Chyawanprash for the prevention of COVID-19 infection among healthcare workers: A Randomized Controlled Trial

Abstract

Background: Coronavirus disease 2019 (Covid19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARSCoV2). For persons who are at high risk of exposure, the standard of care is personal protection from getting infected. Whether Ayurvedic rasayana drug like Chyawanprash can prevent symptomatic infection in frontline health care workers is unknown. Objective: To evaluate the effect of the combination of Chyawanprash and Standard Preventive Regimen compared to the use of Standard Preventive Regimen alone on the proportion of RT-PCR confirmed COVID 19 infections among frontline healthcare workers (HCWs). Methods: An open label randomized controlled trial was conducted in the HCWs between 25 to 60 years age currently working in an environment with chance of direct exposure to COVID 19 cases. The interventions to be compared in this trial were Standard Preventive Regimen as per institutional guidelines and based on their roles (Group I) and Ayurvedic Intervention viz., Chyawanprash 12 g twice for 30 days from day of randomization plus Standard Preventive Regimen (Group II). The incidence of RT PCR confirmed COVID19 cases in both groups, was the primary outcome measure. Evaluation of the safety of the study drug (by any statistically significant change in various biochemical and hematological parameters and occurrence of any adverse drug reactions); incidence of any other infective diseases (bacterial / viral / fungal / etc.) like upper respiratory tract illness during the study period and any change in the immunoglobulins like IgG, IgM and IgE and inflammatory markers like TNF alpha, IL6 and IL10 were the secondary outcome measures. Results: Out of 193 participants who completed the study, no participant in both groups was COVID 19 positive at the end of one month. In post intervention follow up, 4 subjects in Group I and 2 subjects in Group II were COVID 19 positive. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters was observed before and after the study. Statistically significant rise in Serum IgG level was seen in Group II but other inflammatory and immune markers did not show statistically significant difference. Conclusion: Chyawanprash was well tolerated by all the participants in the intervention group but to prove its adaptogenic effect and efficacy as an add-on to the standard care in preventing the occurrence of COVID 19, clinical trial for longer duration with larger sample size is needed. Trial registration: Clinical Trials Registry of India vide CTRI/2020/05/025275 dated 20/05/2020 Date of IEC approval: 19.5.2020 Keywords: Adaptogen, Ayurveda, Health personnel, Prophylaxis, Rasayana, SARS CoV 2

Effectiveness of infection prevention and control interventions, excluding personal protective equipment, to prevent nosocomial transmission of SARS-CoV-2: a systematic review and call for action

“…Six of these studies were randomised control trials while one was a non-randomised trial. Studies were conducted in Argentina( 33 ), Canada( 34 ), India( 35 ), Pakistan( 36 ), Spain( 37 ), and the USA( 34 , 38 ). All studies evaluated efficacy of interventions in healthcare workers only, with no studies conducted in patient populations.…”

“…Six studies evaluated the use of pre-exposure prophylaxes (hydroxychloroquine( 34 , 37 , 38 ), bromhexine hydrochloride( 39 ), ivermectin and iota-carrageenan( 33 ), chyawanprash (a herbal supplement) ( 35 )), while one study( 36 ) evaluated the effectiveness of an audio-visual triage system.…”

“…Number of participants in RCTs ranged from 50 to 1483. Abella et al( 38 ), Chahla et al( 33 ), Grau-pujol et al( 37 ), and Gupta et al( 35 ) used polymerase chain reaction (PCR) tests to identify SARS-CoV-2 infections while Mikhaylov et al( 39 ) and Rajasingham et al( 34 ) used a combination of laboratory tests and clinical symptoms.…”

“…All three RCTs evaluating hydroxychloroquine( 34 , 37 , 38 ) were stopped early as they were underpowered to detect any clinical significance. The trial evaluating chyawanprash( 35 ) was also underpowered. The RCT evaluating bromhexine hydrochloride( 39 ) did not find statistically significant results between the two arms (intervention: 2/25 (8%), control group: 7/25 (28%), p = 0.07) while the RCT evaluating ivermectin and iota-carrageenan( 33 ) found a protective effect of the intervention (intervention: 4/117(3.4%), control: 25/117 (21.4%), p=1x10 -5 ).…”

“…Two studies( 34 , 38 ) noted that authors received income from pharmaceutical companies, not funding the work related to the studies. In one study( 37 ), a pharmaceutical company partly funded the study while in another study( 35 ) it was unclear whether a drug under investigation was donated. One study( 36 ) did not include a statement on conflict of interest while another( 33 ) did not identify any conflicts of interest.…”