|
 
 |
| ORIGINAL ARTICLE |
|
| Year : 2022 | Volume
: 6
| Issue : 4 | Page : 160-168 |
|
Efficacy of Ayurveda intervention “Ayuraksha Kit” on COVID-19 incidence and outcomes: A prospective cluster randomized community-based study in India
Sunita Mata1, Kishor Gavali2, Sarada Ota3, Richa Singhal1, Arunabh Tripathi1, Seema Jain3, Deepa Makhija1, Parvathy G Nair4, Pratibha P Nair4, PS Aswani4, Susmita Priyadarshinee Otta5, Kshirod Kumar Ratha5, Dipsunder Sahu6, Debajyoti Das6, Harbans Singh7, Avvaru Jai Venkata Sai Prasad7, Alok Kumar Shrivastava8, Pallavi Namdev Kamble8, Laxman Bhurke9, Saylee Hemant Deshmukh10, Shashikant Vedi2, Swati Sharma1, Deepa Sharma11, Neelam Kumari Singh12, Savita Poshatti Gopod13, Chagamreddy Murali Krishna13, Govind Reddy9, Sangeeta Sangvikar7, Vanmala Wakode14, Emy S Surendram15, TP Sinimol15, Kuldeep Singh Kumar3, Vimal Tewari16, PL Bharti17, Girindra Kumar Bora17, Shri Prakash18, Rahul Dhanraji Ghuse18, Gopesh Kumar19, Poonam Mohod19, Vineeta Negi20, Chris Antony20, Sumed Narayanrao Paikrao21, Anil Avhad21, Rinky Thakur3, MN Shubhashree22, Raghavendra Naik22, S Asha23, Kancherla Prameela Devi23, Rakesh Rana1, Bhagwan Sahai Sharma1, Shruti Khanduri1, Vinod Kumar Shahi1, Narayanam Srikanth1
1 Central Council for Research in Ayurvedic Sciences, New Delhi, India
2 M S Regional Ayurveda Research Institute (MSRARI), Jaipur, Rajasthan, India
3 Central Ayurveda Research Institute, New Delhi, India
4 Department of Kayachikitsa, VPSV Ayurveda College, Kottakkal, Kerala, India
5 Central Ayurveda Research Institute, Bhubaneswar, Odisha, India
6 Central Ayurveda Research Institute, Kolkata, West Bengal, India
7 Central Ayurveda Research Institute, Patiala, Punjab, India
8 Regional Ayurveda Research Institute, Lucknow, Uttar Pradesh, India
9 Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute, Mumbai, Maharashtra, India
10 Central Ayurveda Research Institute, Mumbai, Maharashtra, India
11 Regional Ayurveda Research Institute, Gwalior, Madhya Pradesh, India
12 Regional Ayurveda Research Institute, Jhansi, Uttar Pradesh, India
13 Regional Ayurveda Research Institute, Vijayawada, Andhra Pradesh, India
14 Regional Ayurveda Research Institute, Nagpur, Maharashtra, India
15 Regional Ayurveda Research Institute, Thiruvananthapuram, Kerala, India
16 Regional Ayurveda Research Institute, Patna, Bihar, India
17 Central Ayurveda Research Institute, Guwahati, Assam, India
18 Regional Ayurveda Research Institute, Gangtok, Sikkim, India
19 Regional Ayurveda Research Institute, Jammu, India
20 Regional Ayurveda Research Institute, Mandi, Himachal Pradesh, India
21 Regional Ayurveda Research Institute, Ahmedabad, Gujarat, India
22 Central Ayurveda Research Institute, Bengaluru, Karnataka, India
23 Dr. Achanta Lakshmipati Regional Ayurveda Research Institute, Chennai, Tamil Nadu, India
| Date of Submission | 22-Aug-2022 |
| Date of Acceptance | 04-Nov-2022 |
| Date of Web Publication | 05-Dec-2022 |
Correspondence Address:
Dr. Sarada Ota
Central Ayurveda Research Institute, New Delhi
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_127_22
BACKGROUND: Ayurvedic medicines have been used as preventative care and for managing COVID-19 in India from the early days of the pandemic. This study was conducted to evaluate the effectiveness of the Ayuraksha kit (ARK), a combination of four extensively used Ayurvedic interventions, as prophylactic care against COVID-19. OBJECTIVE: The primary objective was to observe the non-occurrence of COVID-19, and the secondary objective was to observe the changes in the general well-being and manifestation of COVID-19-like symptoms in the participants. MATERIAL AND METHODS: This was a prospective, open-label, multi-center, cluster randomized community-based study conducted from October 2020-March 2021 in India. A total of 153047 participants of either sex, aged 18 - 70 years, living in Scheduled Caste dominated areas of 18 identified states in India, were enrolled. The clusters from where at least one COVID-19 case was identified were randomized and allocated into two groups. In Group-I (n = 1,34,364), Ayuraksha Kit, which contains (Chyawanprash 6 gm once daily; Ayush Kwatha 75 ml once daily; Samshamani Vati 500 mg twice daily and Anu Taila one drop in each nostril twice daily) was