|
 
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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 6
| Issue : 4 | Page : 169-180 |
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Prophylactic effect of Ayurveda interventions in prevention of COVID 19 in selected containment zones of Delhi: A prospective open label community based study
BCS Rao1, Babita Yadav1, MM Sharma1, Sophia Jameela1, Rakesh Kumar Rana1, Richa Singhal1, Bhagwan Sahai Sharma1, Shruti Khanduri1, Deepa Makhija2, Bharti Gupta1, Adarsh Kumar1, Srikanth N1, Kartar Singh Dhiman1, Field Investigators3
1 Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
2 Central Ayurveda Research Institute (CARI), New Delhi, India
| Date of Submission | 16-Aug-2022 |
| Date of Acceptance | 17-Nov-2022 |
| Date of Web Publication | 05-Dec-2022 |
Correspondence Address:
Dr. Babita Yadav
Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_124_22
BACKGROUND: The exponential rise of cases and associated morbidity and mortality has managed to make COVID-19 a serious threat. Minimising the transmission of disease by prevention and control strategy forms the core-pillar of response. Ayurveda with its holistic approach can potentially promote disease prophylaxis both at the individual as well as community levels. This clinical study was executed in a community set-up to explore the potential of Ayurvedic interventions in COVID-19 prophylaxis. MATERIALS AND METHODS: The study was conducted as an open label community based study in six selected containment zones of Delhi on 9200 individuals with an objective to record the incidence of COVID-19 in these areas. The selected Ayurvedic Interventions (Ashwagandha, Maha Sudarshan Ghan Vati, Samshamani Vati) were distributed in the dose of two tablets of 250 mg each twice daily after food with lukewarm water for a period of one month. Onset of any COVID-19 related clinical symptoms, patient satisfaction in general health parameters and incidence of ADR/AE were taken as outcome measures. RESULTS: 9010 participants were recruited with mean age of 37.9 years. A total of 12 participants (0.17%) were reported positive during the intervention period, among 279 who underwent testing (because of contact tracing or symptoms). Participants who were devoid of any symptoms throughout the trial period were 98.8%. Statistically significant improvement was observed in parameters of general well-being at the end of study period. CONCLUSION: Ayurveda interventions demonstrated potential as a safe prophylactic measure against COVID 19 with comparatively good compliance and minimal adverse effects. Keywords: Ashwagandha, community study, containment zone, COVID-19, Delhi, Maha Sudarshan Ghan Vati, prophylaxis, Samshamani Vati
How to cite this article:
Rao B, Yadav B, Sharma M, Jameela S, Rana RK, Singhal R, Sharma BS, Khanduri S, Makhija D, Gupta B, Kumar A, Srikanth, Dhiman KS, Investigators F. Prophylactic effect of Ayurveda interventions in prevention of COVID 19 in selected containment zones of Delhi: A prospective open label community based study. J Res Ayurvedic Sci 2022;6:169-80 |
How to cite this URL:
Rao B, Yadav B, Sharma M, Jameela S, Rana RK, Singhal R, Sharma BS, Khanduri S, Makhija D, Gupta B, Kumar A, Srikanth, Dhiman KS, Investigators F. Prophylactic effect of Ayurveda interventions in prevention of COVID 19 in selected containment zones of Delhi: A prospective open label community based study. J Res Ayurvedic Sci [serial online] 2022 [cited 2023 Mar 25];6:169-80. Available from: http://www.jrasccras.com/text.asp?2022/6/4/169/362651 |
Trial Registration: CTRI/2020/05/025069
| Introduction | |  |
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), causing coronavirus disease 2019 (COVID-19), was declared a global pandemic on March 11, 2020 by the World Health Organization (WHO),[1] and has wreaked havoc in more than 214 Countries and territories affecting more than 632,953,782 confirmed cases of COVID-19, including 6,593,715 deaths, reported to WHO as on 8 November 2022.[2] The disease that began as an epidemic managed to reach gargantuan proportions and emerged as a global pandemic, increasing morbidity and mortality, stigmatization, stress, anxiety, among the quarantined and isolated people, while posing enormous health, economic, environmental and social challenges to the entire world. Current estimated mortality of COVID-19 for overall infected population is 0.25–3.0% whereas it increases to >14% among elderly (over 80 years), 10% in associated CVD and 7% in associated diabetes.[3]
Despite the unprecedented effort vested globally, the disease is spreading beyond limits and until now, no effective intervention or strategy could be identified to contain the disease. Clinical trials have begun to identify effective and safe treatment regimens, but efforts to identify drugs that can be repurposed and used, off-label, remain limited.[4] Traditional Chinese Medicine has proven to be effective in China, where it has been actively integrated into the management strategy.[5] In India also, existing health resources of the country are being utilized to tackle the situation and it is imperative to integrate AYUSH resources with the existing health care for seamless, cost effective and beneficial outcomes in this pandemic scenario.
