|Year : 2021 | Volume
| Issue : 1 | Page : 13-25
A randomized controlled trial to evaluate the prophylactic efficacy of Chyawanprash in healthcare workers during the COVID-19 pandemic
Arun Gupta1, Amit Madan2, Babita Yadav3, Pallavi Mundada3, Richa Singhal3, Arunabh Tripathi3, Bhogavalli C Rao3, Bharti Gupta2, Rakesh Rana3, Bhagwan Sharma3, Yogesh Pandey4, Riju Agarwal5, Narayanam Srikanth3, Kartar Singh Dhiman3
1 Department of Panchakarma, Ch. Brahmapraksh Ayurveda Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India
2 Central Ayurveda Research Institute, CCRAS, Punjabi Bagh, New Delhi, India
3 Central Council for Research in Ayurvedic Sciences, Janakpuri, New Delhi, India
4 Department of Kayachikitsa, Ch. Brahmapraksh Ayurveda Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India
5 Department of Shalakya Tantra, Ch. Brahmapraksh Ayurveda Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India
|Date of Submission||18-Aug-2021|
|Date of Acceptance||18-Sep-2021|
|Date of Web Publication||14-Dec-2021|
Central Council for Research in Ayurvedic Sciences, Room No. 013, CCRAS Headquarters, 61−65, Institutional Area, ‘D’ Block, Janakpuri 110058, New Delhi.
Source of Support: None, Conflict of Interest: None
INTRODUCTION: Healthcare workers (HCWs) are high-risk individuals in the management of epidemics caused by highly contagious disorders such as coronavirus disease 2019 (COVID-19). Standard of care (SOC) for the prevention of exposure can be greatly supported with SOC measures to improve the immune response. The purpose of this study was to evaluate the effect of combining Chyawanprash, an Ayurvedic formulation, with SOC for prevention versus SOC alone among frontline HCWs through assessment of the proportion of COVID-19 cases among the trial participants during the trial period. METHODS: This open-label, randomized controlled trial was conducted from June 13, 2020 to September 21, 2020 in an Ayurvedic hospital that was functioning as a COVID-19 care center in New Delhi during the pandemic. HCWs between 25 and 60 years of age working in an environment with the possibility of direct exposure to COVID-19 cases were enrolled and observed for 30 days. The interventions compared were SOC as per institutional guidelines and based on their roles (Group I) and SOC in addition to Chyawanprash 12 g twice a day for 30 days (Group II). RESULTS: Out of the 193 participants who completed the study, no participant in both groups was COVID-19 positive at the end of one month. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters were observed. A statistically significant rise in serum IgG level was seen in Group II, but other inflammatory and immune markers did not show any statistically significant difference. In the post-intervention follow-up, four subjects in Group I and two subjects in Group II reported to have developed COVID-19 disease after 2 months of completion of the study period. CONCLUSIONS: Chyawanprash has an immunomodulatory effect in the intervention group, but a longer-term clinical trial with a bigger sample size is needed to confirm its adaptogenic and preventive efficacy as an add-on to standard prophylactic guidelines for prevention of disease. TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2020/05/025275 [Registered on: 20/05/2020].
Keywords: Adaptogen, Chyawanprash, health personnel, prophylaxis, Rasayana, SARS CoV-2
|How to cite this article:|
Gupta A, Madan A, Yadav B, Mundada P, Singhal R, Tripathi A, Rao BC, Gupta B, Rana R, Sharma B, Pandey Y, Agarwal R, Srikanth N, Dhiman KS. A randomized controlled trial to evaluate the prophylactic efficacy of Chyawanprash in healthcare workers during the COVID-19 pandemic. J Res Ayurvedic Sci 2021;5:13-25
|How to cite this URL:|
Gupta A, Madan A, Yadav B, Mundada P, Singhal R, Tripathi A, Rao BC, Gupta B, Rana R, Sharma B, Pandey Y, Agarwal R, Srikanth N, Dhiman KS. A randomized controlled trial to evaluate the prophylactic efficacy of Chyawanprash in healthcare workers during the COVID-19 pandemic. J Res Ayurvedic Sci [serial online] 2021 [cited 2022 Nov 26];5:13-25. Available from: http://www.jrasccras.com/text.asp?2021/5/1/13/332446
| Key Summary Points|| |
Whether Ayurvedic formulations such as Chyawanprash (Rasayana medicine) when given along with the standard preventive measures can protect the HCWs better than the use of standard of care alone was not known. So this study was conducted to explore the same.