administered for one month along with the standard preventive measures for COVID-19. In Group II (n = 18,683), only standard preventive measures for COVID-19 as per the existing guidelines were followed. RESULT: The proportion of participants who did not report having COVID-19 were significantly higher (98.9%)in the ARK group than in the control group (98.1%) after adjusting the history of contact with COVID-19 positive subject/contact with a person having COVID-19 symptoms. The proportion of participants with COVID-19 symptoms was slightly more in the control group. Among the COVID-19-positive cases, symptomatic cases were more in the ARK group, but the incidence of hospitalization (9.8%) was much lesser than that of the control group (12.5%). Improvements in general well-being (appetite, bowel, and sleep quality) were better in the ARK group than in the control group. The medicines in the ARK were well tolerated. CONCLUSIONS: ARK may be used for general well-being and as prophylaxis for preventing COVID-19 infection. Keywords: Anu taila, Ayurveda, Ayush Kwath, Chyawanprash, COVID-19, Samshamani Vati
How to cite this article:
Mata S, Gavali K, Ota S, Singhal R, Tripathi A, Jain S, Makhija D, Nair PG, Nair PP, Aswani P S, Otta SP, Ratha KK, Sahu D, Das D, Singh H, Sai Prasad AJ, Shrivastava AK, Kamble PN, Bhurke L, Deshmukh SH, Vedi S, Sharma S, Sharma D, Singh NK, Gopod SP, Krishna CM, Reddy G, Sangvikar S, Wakode V, Surendram ES, Sinimol T P, Kumar KS, Tewari V, Bharti P L, Bora GK, Prakash S, Ghuse RD, Kumar G, Mohod P, Negi V, Antony C, Paikrao SN, Avhad A, Thakur R, Shubhashree M N, Naik R, Asha S, Devi KP, Rana R, Sharma BS, Khanduri S, Shahi VK, Srikanth N. Efficacy of Ayurveda intervention “Ayuraksha Kit” on COVID-19 incidence and outcomes: A prospective cluster randomized community-based study in India. J Res Ayurvedic Sci 2022;6:160-8 |
How to cite this URL:
Mata S, Gavali K, Ota S, Singhal R, Tripathi A, Jain S, Makhija D, Nair PG, Nair PP, Aswani P S, Otta SP, Ratha KK, Sahu D, Das D, Singh H, Sai Prasad AJ, Shrivastava AK, Kamble PN, Bhurke L, Deshmukh SH, Vedi S, Sharma S, Sharma D, Singh NK, Gopod SP, Krishna CM, Reddy G, Sangvikar S, Wakode V, Surendram ES, Sinimol T P, Kumar KS, Tewari V, Bharti P L, Bora GK, Prakash S, Ghuse RD, Kumar G, Mohod P, Negi V, Antony C, Paikrao SN, Avhad A, Thakur R, Shubhashree M N, Naik R, Asha S, Devi KP, Rana R, Sharma BS, Khanduri S, Shahi VK, Srikanth N. Efficacy of Ayurveda intervention “Ayuraksha Kit” on COVID-19 incidence and outcomes: A prospective cluster randomized community-based study in India. J Res Ayurvedic Sci [serial online] 2022 [cited 2023 Mar 25];6:160-8. Available from: http://www.jrasccras.com/text.asp?2022/6/4/160/362652 |
Trial Registration: CTRI/2020/08/027316
| Introduction | |  |
The morbidity and mortality associated with COVID-19 continued to rise as SARS-CoV-2 variants of concern became increasingly widespread despite rigorous global efforts. COVID-19, caused by Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), resulted in more than 600 million confirmed cases and more than six million deaths globally by October 2022.[1] A few interventions have shown potential to reduce the burden of morbidity and mortality from COVID-19. Moreover, very little evidence is available for the interventions that may prevent COVID-19, reduce the need for hospitalization, and prevent progression to the critical stage of the disease and death, except for COVID-19 vaccines. Currently, several approved vaccines are available for COVID-19; however, their long-term efficacy against COVID-19 is yet to be established. The high incidence of COVID-19 in countries with high vaccine coverage is another concern that might be due to dropping neutralizing antibody levels.[2]