Ayurveda as a therapeutic choice for SARS-CoV-2 as stand-alone or add-on to contemporary medicine for better prognosis and to prevent complications is an area to be explored further by integration into the mainstream health care. Ayurveda can be utilized in an effective manner in the SARS-CoV-2 scenario in prophylactic, therapeutic and rejuvenative/rehabilitative arenas. Prophylaxis in the form of Pre-Exposure Prophylaxis (PrEP– where the intervention is taken continuously during a period of risk) and/or Post Exposure Prophylaxis (PEP – where the intervention is taken for a limited time, starting as soon as possible after exposure to a known case) comes right under the perspective of Ayurveda, which propounds the importance of prevention of diseases through a holistic approach. Ayurveda has described the concept of Vyadhikshamatva as the inherent ability of the body to defend against diseases and eliminate the disease causing agents by negating internal discordance within the body. The inherent Vyadhikshamatva of each individual varies depending upon dietary, lifestyle, and individual genetic as well as environmental aspects and it is this individual specificity, which outlines how disease manifests in the body.
CCRAS in collaboration with the Government of Delhi had taken an initiative to distribute Ayurveda interventions at the doorstep through local volunteers, and Ayurveda professionals, including doctors, medical students, and other scientific staff of CCRAS to the population of identified six containment zones of Delhi. The interventions, Viz., Ashwagandha Tablet, Maha Sudarshan Ghan Vati and Samshamani Vati, wereselected based on their potential as immune-modulators and specific ability to mount an active defense mechanism in case of possible encounters with an infectious cause and proven clinical safety.
In the scenario of COVID-19 pandemic, the general guidelines issued by Government of India was to enact a Nation-wide lockdown to contain the spread of the disease by reducing people to people contact, thereby breaking the chain of transmission. As part of this strategy, localities, districts etc. were marked as red, orange or green depending upon the prevalence of infected cases, as decided by the state administration. Containment zones are localities, neighborhoods, etc from where positive cases were reported and demarcated by the State administration, district administration, Municipal Corporation or panchayat bodies, with restricted entry and movement within. So a community-based study was conceived to deliver the benefits of Ayurveda to the public, who are at risk for contracting the disease due to exposure. Community-based intervention studies are usually designed to understand how the error variance that exists in community settings (that would be controlled in a randomized clinical trial) affects the potency of its intervention without addressing the other confounding factors. It was expected that this study would generate a generalizable data, which would be effective in a public health setting, which is the need of the hour where fortification of immune system is an effective method to limit the disease spread even if the chances of exposure are present. Due to the restrictions imparted by the COVID situation, and considering the possible non-willingness of the public to interact with the interview personnel amidst the pandemic scare, the study was planned as a single arm, uncontrolled trial.
The primary objective of the study was to record the incidence of COVID-19 in six containment zones of Delhi where selected Ayurvedic interventions were provided as prophylactic measure. Secondary objectives were to assess the change in parameters of well-being such as appetite, bowel habit, sleep, physical strength and psychological well-being and documentation of ADR/AE reported by the participants during the intervention period.
| Materials and Methods | | |
Study design
This is an open label community based study conducted in the containment zones of Delhi identified by the Delhi Government.
Study setting
The study was conducted at six containment zones of Delhi, viz. Budhnagar, Inderpuri, Dinpur Village, Savitri Nagar, Malviya Nagar, Nangloi selected by the Directorate, Department of AYUSH, Government of Delhi for providing prophylactic Ayurveda interventions. The participants from these sites were selected as per the selection criteria.