The study revealed that Chyawanprash was well tolerated by the participants and the trial group was better protected even after 2 months of the post-intervention period.
Serum IgG level at the end of the study period was higher in group II compared to group I but to prove the adaptogenic effect and prophylactic efficacy of Chywanprash as an add-on to the standard care against COVID-19, clinical trial for a longer duration with a larger sample size is needed.
| Introduction|| |
Healthcare workers (HCWs) play a pivotal role in the management of any public health emergency. They have been central to the coronavirus disease 2019 (COVID-19) response since the beginning of this pandemic. Many of their functions and roles put them at a high risk of exposure to hazards that can impact their physical and mental well-being. HCWs continue to encounter a slew of linked variables affecting their health and stress levels as a result of their working environment. This impact increases with irregular working hours, higher levels of exposure to illness, fear of infection of COVID-19 due to exposure, and/or lack of adequate personal protective equipment (PPE), etc. A recent study with data from six countries found that insomnia, sleeping disorders, and burnout were significant risk factors for COVID-19 infection among HCWs. A systematic review suggests that occupational risk for health workers can increase in certain clinical settings or with suboptimal hand hygiene, long working hours, or improper or suboptimal use or nonavailability of PPE.
COVID-19 is primarily transmitted from person to person through respiratory droplets. When a person infected with COVID-19 sneezes, coughs, or talks, droplets are released. Infectious droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. Respiratory droplets can land on hands, objects, or surfaces around the person when they cough or talk, and people can then become infected with COVID-19 from touching hands, objects, or surfaces with droplets followed by touching their eyes, nose, or mouth as a habit. Such transmission of COVID-19 can also occur through droplets of those with mild symptoms or those who are infected but do not feel ill, that is, asymptomatic positive cases. So, the best preventive measure advocated is avoiding contact of the droplets until an effective vaccine is administered. Transmission due to short-range inhalation of aerosols is a possibility, particularly in crowded medical wards and inadequately ventilated spaces. Therefore, strict adherence to Infection Prevention Control practices, especially appropriate use of PPE, is advised to protect the HCWs.
Although there is a high risk of exposure during health care in the isolation wards, there is always a high risk of transmission to HCWs from presymptomatic and asymptomatic patients reporting with non-COVID disease, even in non-COVID-19 hospitals, due to community transmission. Hospitalized patients with SARS-CoV-2 infection show persistent virus shedding even lasting up to 60−80 days after diagnosis. Although the COVID-19 care hospitals are equipped with specialized safety measures and PPEs, doctors who treat patients before the hospitalization stage (general practitioners or family physicians) are not protected similarly. N95 masks and gloves are the protective equipment recommended by the government for the outpatient doctors. However, HCWs who deal with patients before a confirmed diagnosis may not be adequately protected, if they only use masks and gloves. Several patients conceal the history of their exposure and triaging patients into fever and non-fever categories is also not done in small and congested clinics eventually; HCWs are at greater risk of infection in such circumstances. A news report in September 2020 revealed that more than 87,000 HCWs have been infected with COVID-19 with a 9% positivity rate, with just six states, namely Maharashtra, Karnataka, Tamil Nadu, Delhi, West Bengal, and Gujarat, accounting for three-fourths of the case burden and more than 86% of the 573 deaths among the healthcare workforce. The possible factors responsible for high infections include lax infection control in healthcare facilities and the lack of stringent containment measures in areas where HCWs reside.