Few studies have also reported that the vaccine’s effectiveness fell considerably after six months, particularly in older people.[3],[4] Also, individuals who have not been fully vaccinated or are not expected to develop an adequate immune response to COVID-19 vaccines (due to immune-compromised disease conditions or taking immunosuppressive medications, any contraindications for vaccine administration), and potentially reduced effectiveness of COVID-19 vaccines against the new variants of concern, highlight the need for effective prophylactic interventions against COVID-19 in the current scenario.[5],[6] The pre-exposure and post-exposure prophylaxis interventions are found to be effective for some diseases such as Hepatitis B and HIV.[7] The prophylactic interventions, if effective, could significantly impact the incidence of COVID-19 and its management by reducing the severity of the disease in high-risk populations. It may be critical, particularly among LMIC (Low and Low Middle-income Countries) populations, because it could take a long time to cover the population by vaccination. The existing interventions with an established safety profile through a long history of use may be identified for their potential prophylactic property against COVID-19 to save time and infrastructure. Several research studies have been undertaken to explore the prophylactic potential of different interventions, such as anti-viral antibodies for prophylaxis against COVID-19.[8],[9] For these reasons, it may be of particular importance to explore the potential effectiveness of Ayurveda interventions against COVID-19 for settings with limited resources.
This study was conceived when no approved vaccine for COVID-19 was available in India. Further, research studies on prophylactic interventions such as Hydroxychloroquine recommended for healthcare workers by the Indian Council of Medical Research (ICMR) during that period have shown inconclusive evidence regarding its efficacy against COVID-19.[10] So, it was required to explore a safe, cost-effective, accessible and potent option for prophylaxis against COVID-19. This study aimed to assess the prophylactic efficacy of the Ayuraksha kit in people at a higher risk of COVID-19 and in people with COVID-19-related symptoms. The Ayuraksha Kit (ARK) consisted of four Ayurveda interventions recommended by the Ministry of Ayush(MoA)for COVID-19 prophylaxis.[11] Further, preliminary research studies evaluating the efficacy and safety of these individual interventions have already been undertaken in high-risk populations either residing in containment zones or frontline workers and showed promising outcomes. This study was intended for a community-based setting to validate the findings of the above-mentioned preliminary studies and generate reliable public data.
| Materials and Methods | | |
Trial Design
This study was a prospective community-based open-label cluster randomized controlled trial.
Participants
Eligibility criteria
Healthy individuals of either sex, aged between 18–70 years, residing in the identified Scheduled Caste-dominated area/colony/village, and willing to provide written informed consent were recruited in the study.
Laboratory-confirmed cases of COVID-19 were not included in the study. Pregnant/ women planning for pregnancy and lactating women, individuals having any co-morbidities at the time of screening, those with the immune-compromised state as in HIV, hepatitis, tuberculosis, and malignancy, and taking corticosteroids or any immunosuppressive therapy were not considered for enrolment. Individuals participating in any other clinical study or any other study one month before the screening and history of hypersensitivity to the study interventions were also excluded.
Withdrawal criteria
The participants were free to discontinue the study at any point in time without assigning any reason. Participants who tested positive for COVID-19, had major symptoms that necessitated hospitalization, developed any AE/ADR or breached the study protocol were excluded from the study. Participants were also excluded if their drug compliance was <70% of the proportion of days covered (PDC).
Study setting
The study was conducted under the Ayurveda Mobile Health Care Programme of the Scheduled Caste Sub Plan (AMHCP- SCSP) of the Government of India. It was executed through 20 research institutes under the CCRAS, Ministry of Ayush, Government of India, located in 18 states across India. Since this study was conducted under the Scheduled Caste Sub Plan program, scheduled caste (SC) dominant areas/villages within the vicinity (within 5 km) of the study institutes, with at least one confirmed COVID-19 subject, were identified as clusters. The study was conducted from October 2020-March 2021.