Study Participants
Participants of any gender in the age group 18–70 years residing in any of the selected six containment zones and willing to participate and comply with the study protocol were included in the study. COVID-19 positive cases (confirmed by RT-PCR) with or without symptoms, people already using any of the trial interventions at least 30 days prior to the initiation of trial, pregnant or lactating females and those with known allergy to any of the ingredients of the interventions were excluded from the study. Participants not willing to provide the signed informed consent or any other criteria, which, as per the investigators would jeopardize the trial, were also considered for exclusion from the trial.
Informed consent and ethical consideration
The Institutional Ethics Committee of Central Ayurveda Research Institute, New Delhi had approved this study. The trial was registered prospectively in the Clinical Trials Registry of India (CTRI/2020/05/025069). Digital informed consent was obtained from all the participants who expressed willingness to participate in the study and data collection was done after adequate information disclosure to the participants. Due to the communicability of SARS-CoV-2, and to protect study personnel from infection due to door-to-door medicine distribution, digital informed consent was obtained through different methods like by sending information to the participants through messages and emails. In some of the participants who were using a smartphone, the study staff requested the participants to send the image of the signed consent form. However, in Delhi also there are some areas where there is very poor connectivity of internet coverage, the content of the study information sheet and consent were shared as an SMS, to which their consent was instructed to be sent as “I agree” or “Yes.” The obtained consent was then printed and stored with other study documents or scanned into the electronic format and stored. Confidentiality was maintained throughout the study period.
Framework for the implementation of the community-based study in containment zones of Delhi
The CCRAS had designed and implemented the community-based study aligning with the advisories and guidelines issued by the Ministry of Health and Family Welfare (MoHFW) and Ministry of Ayush (MoA), Government of India.
Ayush professionals, including Research Officers (Ayurveda), Senior Research Fellows, Consultant (Ayurveda) and other paramedical staff from CCRAS headquarters and CARI New Delhi, were identified as team members to execute the distribution of Ayurveda interventions in selected containment communities of Delhi; Director and Senior Research Officers liasoned with the Directorate, Department of Ayush, Government of Delhi /health department of North Delhi Municipal Corporation /COVID-19 cells at local levels. The study personnel did the systematic documentation through google forms, data entry in electronic formats; and telephonic follow-up of the study participants. The field staff was trained properly on the methodology for getting informed consent, data collection, and data sharing. The baseline data of this study was collected through face-to-face interviews at the day of dispensing trial interventions, however follow-ups on days 07, 15 and 30 were done through telephonic interviews only.
For the co-operation and getting the details of containment zones of Delhi, request Letters were sent to the concerned authorities of Government of Delhi (Ayush Directorate)/Goverment of India (Health department of North Delhi Municipal Corporation). After getting the due approvals, the representatives of the CCRAS visited the selected containment zones of Delhi to survey the feasibility of distribution of Ayurveda interventions in that area.
Government of Delhi also nominated few Volunteers who were already performing their duties in the containment zones to chalk out the plan. Investigators in the field trained them to assist the medicine distribution as per the plan. Other than Ayurveda interventions, preventive measures as per the COVID-19 protocol issued by ICMR including physical distancing, sanitization techniques and use of hand wash and mask etc was also informed to the population of selected containment zones.
Interventions
Three classical Ayurvedic formulations, viz; Ashwagandha Tablets, Guduchi Ghanvati, and Maha SudarshanGhanvati were selected for the study. The participants enrolled for the study were provided with any of the three interventions in the dose of two tablets of 250 mg each twice daily with water after food for a duration of 30 days. The participants were also advised to follow MoA directives for maintenance of health during COVID-19 scenario.[6]The study medicines were procured from GMP certified Pharmaceutical company, Indian Medicines Pharmaceutical Corporation Limited. Quality control and safety parameters of the ingredients and the formulation complied with Ayurvedic Pharmacopeia of India (API) limits/ in-house limits as appropriate.