Till the arrival of the vaccine for the prevention of COVID-19, numerous recommendations from the health authorities were issued as prophylactic measures. The Joint Monitoring Group and the National Task Force for COVID-19 management in India had advised the use of hydroxychloroquine (HCQ) as prophylaxis in asymptomatic health workers involved in the containment and treatment of COVID-19 as well as in non-COVID hospitals/non-COVID areas of COVID hospitals/blocks; asymptomatic frontline workers, such as surveillance workers deployed in containment zones and paramilitary/police personnel involved in COVID-19-related activities and asymptomatic household contacts of laboratory confirmed cases. HCQ was advised to be used along with proper use of PPE and other infection control practices to protect from COVID 19. The use of HCQ as prophylaxis was prohibited in cases of retinopathy, hypersensitivity to HCQ or 4-aminoquinoline compounds, G6PD deficiency, preexisting cardiomyopathy and cardiac rhythm disorders, severe renal or hepatic diseases, children younger than 15 years of age, and in pregnancy and lactation. The possibility of cardiovascular side effects such as cardiomyopathy and rhythm (heart rate) disorders, transient visual disturbance including blurring of vision are reported with the use of HCQ, leading to necessity of discontinuation of the drug and so its intake was recommended under strict medical supervision. According to Rathi et al., even a 0·1% proportion of serious complications would amount to more than 10,000 severe adverse events in New Delhi (India) alone.
In context with controlling the spread of disease, state agencies also undertook population-wide distribution of yet unproven homeopathic and Ayurvedic medicines and herbal tea mixes (ukalo), claiming that it can boost immunity and prevent quarantined individuals from getting infected. Practitioners also prescribed various other medications, including the antiparasitic drug ivermectin. However, it was not recommended in the national guidelines but was advised to be used in patients in whom HCQ is contraindicated.
In response to the COVID-19 crisis, the Ministry of Ayush, Government of India also released a set of guidelines, titled “Ayurveda’s immunity boosting measures for self care during the COVID-19 crisis,” which was available to the public (https://www.ayush.gov.in/docs/123.pdf). These guidelines listed 10 measures that were aimed at boosting immunity against infections, though without any specific claims being made with reference to COVID-19. This list consisted of an Ayurvedic classical formulation categorized as a Rasayana medicine, such as Chyawanprash.
Chyawanprash is included in the Ayurvedic Pharmacopoeia of India, and it is being prescribed by Ayurveda physicians. Since thousands of years it has been used to improve general body strength and vitality among children, adults, as well as the elderly. It is an effective adaptogenic antioxidant in normal people and cases of depression. In order to ensure HCWs' physical and mental well-being, it is critical that they receive adequate support. Although the standard of care (SOC) to prevent exposure to the virus-containing droplets is of utmost importance to avoid spread of COVID-19, there is a need to gather evidence for the effectiveness of certain interventions that could be safely coadministered to enhance immunity and build strength in the host to prevent the infection, especially in high-risk individuals. So, this study was conducted to evaluate the efficacy of Chyawanprash, as an add-on to the standard measures, in preventing COVID-19 infection in HCWs functioning at a COVID-19 care hospital in Delhi.
Objective of the study: The present study was conducted to assess the impact of Chyawanprash on the incidence of SARS-CoV-2 (COVID-19) infection among healthcare personnel exposed to COVID-19 cases.
| Methods|| |
A prospective interventional parallel-arm randomized controlled trial was conducted between June 13, 2020 and September 21, 2020 among 199 HCWs who were functional at the COVID-19 Isolation Ward in Choudhary Brahmaprakash Ayurveda Charak Sansthan’s Hospital, Khera Dabur, New Delhi, India.
The study was conducted in compliance with applicable ethical guidelines. Institutional Ethics Committee approval on the study protocol, participant information sheet, and informed consent form was obtained before the study initiation.
The study was registered with the Clinical Trial Registry of India vide CTRI/2020/05/025275 dated May 20, 2020. The CONSORT statement guidelines have been followed in reporting the outcomes of the study.
All the HCWs of either sex functional at the said study setting during the study period were screened for inclusion and exclusion criteria after obtaining informed written consent.