Interventions
Participants in the intervention group (Group I) were provided Ayuraksha Kit, and Group II (control arm) was not given any specific intervention. Both groups’ participants were asked to follow the standard preventive measures/ guidelines for COVID-19.
The ‘Ayuraksha Kit’ combines Ayurveda interventions in the Ministry of Ayush(MoA) guidelines to improve immunity and promote health. The kit includes four Ayurvedic formulations. i.Chyawanprasha- A Leha preparation (confectionery) of six grams daily in the morning on an empty stomach; ii. Ayush Kwatha{combination of 04 parts of leaves of Tulsi (Ocimum sanctum Linn.), 02 parts of Dalchini (bark of Cinnamomum zeylanicum Bryn), 02 parts of Shunthi (dried rhizome of Zingiber officinale Rosc) and 01 part of Kali Mirch (fruit of Piper nigrum Linn.}- A decoction prepared by boiling 03 gms of Kwath Churna(coarse powder) in 150 ml water and reduced to 75 ml and used orally once daily (morning after food); iii. Samshamani Vati- Two tablets (250 mg each) twice daily with water after food; iv. Anu Taila-one drops in each nostril two times daily in the morning and evening. The interventions were administered for one month.
The participants in both groups were advised to follow the standard preventive measures for COVID-19 recommended by the Ministry of Health and Family Welfare, Government of India, such as wearing a mask to cover the mouth and nose and frequently washing their hands with soap and if, soap and water are unavailable, hand sanitizer containing at least 60% alcohol was to be used. The guidelines also recommended avoiding crowded places, washing hands before touching their eyes, nose, and mouth, and covering their mouth and nose while coughing and sneezing. The participants were educated and informed of the standard preventive measures to be followed through printed IEC material.
Outcomes
The primary outcome is the non-occurrence of COVID-19 in the study population, assessed as the proportion of participants with no history of contracted COVID-19 (detected through RT-PCR assay) at follow-up on days 30 and 45.
The secondary outcome measure was the participant’s self-reported improvement in parameters of general well-being such as appetite, bowel habits, and sleep on a 100 mm Visual Analogue scale (VAS) recorded on days 15, 30, and 45. Appetite on VAS was rated as ‘no hunger’ (0 mm), ‘good hunger’ (100 mm), sleep quality was rated as ‘more restless than usual/more periods of wakefulness than usual’ (0 mm), ‘more restful than usual/fewer periods of wakefulness than usual’ (100 mm)[12] and bowel habit was rated from ‘very dissatisfied’ (0 mm) to ‘very satisfied’ (100 mm).[13]
The proportion of participants reporting the occurrence of COVID-19-like symptoms (at least one of the following symptoms: fever, cough, difficulty in breathing, myalgia, headache, sore throat, new olfactory or taste disorder, or diarrhea) documented on day 15, 30 and 45 was the secondary outcome measure. Disease severity in participants assessed in terms of symptoms, hospitalization requirement, etc., among those infected with COVID-19 during the study period, was also included as a secondary outcome measure.
Sample Size
The sample size for the study was calculated based on the assumption of lowering the COVID-19 positivity rate. At the time of conception of the study in July 2020, the national positivity rate was 8.5% (as on July 1, 2020).[14] We hypothesized that the positivity rate in the ARK group would reduce by at least 10% compared to the control group. With a power of 80% and 95% confidence interval and an allocation ratio of 10: 1, 98900 participants are needed to be enrolled in the ARK group, while in the control group, 9890 participants are required. Since this is a randomized cluster trial, considering a design effect of 1.5 and an attrition rate of 20%, the sample size for the ARK group was calculated as 178020, and for the control group, it was 17802. Rounding off the sample size to near thousands, a total of 180000 participants were estimated for enrolment in the ARK group and 18000 in the control group, making the total sample size 198000, rounded off to 200000.
However, during the study period from October 2020 to March 2021, only 1,53,047 participants fulfilling the selection criteria and provided informed consent (134364 in the ARK group and 18683 in the control group) were enrolled in the trial.
