adverse Events (ADRs/AEs). The data was 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 rate in terms of time taken for complete cure of 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 control group respectively which is numerically a better clinical outcome in the intervention group. The improvement in the inflammatory markers such as IL-6, TNF-α and D-dimer was statistically significant in the intervention group (p

Background: Currently, there is no approved treatment for the management of COVID-19 pandemic. Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19.Objectives: To determine the clinical effectiveness and safety profile of an Ayurveda Intervention (Guduchighan Vati) in asymptomatic and mild to moderate cases of COVID-19.Methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighan Vati 500 mg twice daily for 10 days was administered in the intervention group as standalone therapy and Hydroxychloroquine in the control group.Outcome measures: Time to negative RT-PCR for COVID-19, proportion of participants turned RT-PCR negative for COVID-19 at 5th and 10th day, duration to achieve complete clinical recovery, improvement in laboratory parameters and incidence of Adverse Drug Reaction/Adverse Event. The data was compared within group using paired sample t-test/ Wilcoxon signed rank test and between group using independent sample t-test/Mann-Whitney test. The results of RT-PCR test was compared between group using chi-square test.Results: 93.3% participants turned RT-PCR negative for COVID-19 in the intervention group, as compared to 66.6% participants in control group till 10th day of the study period. However, the results are statistically insignificant (p = 0.068) which might be attributed to smaller sample size. All the symptomatic patients in the intervention group were clinically recovered at 5th day whereas 14 out of 15 recovered in the control group. No symptoms were observed at 10th day in both the groups. No adverse drug reaction/serious adverse event were observed during the study period.Conclusion: Guduchighan Vati is a safe and effective treatment for asymptomatic and mild cases of COVID-19 and it lowers the time to RT-PCR negative status without any adverse drug reaction/adverse event.

BackgroundCoronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are at high risk of exposure, the standard of care is personal protection from getting infected. Whether Ayurvedic rasayana drug like Chyawanprash can prevent symptomatic infection in frontline health care workers is unknown.ObjectiveTo evaluate the effect of the combination of Chyawanprash and Standard Preventive Regimen compared to the use of Standard Preventive Regimen alone on the proportion of RT-PCR confirmed COVID-19 infections among frontline healthcare workers (HCWs).MethodsAn open-label randomized controlled trial was conducted in the HCWs between 25 to 60 years age currently working in an environment with chance of direct exposure to COVID-19 cases. The interventions to be compared in this trial were Standard Preventive Regimen as per institutional guidelines and based on their roles (Group I) and Ayurvedic Intervention viz., Chyawanprash 12 g twice for 30 days from day of randomization plus Standard Preventive Regimen (Group II). The incidence of RT PCR confirmed COVID-19 cases in both groups, was the primary outcome measure. Evaluation of the safety of the study drug (by any statistically significant change in various biochemical and hematological parameters and occurrence of any adverse drug reactions); incidence of any other infective diseases (bacterial /viral/ fungal / etc.) like upper respiratory tract illness during the study period and any change in the immunoglobulins like IgG, IgM and IgE and inflammatory markers like TNF alpha, IL-6 and IL-10 were the secondary outcome measures.ResultsOut of 193 participants who completed the study, no participant in both groups was COVID-19 positive at the end of one month. In post intervention follow-up, 4 subjects in Group I and 2 subjects in Group II were COVID-19 positive. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters was observed before and after the study. Statistically significant rise in Serum IgG level was seen in Group II but other inflammatory and immune markers did not show statistically significant difference.ConclusionChyawanprash was well tolerated by all the participants in the intervention group but to prove its adaptogenic effect and efficacy as an add-on to the standard care in preventing the occurrence of COVID-19, clinical trial for longer duration with larger sample size is needed.Trial registrationClinical Trials Registry of India vide CTRI/2020/05/025275 dated 20/05/2020Date of IEC approval19.5.2020