All HCWs between 25 and 60 years currently working in an environment with direct exposure to patients with confirmed COVID-19 infection were eligible to participate in the trial.
HCWs who declined consent, who had a confirmed COVID-19 infection, who were already taking chloroquine/HCQ for any indication or any other prophylactic drug, pregnant or breastfeeding women, having a known comorbidity or an immune-compromised state, and having a known allergy for the study drug were excluded.
Eligible participants were allocated 1:1 in either group randomly by using a computer-generated list of random numbers. This list was generated at the headquarters of the Central Council for Research in Ayurvedic Sciences, New Delhi. This was an open-label study. Assigned treatment was known to the research team and participants. Bias was supposed to be mitigated through an objective end point (laboratory-confirmed COVID-19 infection).
The randomization code was not released until the patient was recruited into the trial, that is, until all baseline measurements were completed. The sequentially numbered, opaque, sealed envelope technique was administered by the trial coordination center for allocation concealment.
The interventions to be compared in this trial were the Standard Preventive Regimen (Group I) and Ayurvedic Intervention, namely Chyawanprash 12 g twice plus Standard Preventive Regimen (Group II). Chyawanprash is a classical Ayurvedic formulation. The Standard Preventive Regimen included standard precautions such as hand hygiene, PPE (as per institutional guidelines and based on their roles), and respiratory hygiene and cough etiquette. Participants were discouraged from taking any other home remedies or other preventive measures in both groups (such as gargling with hot water, etc.) throughout the study period. In the current study, Chyawanprash manufactured by Good Manufacturing Practice (GMP) approved Ayurveda pharmacy was used.
Participants were assessed clinically at baseline, and on the 7th, 15th, and 30th day for protocol compliance and recording any adverse events if they happened. As the duration of the intervention was 30 days from the day of randomization, the lab investigations were done at the baseline and on the 30th day.
The primary outcome was assessment of the prophylactic efficacy of Chyawanprash as an add-on intervention to the standard preventive measures adopted by HCWs in a COVID care hospital. So, the primary outcome measure was the incidence of COVID-19 cases confirmed by the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test, in both the groups.
The secondary outcomes were evaluation of the safety of the study drug by comparing the biochemical and hematological parameters both before and after the study and through the occurrence of any adverse drug reactions; the assessment of the efficacy of Chyawanprash in preventing other infective diseases (bacterial, viral, fungal, etc.) such as upper respiratory tract illness through the incidence of groups of symptoms such as fever, fatigue, cough, anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, headache; and evaluation of the effect of Chyawanprash on immunoglobulins and inflammatory markers through comparing the levels of IgG, IgM, IgE, high sensitivity C-reactive protein (hsCRP), tumor necrosing factor alpha (TNF alpha), and Interleukins, namely IL-6 and IL-10. The immunoglobulins and inflammatory markers were assessed in every fifth subject in each group both before and after the study.
Sample size calculation
On the basis of assuming incidence of COVID-19 in only 40% patients in Group I (SOC) as compared with 20% in Group II (Chyawanprash as an add-on to the SOC) with 95% Confidence Level (α = 0.05), 80% power and expecting a dropout rate of 20%, the number of patients to be enrolled in the study was calculated as approximately 100 in each group. Therefore, the total sample size was 200 HCWs.
Data were collected in predesigned Case Report Forms and entered in an electronic format prepared in MS Excel. Qualitative variables are described in Number (%), whereas quantitative variables are described in mean (SD) or Median (Q1, Q3). Qualitative variables in the study have been compared by using the chi-square test. The quantitative variables are compared by repeated-measures Analysis of Variance (ANOVA)/Friedman test and paired t-test/Wilcoxon sign-rank test within groups. In-between group comparison t-test/Mann-Whitney test is used. The level of significance is taken at 5%.
| Results|| |
Out of the total 204 HCWs screened, 199 were enrolled in the study. Overall, 95 participants in the control group (Group I) and 98 in the intervention group (Group II) completed the study [Figure 1]. Four individuals in Group I dropped out because they did not want to continue, while two participants in Group II were dropped during follow-up because they were unable to attend.