Randomization
The present study was a cluster-randomized study with a specific colony as the randomization unit. Each participating institute provided a list of 10 areas within a radius of 5 km from its premises after a feasibility survey for randomization. Out of these ten colonies, one (01) area was randomly selected, and participants willing to participate in the study from that area were enrolled in the control group. The rest of the 09 colonies formed the pool for enrolling the participants in the ARK group. It was ensured that at least 1/10th of the participants in the intervention group were enrolled from each of the 09 areas. The same strategy was followed at each participating center for randomization and allocation.
Statistical methods
For validation and filtration, the collected data was entered into MS-excel. The data were filtered based on drug compliance and other important variables that could be used in the data analysis. Further, the refined data was used for the analysis. Quantitative data were represented in Mean± SD, and number (%) was used for representing qualitative data. Unpaired t-test was used to compare the quantitative variables between groups, and within-group comparison for quantitative data was done using repeated measure ANOVA. In all the statistical analyses, the significance level was 5%.
| Results | | |
A total of 134364 participants were enrolled from the intervention clusters, with a screen failure of 7184 participants due to non-fulfilling eligibility criteria. In comparison, 19480 participants were screened from the control clusters, and 18683 eligible participants were enrolled in the trial arm. The flow of the participants in the study is presented in [Figure 1]. Data from 152,296 participants were analyzed (133782 in the intervention arm and 18514 in the control arm). A total of 751 participants dropped out (due to the pregnancy of two women, and the rest were lost to follow-up) from the study.
Baseline data of study participants
There is no difference in the mean age of the participants (ARK group - 38.4 ± 13.47 years; control group - 38.2 ± 14.12 years). The proportion of male and female participants in both groups was nearly equivalent. The number of female participants in both groups was slightly higher than that of male participants. The percentage of participants having co-morbidities was balanced among both groups. It is also observed that the risk factors for contracting COVID-19 were slightly higher in the ARK group. It was also observed that a small proportion of participants were using prophylactic measures in the control group [Table 1].
Outcomes
The [Table 2] shows that the proportion of participants showing symptoms of COVID-19-compatible illness was less in the intervention group, despite the proportion of participants who underwent COVID-19 testing being slightly more than that of the control group. Among the participants tested for COVID-19, the positivity rate in the ARK group (1.12%) was less than the control group (1.89%). Though among the COVID-positive cases, symptomatic cases were more in the ARK group, only 9.8% required hospitalization compared to the control group (12.5%).
Effect of ARK on general well-being
Appetite, bowel habits, and sleep quality were assessed using VAS to rate the parameters of general well-being. [Table 3].
As per the [Table 3], appetite, sleep quality, and bowel habits improved significantly (P < 0.001) in the ARK group compared to the control group.
Incidence of adverse events
The incidence of adverse events was assessed at each follow-up. The details are depicted in [Table 4].
Out of 133782 participants, 1583 (0.011%) incidences of AE were reported. Nausea, vomiting, flatulence, constipation, and acidity/gastritis were the AE reported, which were mild, self-limiting, and relieved without any treatment.
| Discussion | | |
The purpose of this study was to collect empirical data on the effectiveness of selected interventions on general well-being and preventing COVID-19 in apparently healthy participants.
The result of the study shows that the proportion of participants with symptoms of COVID-19-compatible illness was less in the intervention group compared to the baseline. Among the participants tested for COVID-19, the positivity rate is lower in the ARK group (1.12%) than in the control group (1.89%). Likewise, the proportion of participants who required hospitalization in the study arm was also less than that of the control arm. The parameters of well-being were also observed to be better in the ARK group.
Anu Taila was administered in the trial for nasal instillation in the form of Pratimarsha Nasya. Pratimarsha Nasya is safe to use daily to prevent head, neck, and mouth diseases and respiratory disorders.[15],[16],[17] This procedure cleans, purifies, and strengthens the nasal passage, acting as a “physiological mask” that may prevent virus entry into the moist nasal or oral mucosa.[18] Ingredients of Anu taila shown to have anti-inflammatory properties and reduce pro-inflammatory cytokines such as IL-1β, TNF-α, IFN-γ, IP-10, MCP-1, IL-4, and IL-8.[19] The SARS-CoV-2 virus, which enters the upper respiratory tract via respiratory aerosols, binds to the nasal epithelial cells in the upper respiratory tract. The primary host receptor for viral entry into cells is the ACE-2, which is highly expressed in adult nasal epithelial cells. The virus undergoes local replication and propagation, along with the infection of ciliated cells in the conducting airways.[20]Anu Taila is indicated to improve the health of sense organs (Indriyas), such as the nose.[21] As a result, Anu Taila may aid in preventing COVID-19 and halting symptoms.
