|Year : 2020 | Volume
| Issue : 3 | Page : 88-91
Benefits of mouth-dissolving turmeric lozenges among health-care workers: An Indian experience during COVID-19 pandemic
Niharika Gill1, Pranauti Mestry2, Manjusha Rajarshi3
1 Department of Medicine, K. J. Somaiya Hospital and Research Centre, Mumbai, Maharashtra, India
2 Department of Ayurveda and Panchkarma, K. J. Somaiya Hospital and Research Centre, Mumbai, Maharashtra, India
3 Independent Researcher, Mumbai, Maharashtra, India
|Date of Submission||03-Sep-2020|
|Date of Decision||22-Jan-2021|
|Date of Acceptance||19-Mar-2021|
|Date of Web Publication||10-May-2021|
Dr. Niharika Gill
Department of Medicine, K. J. Somaiya Hospital and Research Centre, Somaiya Ayurvihar Complex, Eastern Express HWY, Sion East, Mumbai - 400 022, Maharashtra
Source of Support: None, Conflict of Interest: None
In this qualitative prospective survey, usefulness of a mouth-dissolving turmeric lozenge was evaluated among health-care workers (HCWs) directly involved in COVID-19 duty. 303, HCWs serving COVID-19 ward duties received a globally patented mouth-dissolving turmeric lozenge three times daily for 1 month as an additional protective intervention on top of the standard recommended preventive measures. An intervention that can control the portal of entry of the virus and its replication in the oral cavity must be considered for further research to control the pandemic. The preliminary results with this mouth-dissolving turmeric lozenge hold promise for further research in this area.
Keywords: COVID-19, health-care worker protection during COVID-19, India, mouth-dissolving turmeric lozenges, saliva and severe acute respiratory syndrome coronavirus 2 virus
|How to cite this article:|
Gill N, Mestry P, Rajarshi M. Benefits of mouth-dissolving turmeric lozenges among health-care workers: An Indian experience during COVID-19 pandemic. J Patient Saf Infect Control 2020;8:88-91
|How to cite this URL:|
Gill N, Mestry P, Rajarshi M. Benefits of mouth-dissolving turmeric lozenges among health-care workers: An Indian experience during COVID-19 pandemic. J Patient Saf Infect Control [serial online] 2020 [cited 2021 Jul 24];8:88-91. Available from: https://www.jpsiconline.com/text.asp?2020/8/3/88/315743
| Introduction|| |
The accidental contamination of the health-care workers (HCWs) with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is high, and protecting the health-care teams is crucial. Saliva is the prime reservoir for its replication and spread. In this qualitative survey, a mouth-dissolving turmeric lozenge in addition to the recommended infection control and safety measure was evaluated among HCWs. We decided to tackle saliva and selected an intervention with an assumption to reduce the salivary load of pathogen if contracted by the HCWs. The aim of this qualitative survey was to assess the clinical acceptability, tolerance and safety of mouth-dissolving turmeric lozenges among HCWs and to evaluate if it offers any additional protection to HCWs serving COVID-19 duty. The study was registered on the clinical trial portal CTRI/2020/05/025317 and was approved by the ethics committee.
| Methods|| |
KJ Somaiya Medical College and hospital is around 500 bed trust hospital in North-central Mumbai and designated COVID-19 facility. In this survey, all the participants received mouth-dissolving Turmeric lozenge as an additional strategy as a safety precaution in addition to the recommended safety guidelines from national authorities and WHO that also included use of hydroxychloroquine (HCQ).
This mouth-dissolving turmeric lozenge is globally patented and manufactured by M/s Gelnova Labs Pvt. Ltd., Mumbai, Maharashtra, India, and marketed under different brand names (TURMGEL®, TURMNOVA® etc.,) in different markets including few overseas countries.
Informed consent was obtained from each of the HCWs before participating in this survey. The participants had to comply with the eligibility criteria set in the protocol. The participants received lozenge containing 100 mg of turmeric extract three times daily during their duty hours that ranged between 8 and 12 h for the period of 1 month. The duty hours for the HCW wearing personal protective equipment (PPE) are for 8 h in India and were instructed to take 1 lozenge each before donning after doffing of the PPE and 1 lozenge after they reach their place of residence. Participants' general health, vitals including body temperature and presence of any suspected signs and symptoms for COVID-19 were assessed at the baseline and during follow-up visits. The study involved total three visits. The first visit was the baseline and inclusion visit with the follow-up visit at day 15 and end of study visit at day 30.
All the volunteers were screened and clinically examined for the absence of any symptoms related to COVID-19. Should there be any suspicion of COVID-19 in any of the subjects, that subject was planned for further investigated with appropriate swab test for the purposes of diagnosis and confirmation. No subject with any suspicion of COVID-19 was recruited in the study. As the participants were all HCWs and were constantly under supervision for any signs and symptoms of COVID-19. Any slightest suspicion resulted in the withdrawal from attending duties and participation with necessary isolation and investigation. Reverse transcription polymerase chain reaction (RT-PCR) was the only diagnostic confirmatory test considered to determine the positivity.
All the HCWs followed the recommended infection control and protective measures that were prescribed and mandatory while dealing with the COVID-19 patients.