Demographic and clinical characteristics
Baseline characteristics of the participants in both the groups were similar [Table 1]. In the standard care group, that is Group I, 50.5% participants were female, the mean age was 33.35 years, and mean body mass index (BMI) was 24.44 kg/m2. In Group II, in which participants were given Chyawanprash along with standard protective measures, 59.2% participants were male, the mean age was 32.12 years, and the mean BMI was 23.56 kg/m2. History of allergy to some material was reported by 14.7% participants in Group I and 17.3% participants in Group II. The majority of the participants in both groups had no addiction history. None of the participants had a history of COVID-19 in the family before enrolment in both groups. In Group I, almost 30% participants had moderate to too much stress; in Group II, 17% participants reported having moderate to too much stress. However, this difference between both groups is not statistically significant. The participants with different work profiles were enrolled and equally distributed in two groups [Table 1].
|Table 1: Baseline characteristics of the participants in both the groups|
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Assessment of efficacy
None of the participants in either group was found to be COVID-19 positive at the end of the study period. As the study revealed that no participant in any group was infected by COVID-19, participants were communicated telephonically for the next 4 months after completion of the study period for knowing the protection rate in both the groups. These follow-up data regarding the incidence of COVID-19 among the study participants revealed that four participants in Group I showed symptoms such as fever, cough, anosmia, and loss of taste and they tested COVID-19 positive as confirmed by RT-PCR. Out of these participants, one had to be hospitalized, whereas only two participants in Group II tested COVID-19 positive and were asymptomatic. Total six participants were diagnosed as COVID-19 positive within 2 months after completion of the study period. There was no incidence of any other infective diseases (bacterial /viral/ fungal / etc.) such as upper respiratory tract illness during the study period in both the groups.
Assessment of inflammatory and immune markers in 18 participants in each group showed that median IgG levels increased significantly from 1337.5 (1185, 1610.4) at baseline to 1361 (1126, 1675) on the 30th day in Group II (P = 0.016). The median IgE levels decreased significantly in Group I from 173 (90.5, 420) at baseline to 159 (79, 424.5) on the 30th day (P = 0.019); however, the values were within normal limits. All the other immune and inflammatory markers such as IgM, hsCRP, IL6, IL10, and TNF alpha did not show statistically significant changes both before and after the study period in any group and all the values were within normal limits [Table 2].
Assessment of safety
None of the participants in either group was found to be COVID-19 positive at the end of the study period. No adverse event was recorded during the study. The vital parameters of all the participants were within normal limits in both groups throughout the study. A statistically significant decrease in mean systolic blood pressure was observed in Group II at the end of the study period. However, the change is not clinically significant [Table 3]. All the hematological parameters in both groups were within normal limits both before and after the study [Table 4]. Mean blood urea, serum creatinine, and serum glutamic oxaloacetic transaminase (SGOT) levels were decreased in both the groups on the 30th day; whereas total protein, serum albumin, and serum glutamic pyruvic transaminase (SGPT) levels decreased and serum globulin increased in Group II on the 30th day. However, all these values were within normal limits at baseline as well as on the 30th day [Table 5].
| Discussion|| |
The study was based on the hypothesis that Chyawanprash could potentially be used as a safe prophylactic intervention along with standard precautionary measures, to prevent infection in the population having a high risk of exposure to the SARS CoV-2 virus. However, the protective effect of Chyawanprash as an add-on to the standard of care among HCWs functional at an isolation ward in a COVID-19 care hospital could not be undoubtedly confirmed in the present study as there was no incidence of COVID-19 cases in any group at the end of the study period, that is, on the 30th day. However, in the long-term follow-up after completion of the intervention period, the participants in the study group were found to be more protected from severe infection of COVID-19 as only two participants were RT-PCR positive after 2 months of completion of the study period and both were asymptomatic. However, in the control group, four participants were RT-PCR positive in the same duration, and one out of them had to be hospitalized.