Chywanprash is considered Rasayana (excellent rejuvenator) and is mainly used for Kasa (cough) and Shwasa (asthma). It is also helpful in managing Kshina (emaciation) and Urakshata (injury to mediastinum) and is indicated as a rejuvenator for all age groups.[22] It has also been clinically and experimentally proven to enhance immunity and anti-inflammatory properties and is clinically safe and well tolerated.[23],[24],[25] Because of its inherent properties, the use of Chyawanprash is expected to maintain the health and well-being of individuals during COVID-19 and also aid in maintaining a healthy respiratory function.
Samshamani Vati is prepared from the aqueous extract of Guduchi (Tinospora cordifolia Willd. Miers ex Hook.f.andThoms). Guduchi is used in Jwara (fever), Kasa (cough), and also Vishaghna (anti-toxic), and Bhootaghna(antimicrobial) properties.[26] It also has anti-inflammatory, immunomodulatory, antioxidant, and anti-allergic activity, which would aid in the prevention of infectious diseases, including COVID-19.[27],[28],[29]
Ayush Kwatha is a combination of Tulsi (Ocimum sanctum Linn.), Dalchini (bark of Cinnamomum zeylanicum Bryn), Shunthi (dried rhizome of Zingiber officinale Rosc), and Kali Mirch (fruit of Piper nigrum Linn.). The ingredients of Ayush Kwatha are Katu and Tikta Rasa, with Usna Virya, and possess Deepan-Pachana, and Yakrit-uttejaka properties which improve Agni and help in Srotosodhana (improves microcirculation); thus promoting digestion, metabolism, and absorption. Ingredients of Ayush Kwatha have immune-modulatory, anti-viral, antioxidant, antipyretic, anti-inflammatory, hepato-protective, and reno-protective effects. Sunthi inhibits pro-inflammatory cytokines, whereas Marich lowers the formation of inflammatory cells, thus enabling a balance in cytokine production.[30] In a nutshell, ARK components prevent virus entry and proliferation at the mucosal level.
In the ARK group, even though the risk factors for contracting COVID-19 were slightly higher than the control group at the baseline, the COVID-19 positivity rate was reportedly low in the participants who underwent testing for COVID-19. In the intervention group, only 0.011% of participants experienced any AE/ADR, which is significantly less and indicates that the trial interventions were well tolerated. None of the participants who developed AE required treatment, and the incidences were self-limiting. None of the participants were withdrawn/dropped out from the study due to AE.
The AE/ADR might be due to the ingredients in the Ayush Kwatha, which have Ushna and Tikshna properties, which might not be suitable for individuals with Pitta Prakriti or those with gastric symptoms. The choice of medicines, their dose, dosage form, and duration in Ayurveda is based on the individual’s Prakriti, Kaala (time of medicine intake), Jatharagni (digestive power), Vaya (age), Bala (person’s strength), Dosha (body humor involvement), and Desha (geographical location).[31] These factors could not be adequately addressed because this was a community study with large sample size.
Limitations of the study
The recruitment of the target sample could not be achieved within the study period. The follow-up of the participants was conducted telephonically to avoid frequent social contact, adhering to the government guidelines, which resulted in difficulties in filling in data through telephonic interviews due to connectivity issues. A physical follow-up would have generated quality data. The study’s objective was to assess the efficacy of the trial intervention in preventing COVID-19. However, since the study was conducted in a limited resource setting and due to logistic issues associated with testing such a large sample of healthy participants at COVID-19 laboratory facilities, when the testing facilities were overwhelmed in providing service during the pandemic, mandatory testing of trial participants was not incorporated in the study. Due to feasibility issues associated with the execution of the study during the lockdown phase of the pandemic, a long-term follow-up could not be planned in the study.