The study protocol included subject withdrawals in case of emergence of suspected signs of COVID-19 as well as confirmation using RT-PCR swab tests.
The evaluation criteria considered clinical acceptability and tolerance of turmeric lozenges in COVID-19 health-care teams. Any serious adverse event (SAE) as well as subject withdrawal due to COVID-19 was considered the part of SAE and complete causality assessment and follow-up until complete resolution was undertaken.
| Results|| |
This survey was conducted during June–July 2020 with 303 eligible HCWs. 294 HCWs completed the survey. Eight participants discontinued the treatment due to mild adverse events, nausea being the most commonly reported. Only 1 nursing staff turned positive 13 days postparticipation in the study with mild symptoms and recovered well. Ninety-seven percent of the participants expressed satisfaction to the treatment and were symptom-free. [Table 1] gives the demography of the participants enrolled in the study. [Figure 1] provides the distribution of designations of the HCWs consisting of doctors, nursing staff, ward personnel, pharmacists and team members from pathology, microbiology, radiology, ambulance teams, etc., clubbed together as others. Weekly HCQ was provided to all the HCWs directly handling the COVID-19 patients.
Among the reported adverse events, nausea was the most common (33%; 3/9 subjects). They were mild and not significant. Investigators opined satisfaction in use of the product for the and expressed no unpleasant experience with the study treatment limiting their daily activities.
| Discussions|| |
The pathogenesis of COVID-19 postulates the involvement of the epithelial oral cavity cells with ample expression of the angiotensin-converting enzyme 2 receptor playing a critical role in allowing SARS-CoV-2 to enter the cells and the oral cavity in the saliva harbouring the replication and shedding of the virus. Saliva, therefore, is being considered an alternative for the detection of viruses with its high transmissible form. Therefore, we considered it as a possible site of action for an intervention that can prevent the entry of the pathogen in the oral cavity for replication and further transmission.
HCW is at direct risk of contracting due to direct exposure and considering additional safety measure for our HCWs was our priority. The choice of intervention was based on the following factors:
- The viral load of COVID-19 is in the saliva and salivary shedding of the virus is responsible for the replication and further spread
- The adhesion of the virus to the mucosal layers is high in the oral cavity, the portal of entry and site of replication
- To choose an intervention capable of action in the oral cavity that can help reduce immediate exposure of the virus by creating a possible barrier for adhesion of the pathogen, the reduce bioburden, replication and prevent further spread of infection,
- To choose an intervention that has barrier forming abilities as well as germicidal activities and with abilities to exert local action in the oral cavity.
Reported use of mouth washes, mouth paints, use of CHX mouth washes and use of salt water gargling in reducing respiratory tract infections were important considerations for our hypothesis as all such interventions have shown benefits in reducing the immediate exposure of the pathogen to the host. We identified a product manufactured and marketed in India containing pure turmeric extract 100 mg as a softgelatine-based mouth dissolving lozenge (pastille) with published human bioavailability data. It takes around 8–10 min for the lozenge to dissolve in the mouth covering the entire mouth-cavity. It is gelatine based with film-forming ability that can presumably be a shield against the adhesion of the pathogen in the oral cavity. Turmeric (botanical name Curcuma longa) has variety of medicinal actions such as antiseptic and immunomodulatory properties. There are several reports of its antiviral activities although direct activity against SARS-CoV-2 is not known, although molecular docking effects of turmeric for SARS-CoV-2 are reported.
Turmeric is a well-known adaptogen and its potential role in immunity is well established. However, for the purposes of this project, evaluation of immunomodulation was not considered, and sero-epidemiological data were not collected.
Our study was a qualitative survey and could be considered as a limitation as we have currently no access to the quantitative measurements of the saliva specimen for estimating viral load as well as the level of curcumin in the saliva. The available PK data of this lozenge are published and have demonstrated its ability to bypass liver to achieve early peak by virtue of buccal absorption; this is suggestive of its solubilisation in saliva and absorption through buccal cavity. The control group was considered in this survey as all possible preventive strategies were necessary to protect every HCW and not providing the potential protective measure had been professionally hazardous as well as morally and ethically wrong.
The viral load of COVID-19 is in the saliva and the study medication turmeric lozenges solubilises in the saliva. Among 294 participants, only 1 subject turned COVID-19 positive. The only positive subject was a nursing staff. She was immediately isolated and treated as per the prescribed treatment protocol by ICMR. The recovery was uneventful. All other HCWs remained free of COVID-19 despite serving duties at the COVID-19 wards. These preliminary results suggest that possibly the mouth-dissolving turmeric lozenge solubised cavity was able to reduce the load of pathogen and thus reduce the chance of contracting infection to almost ~ 99% of the subjects.
| Conclusions|| |
This survey can be considered as the first step towards a potential intervention that can help protect HCWs during COVID-19 pandemic. Further studies are required to evaluate clinical efficacy of this product in COVID-19 using the salivary samples for estimating the viral load among the suspected and confirmed cases as well as its potential benefit in treating asymptomatic patients.
The authors would like to thank the management, Dean and the staff of KJ Somaiya hospital and research centre for all the support provided for the project in these challenging times. The authors acknowledge the help provided by Mr. Sushrut Deshpande for data entry and analysis.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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