In the current study, the immune-modulatory and adaptogenic effect of Chyawanprash was proposed to be assessed through comparing the change in inflammatory and immune markers in every fifth participant in both groups both before and after the study. The IgG levels increased significantly among the participants taking Chyawanprash; however, clinically the participants were normal. Serum IgG is an indicator of the humoral immune response. Its level represents the natural antibodies against the antigens commonly encountered by the individual. IgG is the predominant antibody in the serum and it carries the major burden of neutralizing bacterial toxins and binding to microorganisms to enhance their phagocytosis. The values of IgM, hsCRP, IL6, IL10, and TNF alpha did not change significantly in any group in this study. In previous clinical trials conducted to explore the immune-modulatory, adaptogenic, and cytoprotective effects of Chyawanprash, it is observed that a significant change in the immunity markers happens when it is given in a higher dose and for a longer duration [Table 6]. The classical dose for avaleha (linctus) preparation is almost 48 gm (as mentioned, 1 pala in Sharangdhar Samhita); however, Rasayana medicines are to be administered as per the digestive capacity and strength of the recipient. So in the present study, the standard dose of Chyawanprash as mentioned in the Ayurvedic Pharmacopoeia of India (Vol. 1, Part II) was administered, which was 12 g twice daily, and the duration of the intervention in the study was only for 30 days. Given the shorter time of Chawanprash administration, this study may not have yielded the same results as earlier clinical trials in proving its immunomodulatory effect.
|Table 6: Review of previous studies exploring the adaptogenic effect of Chyawanprash|
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The current study proved the safety and tolerability of Chyawanprash through the nonoccurrence of any adverse drug reaction and a comparison of hematological and biochemical parameters of the participants both before and after the study. However, on comparing this aspect with HCQ, it was recommended by the health policymakers in the country as a prophylactic measure during the COVID-19 pandemic, despite ample scientific evidence against its efficacy both prophylactically and therapeutically. Boulware et al. reported that HCQ failed to prevent symptomatic infection of COVID-19 whereas it was associated with more side effects compared with placebo. Another study revealed that no significant beneficial effect of using HCQ on the outcome of patients with COVID-19 was observed. Moreover, the risk of hypoglycemia due to HCQ would possess a significant risk for out-of-hospital use.
While promoting HCQ as a possible prophylactic solution to SARS-CoV-2 infection, the safety of the drug was demanded to be emphasized under closer scrutiny all over the world because of its potential to cause cardiac toxic effects and overall adverse outcomes, especially in people with underlying coexisting conditions that increase the risk of severe COVID-19. As per the revised advisory on the use of HCQ as prophylaxis for COVID-19 infection published on the website of Ministry of Health and Family Welfare (MoHFW), assessment of HCQ prophylaxis among 1323 HCWs indicated mild adverse effects such as nausea, abdominal pain, vomiting, hypoglycemia, and cardiovascular effects, and the data from the Pharmacovigilance program of India indicated that there have been 214 reported instances of adverse drug reactions associated with prophylactic HCQ use, including seven serious individual case safety reports with prolongation of QT interval on ECG in three cases. So, if HCQ is to be used, a clear informed choice needs to be offered to every contact, explaining the scarcity of evidence for its efficacy and its potential risks. On the other hand, Chyawanprash is a Rasayana medicine that is being prescribed by Ayurveda physicians since thousands of years to improve general body strength and vitality. It is especially indicated in patients having chronic respiratory disorders. The therapeutic value of Chyawanprash as an adjunct to antitubercular drugs to augment their bioactivity and prevent their side effects is proved in clinical trials.,Chyawanprash can be administered in all age groups in every season by people having normal digestive capacity, as proven by certain studies among children.