Generalizability
The study was conducted in a community setup with a large sample size, so the study’s outcome is generalizable in the context of the Indian population.
| Conclusions | | |
Compared to the control group, ARK has demonstrated a slightly better effect for COVID-19 prophylaxis in terms of the occurrence of COVID-19 or COVID-19-related symptoms. It is capable of improving the overall well-being of the study participants. As only a few participants experienced minor gastrointestinal symptoms in the ARK group, it’s worth noting that ARK is clinically safe and well tolerated.
Acknowledgement
The authors would like to express their gratitude to all of the study participants for their assistance throughout the study, without which the study would not have been able to be completed successfully. The authors would also like to express their heartfelt appreciation to Dr. B.C.S Rao, Dr. Sophia J., and Dr. Amit Kumar Rai for their support during the designing of the protocol and drafting of the manuscript. The authors are also thankful to the Director General, CCRAS, New Delhi, for providing all the necessary assistance in carrying out the study. The authors would also like to thank the Managing Director, IMPCL, for providing the study drugs on time, as well as the village/area representatives and officials for granting permission and providing the infrastructure for the study.
Financial support and sponsorship
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Govt. of India.
Conflicts of interest
Authors have no conflicts of interest.
| References | | |
| 1. | World Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard. Available from: https://covid19.who.int/ [Last accessed 19 Oct 2022].  |
| 2. | Taylor L Why scientists worldwide are watching UK COVID infections. Nature 2021;599:189-90. |
| 3. | Lacy J, Tessier E, Andrews N, White J, Ramsay M, Edelstein M Impact of an accelerated measles-mumps-rubella (MMR) vaccine schedule on vaccine coverage: an ecological study among london children, 2012-2018. Vaccine 2022;40:444-9. |
| 4. | Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Freedman L, Kalkstein N, et al. Protection of BNT162B2 vaccine booster against covid-19 in israel. N Engl J Med 2021;385: 1393-400. |
| 5. | Centers for Disease Control and Prevention. SARS-CoV-2 Variant Classifications and Definitions. Updated December 1, 2021. Available from: https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-classifications.html [Last accessed 12 Jan 2022]. |
| 6. | National Institute of Health. Prevention of SARS-CoV-2 Infection. Last Updated: December 16, 2021. Available from: https://www.covid19treatmentguidelines.nih.gov/overview/prevention-of-sars-cov-2/ [Last accessed on 12 Jan 2022]. |
| 7. | Krakower DS, Jain S, Mayer KH Antiretrovirals for primary HIV prevention: the current status of pre- and post-exposure prophylaxis. Curr HIV/AIDS Rep 2015;12:127-38. |
| 8. | Cohen MS, Nirula A, Mulligan MJ, Novak RM, Marovich M, Yen C, et al; BLAZE-2 Investigators. Effect of bamlanivimab vs placebo on incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities: A randomized clinical trial. JAMA 2021;326:46-55. |
| 9. | O’Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, et al; Covid-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV antibody combination to prevent covid-19. N Engl J Med 2021;385:1184-95. |
| 10. | Indian Council of Medical Research. Revised advisory on the use of hydroxychloroquine (HCQ) as prophylaxis for SARS-CoV-2 infection (in supersession of previous advisory dated 23rd March, 2020), Available from: https://www.icmr.gov.in/pdf/covid/techdoc/V5_Revised_advisory_on_the_use_of_HCQ_SARS_CoV2_infection.pdf. [Last accessed on 19 Oct 2022] |
| 11. | Ministry of Ayush, Government of India. National Clinical Management Protocol based on Ayurveda and Yoga for management of Covid-19. Available from: https://www.ayush.gov.in/docs/ayush-Protocol-covid-19.pdf [Last accessed on 12 Jan 2022]. |