Description of interventions
Ashwagandha tablet contain aqueous extract of Withania somnifera Dunal. (Fam. Solanaceae)]. Ayurveda attributes Rasayana (rejuvenative) andBalya(enhancing the inherent factors accredited to various aspects of Bala- strength, immune regulation, general health) properties to this botanical.[7]
Guduchi Ghanvati is a unique Ayurvedic classical preparation, which is prepared from aqueous extract of Guduchi (Tinospora cordifolia Miers.) stem. Guduchi Ghana[8](concentrated form of decoction) is the secondary Kalpana (dosage form) derived from the primary Kalpana, i.e. Kwatha (decoction). Ayurveda classics have accorded various properties to Guduchi such as Balya (promoting Bala), Deepana (pharmacodynamics associated with augmenting metabolic transformation at GIT, cellular and tissue level), Rasayana(rejuvenative) and Jvaraghna (antipyretic),[9]Vayahsthapana[10](ability to perpetuate healthy life and restore vitality).
Maha Sudarshana Ghanvati is a polyherbal Ayurvedic formulation used by traditional Ayurvedic physicians in the management of fever, cold, malaria, liver and spleen diseases etc.[11] The major ingredient is Kiratatikta (Swertia chirata) which forms 50% of the total proportion of the ingredients along with other 51 Ingredients.[12] Acute and chronic toxicity studies conducted by CCRAS revealed the safety of the above said formulation in the experimental animals.[13]
Outcomes
The primary outcome was proportion of participants reported the COVID-19 (confirmed by RT-PCR, done as per the instructions from a doctor, either due to manifestation of ILI like symptoms or due to contact with positive cases) during the intervention period. Incidence of severe COVID 19 (admitted in hospital and requiring ventilation and/or associated with multi-organ failure as reported by hospital and mortality due to COVID 19 reported by the family members of the deceased, among the COVID 19 positive participants were included as the secondary outcome measures.
Participant reported incidence of any symptoms such as cough, fever, sore throat, rhinitis, loss of appetite, constipation, abdominal bloating, anxiety etc and reported change in parameters such as appetite, bowel habit, sleep, micturition, physical strength and psychological well-being rated through a 10 point scale, with least satisfaction at zero and maximum possible satisfaction at 10, was also included as secondary outcome measures. Onset of any ADR/AE reported by the participants during the intervention period of 30 days was also included as secondary outcome measure.
Sample size
Assuming the incidence of COVID-19 in the containment zones would be 2% and expecting a relative margin of 20% in this incidence, the sample size was calculated as 4900. (utilizing the formulae 4*p*(1-p))/e^2, where p is taken as COVID-19 incidence and e, is a relative error of margin). Further containment zones are taken as small clusters and for adjusting the cluster effect, a design effect of 1.5 was considered for the sample size increment (which is 4900*1.5= 7350). Adding the attrition rate of 25%, number of participants to be enrolled in the study was calculated 9188, which was rounded off to 9200.
Data collection, management, and analysis
The field personnel who were involved in the trial were Research Officers/Ayurveda Doctors working with the Central Council of Research in Ayurvedic Sciences and National Ayurveda Students and Youth Association (NASYA). The doctors/ investigators did the screening, recording of the baseline data, counselling of the participants regarding AYUSH Directives for prevention and guidance on usage of trial interventions. The task was delegated to qualified professionals so as to enable proper clinical screening in the absence of laboratory investigations (which was difficult to execute in the COVID 19 situation, and also in a large sample sized community based study), and also to address any concerns or queries that would arise regarding the safety or efficacy of the trial interventions. The investigators were trained on the social etiquettes and prevailing protective measures, study methodology, data entry process etc. They were provided with prophylactic measures and were equipped with Personal Protective Equipment etc. before being deployed to the containment zones and were tested for COVID – 19 by RT-PCR before the initiation and after the completion of the study.
The stepwise process involved in the recruitment of participants is given in [Figure 1].
Questionnaire for data collection
The desired outcomes were captured through a semi-structured questionnaire. The first part was intended to capture the basic demographic details like age, gender, name of the containment zone, mobile number, presence of co-morbidities, history of travel to either COVID hotspots within the country or overseas travel, exposure to COVID positive cases, use of preventive medicines, details of medications for any other illness etc.