The variability in innate immune system components among humans is a main contributor to the heterogeneous disease courses observed for COVID-19. It is proven that the combination phytochemicals offers better antioxidant effects than single antioxidant therapy.Chyawanprash helps to balance the three doshas, namely Vata, Pitta, and Kapha (bodily humors/bioenergies regulating the structure and biofunctions of the human body). In the Ayurvedic perspective, the specific actions of herbs in Chyawanprash are at the metabolic level.Chyawanprash generally helps in eliminating the accumulated stool and so in improving digestive capacity when taken regularly. This enhances the nourishment and building up of the tissues and in maintaining immune homeostasis. Chyawanprash is a potent cardiotonic. It exerts antihyperlipidemic activity and alleviates metabolic impairments., Emblica Officinalis, which is the prime ingredient of Chyawanprash, shows antiatherogenic, anticoagulant, hypolipidemic, antihypertensive, antioxidant, antiplatelet, and vasodilatory effects, as well as lipid deposition inhibitory properties.,Chyawanprash also nourishes the brain cells, harmonizes neuronal activities, improves the memory, and enhances learning ability, storage, recall, and intellect. It relaxes the central nervous system, thereby acting as an anxiolytic and an antidepressant, and it alleviates insomnia. Research has also suggested its procholenergic activity and antiamnesic potential.,,
Considering all the earlier mentioned empirically proven benefits of Chyawanprash, the drug might have affected the digestion, metabolism, and overall body strength or stamina of the participants in the present study. It might have also reduced the anxiety and stress and improved sleep among HCWs. However, as the study was focused on evaluating Chyawanprash as a safe and effective prophylactic intervention against COVID-19 infection, all the earlier mentioned benefits were not measured and compared. Moreover, the study was conducted at an Ayurvedic hospital functioning as a COVID care center, which was the only feasible study setting then, when the pandemic had created panic among all and most general healthcare services were almost shut. So there are many chances that the participants were already consuming some Ayurvedic medicines such as Samshamani Vati, Giloy (Tinospora cordifolia) juice, Tulsi (Ocimum sanctum) juice etc. as immunity boosters before getting enrolled in the trial; as the study dealt with the prevention of an acute infectious disease, washout period could not be given before enrolment. The main limitations of our study were that it was conducted in a single COVID-19 care center, which was a designated government hospital with a manageable patient load, good infrastructure, and robust infection control practices. The risk of exposure here was not as high as general Out Patient Department (OPD) where asymptomatic and mild cases with initial ILI like symptoms may be dealt with before diagnosis or in other COVID-19 and non-COVID-19 public sector hospitals with a large patient burden, limited staff, inadequate PPE, and frequent breaches in infection control practices. Second, the participants were not screened for the presence of anti-SARS-CoV-2 IgM and IgG antibodies before inclusion as the study was designed before the first seroprevalence survey in India.
| Conclusion|| |
Chyawanprash can be safely administered in HCWs but its efficacy as an add-on intervention to the standard measures for preventing the COVID-19 infection could be proved by a clinical study conducted for a longer duration with a larger sample size and a higher dosage of the drug as had been effective in previous studies.
Compliance with ethics guidelines
The study was conducted according to the guidelines of the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Choudhary Brahma Prakash Ayurved Charak Sansthan, Khera Dabur, New Delhi (protocol code 3−58 Version-II approved on 19.05.2020). All patient data were anonymized while revealing the results.
Informed consent statement
Written informed consent was obtained from all subjects involved in the study for their participation and publication of data without revealing their identity.
Data availability statement
Raw data were generated at study centers. They were processed to the derived data supporting the findings of this study at CCRAS headquarters. They can be available from the CCRAS headquarters on reasonable request to the head of the council.
Patients were not involved in the study trial design or the dissemination of results.
The first draft of this article is published as preprint at the preprint server “medRxiv.org” doi:https://doi.org/10.1101/2021.02.17.21251899
Financial support and sponsorship
Conflicts of interest
The authors have no conflicts of interest to declare that are relevant to the content of this article. This study tested the efficacy of a drug that is not manufactured or marketed by the funding agency. So, the funders designed the study; analyzed the data collected at the study site; wrote the article; and decided to publish the results.
All the authors have read and agreed to this version of the article.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]