| 12. | Santhi N, Ramsey D, Phillipson G, Hull D, Revell VL, Dijk, DJ Efficacy of a topical aromatic rub (Vicks VapoRub®) on effects on self-reported and actigraphically assessed aspects of sleep in common cold patients. Open Journal of Respiratory Diseases 2017;7:83-101. https://doi.org/10.4236/ojrd.2017.72009 |
| 13. | Hudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, et al. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. Journal of Patient-Reported Outcomes 2019;3:64. |
| 14. | Abella BS, Jolkovsky EL, Biney BT, Uspal JE, Hyman MC, Frank I, et al; Prevention and Treatment of COVID-19 With Hydroxychloroquine (PATCH) Investigators. Ef ficacy and safety of hydroxychloroquine vs placebo for pre-exposure SARS-cov-2 prophylaxis among health care workers: A randomized clinical trial. JAMA Intern Med 2021;181:195-202. |
| 15. | Ministry of Ayush, Government of India. https://main.ayush.gov.in/event/ayurveda-preventive-measures-self-care-during-covid-19-pandemic. [Last Accessed on 27 Apr 2020]. |
| 16. | Central Council for Research in Ayurvedic Sciences. http://www.ccras.nic.in/content/pratimarsha-nasya [Last Accessed on 6 Jul 2020] |
| 17. | Murthy KRS Vagbhata’s Ashtang Hridya, Vol. I, SutraSthana, Chapter 20, Verse 32. 1st ed. Varanasi: Krishnadas Academy; 1991. p. 261 |
| 18. | Parasher A COVID-19: current understanding of its pathophysiology, clinical presentation and treatment. Postgrad Med J 2021;97:312-20. |
| 19. | Balkrishna A, Bhatt AB, Singh P, Haldar S, Varshney A Comparative retrospective open-label study of ayurvedic medicines and their combination with allopathic drugs on asymptomatic and mildly-symptomatic COVID-19 patients. J Herb Med 2021;29:100472. |
| 20. | Sharma RK Agnivesha’s Caraka Samhita, based on Chakrapani Datta’s Ayurveda Dipika by Vol III, Chikits Asthana Chap. I-XIV, Verse 62–74. Reprint ed. Varanasi: Chaukhamba Sanskrit Series office; 2010. p. 20 |
| 21. | Bridges JP, Vladar EK, Huang H, Mason RJ Respiratory epithelial cell responses to SARS-CoV-2 in COVID-19. Thorax 2022;77:203-9. doi:10.1136/thoraxjnl-2021–217561. |
| 22. | Bode M Assembling cyavanaprāsh, ayurveda’s best-selling medicine. Anthropol Med 2015;22:23-33. |
| 23. | Narayana DB, Durg S, Manohar PR, Mahapatra A, Aramya AR Chyawanprash: A review of therapeutic benefits as in authoritative texts and documented clinical literature. J Ethnopharmacol 2017;197:52-60. |
| 24. | Gupta A, Kumar S, Dole S, Deshpande S, Deshpande V, Singh S, et al. Evaluation of cyavanaprāśa on health and immunity related parameters in healthy children: A two arm, randomized, open labeled, prospective, multicenter, clinical study. Anc Sci Life 2017;36:141-50. |
| 25. | Sastry JLN Dravyaguna Jijnana (Study of the essential Medicinal Plants in Ayurveda, Vol.II. 2nd ed. Varanasi: Chaukhambha Orientalia;2005. p. 33-49. |
| 26. | Adluri USP, Tripathi AC Understanding COVID - 19 pandemic - A comprehensive Ayurvedic perspective [published online ahead of print, 2020 September 8]. J Ayurveda Integr Med 2020;S0975-9476:30064-4. doi:10.1016/j.jaim.2020.08.001 |
| 27. | Upadhyay AK, Kumar K, Kumar A, Mishra HS Tinospora cordifolia (willd.) Hook. F. And thoms. (guduchi) - validation of the ayurvedic pharmacology through experimental and clinical studies. Int J Ayurveda Res 2010;1:112-21. |
| 28. | Tiwari P, Nayak P, Prusty SK, Sahu PK Phytochemistry and Pharmacology of Tinospora cordifolia: A Review. Free Radicals and Antioxidants 2018;9:70-8. |
| 29. | Antul K, Amandeep P, Gurwinder S, Anuj, C Review on Pharmacological Profile of Medicinal Vine: Tinospora cordifolia. Current Journal of Applied Science and Technology 2019;35:1-11. https://doi.org/10.9734/cjast/2019/v35i530196 |
| 30. | Gautam S, Gautam A, Chhetri S, Bhattarai U Immunity Against COVID-19: Potential Role of Ayush Kwath [published online ahead of print, 2020 Aug 17]. J Ayurveda Integr Med 2022;13:100350. |
| 31. | Murthy S Sharngadhar Samhita Prathama Khanda. Ch. 1. Ver. 37–38. Reprint Ed. Varanasi: Chaukhambha Orientalia; 2012. p. 7. |
[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4]
|
Search Pubmed for