The questionnaire also captured presence or onset of symptoms such as cough, fever, sore throat, rhinitis, loss of appetite, constipation, abdominal bloating, anxiety etc at the baseline and subsequent follow-ups respectively. The next section in the questionnaire was intended to capture changes in parameters such as appetite, bowel habit, sleep, micturition, physical strength and psychological well-being self-rated by the participant through a 10 point scale (from 0 to 10). The next segment had questions to assess the compliance to medicine (evaluated as 100%, 76–99%, 51–75%, 26–50% and <25%), which was followed by questions intended to record the COVID-19 testing status, COVID positive status and severity of disease (asymptomatic/symptomatic/hospitalized). There were provisions to capture any AE/ADR that manifested during the intervention period. The final question was targeted to capture the response of the participant as to whether they observed any noticeable change in existingco-morbidities after intake of AYUSH interventions.
The field personnel recorded the data in the electronic format directly at the baseline and the interventions were distributed with special instructions regarding use and on AYUSH directives for prevention of disease. The subsequent follow-ups were conducted through telephonic interviews, by the field personnel on7th, 15th, 22nd and 30thdays and recorded in the pre-designed e-format.
Statistical methods
The data on descriptive variables have been presented as frequency (%) and for continuous variables have been presented as Mean (SD). Paired sample t-testhas been applied to compare the effect of interventions on parameters of general well-being like appetite, sleep, physical strength, psychological well-being, etc. Independent sample t-test was used for between group comparisons. Chi-square test has been used to compare the data among the three intervention groups. The data has been analyzed using STATA 16.1.
The data of non-responders who failed to report the outcomes in the subsequent follow-ups either due to non-willingness, non-responsiveness to telephonic interview attempts, inability to communicate due to faulty mobile numbers provided etc were excluded from the analysis. Demographic data of all the participants (9010) who fulfilled the selection criteria were used for analysis irrespective of whether the data of follow-ups were available or not. The data of 7087 participants who responded to the telephonic interviews were included for analysis of the outcome measures.
| Results | | |
12800 people were screened and 9010 fulfilling the selection criteria were enrolled for the study between 16th May to 23rd May, 2020. To these participants any of the three selected Ayurvedic interventions were given for a period of 30 days. The outflow of participants is given in [Figure 2].
Maximum participants (5981) were recruited from Budhnagar with a population size of 42000, followed by 1345 from EA Block, Inderpuri, 647 from Savitri Nagar, 545 from Dinpur Village, 304 from Nangloi, West Delhi, and 188 from Gandhi park, South Delhi. Samshamani Vati alone was distributed in Dinpur, Malviya Nagar and Nangloi, while all three interventions were distributed in other areas. The outflow of participants, including the number of participants who received each type of intervention within each containment zone is depicted in [Table 1]. Samshamani Vati was provided to a total of 4416 participants(49%), which accounts for about half of the total population. Ashwagandha tablets and Maha Sudarshan Ghan Vati were given to 29% and 22% respectively. | Table 1: Distribution of participants in three intervention groups across the selected containment zones
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Demographic profile and baseline characteristics
In the study, mean age of the participants was 37.9 years and majority of the participants were males 4877 (54.1%). The majority of the enrolled participants were not having any co-morbidities (87.7%). Among those with co-morbidities, diabetes (4.8%) and hypertension (4.6%) were the most common. Neurological disorders, cardiovascular disorders, COPD, skin diseases and gastro-intestinal disorders were recorded in very small proportions. 11.1% of the participants reported to taking concomitant medications. The demographic data of the participants classified as per the trial intervention provided is given in [Table 2].