After declaration of Covid – 19 as pandemic by WHO, countries adopted several measures to contain the spread as well as test and treat the patients. Further, as no effective management protocols to address this pandemic were available, a need was felt to explore the integration of modern and traditional medicines to treat Covid 19 cases. In view of this an exploratory nonrandomized prospective study has been undertaken for comparing the outcomes of traditional Ayurvedic classical formulation of Tinospora cordifolia (Guduchi) and Piper longum (Pippali) as an add on to standard of care (SOC) using modern medicine with SOC alone. This has been done in mild and moderate Covid – 19 cases, at a tertiary care integrative Medicine hospital in the National Capital Region, Gurgaon, India. The outcomes have been evaluated in terms of the duration of hospital stay, the time to clinical recovery, safety and non-interference/interaction of Ayurvedic and Further, long term impact of Covid – 19 treatment has been evaluated using quality of life questionnaire after 3 months of discharge. Findings of present study reveals that the Ayurveda add-on formulation of Tinospora cordifolia (Guduchi) and Piper longum (Pippali) has reduced the length of hospital stay and improve the recovery time. General feeling of wellbeing and activity levels were better in the 3 month follow-up post discharge in the Ayurveda add-on group. It is suggested that this formulation needs further investigated to provide more information on effective and safe herbal add-on to SOC for better outcomes to treatment of COVID-19 disease.

Currently, there is no approved treatment for the management of coronavirus disease (COVID-19). Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19.To determine the clinical efficacy and safety of an Ayurveda intervention (This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19.The proportion of participants with negative RT-PCR for COVID-19 in theIn this study on asymptomatic and mild to moderate cases of COVID-19

Background: After declaration of COVID- 19 as pandemic by WHO, countries adopted several measures to contain the spread as well as test and treat the patients. Further, as no effective management protocols to address this pandemic were available, a need was felt to explore the integration of modern and traditional medicines to treat COVID- 19 cases. Objective: To undertake a study with Ayurveda formulation as add on to existing standard of care (SOC) and to compare the outcomes in terms of patient acceptability, the time to clinical recovery, hospital stay as well as any signs of drug-herb interaction between the Ayurveda formulation and the SOC. Material and methods: An exploratory nonrandomized prospective study has been undertaken for comparing the outcomes of traditional Ayurvedic classical formulation of Tinospora cordifolia (Guduchi) and Piper longum (Pippali) as an add on to standard of care (SOC) using modern medicine with SOC alone. This has been done in mild and moderate COVID- 19 cases, at a tertiary care integrative Medicine hospital in the National Capital Region, Gurgaon, India. The outcomes have been evaluated in terms of the duration of hospital stay, the time to clinical recovery, safety and non- interference/interaction of Ayurvedic and Further, long term impact of COVID- 19 treatment has been evaluated using quality of life questionnaire after 3 months of discharge. Results: Findings of present study reveals that the Ayurveda add-on formulation of T. cordifolia (Guduchi) and P. longum (Pippali) has reduced the length of hospital stay and improve the recovery time. General feeling of wellbeing and activity levels were better in the 3 month follow-up post discharge in the Ayurveda add-on group. Conclusion: Addition of Ayurveda formulation has reduced the time of recovery and duration of hospital stay. However, this formulation needs further investigated to provide more information on effective and safe herbal add-on to SOC for better outcomes to treatment of COVID-19 disease.

Survival studies mainly deal with distribution of time to event. Often in such studies researchers are interested in comparing several treatment or prognostic groups. At the time of analysis, there is an unmeasured chance of making type I error, or finding a falsely significant difference between any two groups. The chance of making type I error is increased, if multiple groups are compared simultaneously. In this paper, survival analysis with Bonferroni correction is explained in easy way to cope up with this issue. The DLHS-3 data are taken to explain this methodology in the context of neonatal survival. Kaplan-meier plot with three survival comparison test is used to elaborate the application of Bonferroni correction.

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.

Background: The initiation of tobacco addiction is complex, and several factors contribute to the onset of this behavior. It is presumed that the influence of family environment may pose a key factor in tobacco addiction. Tobacco-use has been highly observed in the Jamnagar district of Saurashtra region of Gujarat, India. No earlier study has focused on determining the pervasiveness of tobacco-use in families of tobacco users and non-users in this geographical area. Thus, this study aimed to assess the practice and pattern of tobacco-use (smoking and/or tobacco-chewing) in the families of tobacco-user patients. Methods: We studied the families of 65 tobacco-user patients (Group 1) who visited an outpatient clinic of an Ayurvedic post-graduate hospital with complaints of cough were studied and compared with age and gender-matched non-tobacco users (Group 2). The prevalence of tobacco use among the parents, siblings, and children of both groups was analyzed and compared. Results: The findings revealed that tobacco use among parents, siblings, and children in Group 1 was higher than Group 2 (p &lt, 0.001). This meant that the problems of tobacco addiction are not always related to the individual, and therefore, tobacco-prevention strategies should focus on the entire family. Conclusions: These findings offer further insight into the promotion of smoking prevention interventions. Nevertheless, further research is warranted.

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.