The proportion of participants, who had history of travel to COVID 19 hotspots, regionally or overseas after the initiation of lockdown and the upsurge of COVID cases, was recorded to be nominal (0.3%). Though the scare of the pandemic outbreak was at large and social distancing and preventive regime was in place, it was observed that very few participants were taking any AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) interventions for prevention of COVID-19, however participants were following Ayush directives for prevention of CoVID-19. The proportion of participants who took interventions for COVID 19 prevention in the three months prior to the initiation of the study was recorded as 1.2% (Ayurveda), 1.0% (Yoga and Unani each), 0.3% (Homoeopathy) and 0.03% (Siddha). About 95.7% of participants were not using any medicine(excluding home remedies) for disease prevention, but 46.1% of the total population was following the Ayush directives for self-care aimed at promoting health in the midst of COVID-19 [Table 3]. | Table 3: Baseline characteristics of the participants w.r.t. treatment regimen followed for prevention
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Baseline trends of utilization of AYUSH measures
Pranayama and meditation alone was practised by 5.1% of the participants, while Chyavanaprasha as a choice for prevention was used by 3.2%. Use of herbal tea / decoction (Kadha) made from Tulsi (basil), Dalchini (cinnamon), Kalimirch (black pepper), Shunthi (dry ginger) and Munakka (raisin) was reported by 14.9% of participants, while use of haldi-milk was observed in 18.2%. The habit of drinking boiled water was practised by 45.2% of the participants, which might be attributed to safe and healthy (water) drinking habits that is part of the Indian culture. A relatively small proportion of participants practiced nasal application of sesame oil/coconut oil / ghee and gargling/ oil pulling, with sesame oil or coconut oil (1.1% and 2.0% respectively).
Impact of interventions on outcome measures
During the study period, 279 (3.09%) participants suspected of COVID 19; either due to manifestation of clinical symptoms resembling COVID 19 or due to contact with diagnosed cases, underwent laboratory testing by RT-PCR, among which 12 cases tested positive. Among the 3501 patients who were using Samshamani Vati for prophylaxis, 120 were tested, out of which 9 participants tested positive. Among the 2121 participants who were givenAshwagandha, 41 were tested, and only one (01) tested positive. Likewise, among the 1465 participants who were given Maha Sudarshan Ghan vati, two (02) were tested COVID 19 positive among the 118 who underwent testing [Table 4]. The proportionof COVID 19 in the participants recruited from the selected six containment zones was 0.17%, which is lower than the incidence rate of containment zones. Though 12 positive cases were reported, none of the cases were severe enough to require ventilation or hospitalization. No death was recorded among the participants.
98.8% of the participants did not report any symptoms during the weekly follow-ups till the 30th day [Table 4]. Fever (08), Cough (02), sore throat (02), sneezing (04), Running nose (05), breathing difficulty (08), headache (15), fatigue (22) and loss of appetite (30) were the symptoms recorded in minimal number of participants.
Variables of well being like appetite, bowel habits, bladder function, sleep, physical strength and psychological wellbeing were assessed on a 0 to 10 scale as reported by the participants with least satisfaction at zero and maximum possible satisfaction at 10.Samshamani Vati and Ashwagandha tablets demonstrated statistically significant improvement in all the assessment parameters (p-value< 0.001). Maha Sudarshan Ghanvati demonstrated improvement in appetite and physical strength only. However, statistically significant difference between three intervention groups was observed in bowel habits, bladder function and sleep (p-value<0.05) [Table 5].
Drug compliance
Considering the various strategies executed by the government to contain the spread of COVID 19, it was difficult to use other objective methods to quantify the use of intervention in the participants and self-reporting by the participants during the follow-ups was the method used here to assess the drug compliance. Around 52% of the total participants, reported 100% compliance and 39.6% demonstrated 76–99% compliance wherein the participants missed few days, but still maintaining a satisfactory adherence. Very few participants reported adherence less than 50% [Table 6]. | Table 6: Participant compliance/adherence to the study interventions at the end of 30 days
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Adverse event/ adverse drug reaction
Among the 9010 participants, 44 AE were reported. Among the 3501 participants, who were given Samshamani Vati, 11 AE were reported, while 21 AE (among 2121) were reported in the Ashwagandha group. Twelve reports of AE were made in the Maha Sudarshan Ghan Vati group out of 1465 participants [Table 7]. These AE were reported during weekly follow-ups through telephonic interview. | Table 7: List of suspected adverse events reported during the follow-ups
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The adverse events were very few and mainly related to the gastrointestinal tract such as acidity, bloating, constipation, gastritis, and few reports of dryness of skin, burning sensation of skin, feeling of increased body temperature etc. has been recorded during the intervention period. An attempt was made to establish the causality between the events reported and the interventions through global clinical introspection method by adding a question in the electronic format seeking the opinion of the investigator as to whether there is any relation with the intervention and the AE recorded. However, the data generated was inconclusive and is not apt to establish causality between the interventions and the symptoms.
The reported complaints were handled by dose alteration or changing the food and drug timings etc. However, none of the complaints was serious enough to warrant medication or hospital visit.
| Discussion | | |
Clinical research executed in community settings addresses key implementation and feasibility issues, given the current emphasis on evidence based medicine. It is most appropriate to gather evidence needed for validation of science from the very primary settings where it would be applied upon.
During the intervention period, only 3.93% of patients underwent RT-PCR testing for COVID 19, among which only 12 turned out be positive. In the few positive cases reported (0.17%), the disease was self-limiting without venturing into complications or death. From which, it could be assumed that, the intervention was indeed effective in providing prophylaxis against COVID-19.
During the time when this study was executed, HCQ was promoted as a prophylactic agent for COVID 19 prevention.[14] A post-exposure prophylaxis randomized controlled trial reported a non-significant difference in incidence between HCQ and placebo group (11.8% vs. 14.3%, P = 0.35).[15]
During the intervention period, 98.8% of the participants did not report any symptoms similar to ILI. Samshamani Vati and Ashwagandha tablets demonstrated statistically significant improvement with p-value <0.001in the parameters of well-being in terms of participant satisfaction in appetite, bowel habits, micturition, sleep, physical strength and psychological wellbeing. Ayurveda believes in maintenance of health and wellbeing as a primary target, and the interventions succeeded in maintaining the health of the participants in an optimal range in spite of the surge in COVID-19 cases and subsequent physical and psychological illness.
It is a basic requirement in medical research to establish that a medication occupies and engages its target at appropriate doses to produce intended response., which is assessed through drug compliance especially when the intervention is indicated for a prophylactic purpose. The participant’s adherence to trial intervention was assessed through telephonic follow-ups and it was observed that more than half of the participants showed 100% compliance, and only 0.8% demonstrated less than 50% compliance. The results could be used to surmise that study maintained intervention fidelity throughout the intervention period, without producing discomfort to the participant or palatability issues, etc. The need for an active preventive measure might also have ensured adherence.
Very few participants reported onset of AE during the trial period, majority of which were restricted to GI symptoms such as acidity, bloating, constipation, gastritis and other generalized symptoms such as dry skin, generalized burning sensation or a feeling of increased body heat etc. These symptoms were self-limiting (grade 1 severity) and were managed by slight dose alteration, advice to take medicine at least one hour after food, etc.
In a cross-sectional study carried out among doctors taking HCQ prophylaxis for COVID-19, most frequently reported AE are abdominal pain, nausea, and headache (10% or more) followed by rash, pruritus, diarrhea, vomiting, and blurred vision. Other uncommon adverse effects included alopecia, bleaching of hair, abnormal liver functions, dizziness, sensorimotor disorders, retinopathy, tinnitus, and nervousness and serious skin hypersensitivity reactions, cardiac arrhythmias, cardiomyopathies, bone marrow depression, hypoglycemia, neuro-myopathy, seizures, vertigo, ataxia, and psychosis.[16]
Considering the paucity of evidence to substantiate the prophylactic potential of any drug intervention, sprucing up individual health and inherent immune mechanism in a harmonious way to fend off infections and to live a healthy life through use of Ayurvedic interventions and lifestyle regime is a good call. Being a large sampled study in a community setting, the results may be generalized as to select these drugs as potential choice for mass prophylaxis against COVID-19.
Advantages and limitations
The advantage of the study was that it was conducted in a large sample size, absorbing the community assistance, using local volunteers, and promoted community empowerment through prophylactic interventions and baseline disease awareness and lifestyle guidance, during a pandemic. Being a community based study; it has an added merit of providing a better translational value to the study, addressing the social issues also along with the physical and mental wellbeing.
The study was conducted as a single arm study without a control group and hence there are limitations for studying the role of the trial interventions in terms of its effectiveness. The initial visit was done through face-to-face interview, but follow up data were recorded by telephonic interview and non-response was a challenge due to which, data of only 7087 (77%) participants were available for analysis of outcomes. Objective assessment parameters could not be included in the outcome measures, due to the study being a large community based study and due to the Government measures such as lockdown, social distancing etc, which made frequent visits to collect blood samples or conduct detailed clinical evaluation practically impossible. Though only 44 AE were reported, causality could not be established.
| Conclusion | | |
Ayurveda interventions demonstrated potential as a safe prophylactic measure against COVID 19 with comparatively good compliance and minimal adverse effects.
Acknowledgment(s)
Special thanks to Dr. Raj K. Manchanda, Director AYUSH, Directorate of AYUSH, Dr. Anjana Kaushal, CDMO-South West District, Delhi Govt. cmo sw-dhs-delhi, Dr. Sunita Prasad, CDMO-South West District, Delhi Govt. Dispensary, Dr. Ashok Jamrani, CDMO-New Delhi District, Dr. Nilesh Ahuja, AYUSH District Medical Officer (New Delhi/South West/ West Zone) and Dr. G.C. Malik, CDMO-South District, Delhi Govt. for extending their support in execution of this study by allotting the containment zones as well as their volunteers in the field. Members of DSMB; Dr. Nandini Kumar, former DDG, ICMR; Prof. Dr. Padma, AIIMS, New Delhi; Dr. M.S. Baghel, Former Director, IPGT&RA; Dr. Nirmala Rege, Head, KEM Hospital; Dr. Madan Godbole, Prof. SGPGI, Lucknow; Dr. Vishnu Vardhan Rao, Director, NIMS, ICMR, New Delhi; Dr. Galib, Associate Prof., AIIA. Doctors of NASYA team viz Dr. Monika Aharia, Dr. Alok Anand Jha, Dr. Jhanu Chakma, and Dr. Priyanka Jha.
Field Investigators
Dr. B.R. Meena, A.D. (Ay.); Dr. H. Panigrahi R.O. (Ay); Dr. U.R. Shekhar Namburi, R.O. (Ay.); Dr. Sunita Mata; Dr. Renu Singh; Dr. Vipin Sharma, R.O (Ay.); Dr. Avinash Jain, R.O. (Ay.); Dr. Sakshi Sharma, R.O. (Ayu.); Dr. Seema Jain, R.O. (Ayu.); Dr. Azeem Ahmad R.O. (Ay); Dr. Mukesh Chicholikar, R.O. (Ay.); Dr. Kishor Gavali, R.O. (Ayu.); Dr. Kalpana Kachare, R.O. (Ayu.); Dr. Rakesh Narayan, R.O. (Ay.); Dr. Neha Dubey, R.O. (Ay.); Dr. Lalita Sharma, R.O. (Ay.); Dr. Shaizi Layeeq, R.O. (Ayu.); Dr. Shweta Mata R.O. (Ayu.); Dr. Ashwin Chandra, R.O. (Ayu.); Dr. Sudha Kumari, R.O. (Ayu.); Dr. Rajkala, R.O. (Ayu.); Dr. Shweta Chaudhary, R.O. (Ayu.); Dr. Nandini, R.O. (Ayu.); Dr. Shobhit Kumar, R.O. (Ay.); Dr. Raman Kaushik, R.O. (Ay.); Dr. Deepak Londhe, R.O. (Ay.); Dr. Ramavatar Sharam, R.O. (Ay.); Dr. Bidhan Mahajon, R.O. (Ay.); Dr. Ashwathy Kutty, R.O. (Ay.); Dr. Shiv Shankar Rajput, R.O. (Ay.); Dr. Amit Madan, R.O. (Ay.); Dr. Kishore Patel R.O. (Ay.); Dr. Jai Prakash Ram R.O. (Ay.); Dr. Ratheesh P., R.O. (Ay.); Dr. Pankchakshari Patil, Consultant (Ay); Dr. Akansha, SRF (Ay.); Dr. Shilpi, Sr. Consultant (Ay.) Dr. Arun Goyal, Con. (Ay.); Dr. Anu Kaul, Consultant (Ay); Dr. Devayani, SRF (Ay); Dr. Rohit, SRF (Ay.); Dr. Sahil Garg, SRF (Ay.)
Financial support and sponsorship
This study was funded by Central Council for Research in Ayurvedic Sciences(CCRAS), Ministry of Ayush, Government of India.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]
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