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ORIGINAL ARTICLE
Year : 2021  |  Volume : 11  |  Issue : 2  |  Page : 169-173

A Prospective Observational Study of the Outcome of Treatment with Kabasura Kudineer among Patients with SARS-nCOV-2 Infection


1 Department of Pharmacology, Tirunelveli Medical College, Tirunelveli, India
2 Department of Medicine, Government Siddha Medical College, Tirunelveli, India
3 Deparment of Medicine, Tirunelveli Medical College, Tirunelveli, India
4 Tirunelveli Medical College, Tirunelveli, India
5 Government Siddha Medical College, Tirunelveli, India
6 Department of Pathology, Tirunelveli Medical College, Tirunelveli, India

Date of Submission16-Dec-2020
Date of Decision12-Jan-2021
Date of Acceptance16-Feb-2021
Date of Web Publication22-Apr-2021

Correspondence Address:
K. Shantaraman
Head of the Department, Department of Pathology, Tirunelveli Medical College, Tirunelveli
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijnpnd.ijnpnd_113_20

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   Abstract 


Introduction: The novel Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2), has been considered a major life-threatening danger to the human population worldwide. The traditional Indian medicines also play an important role as possible novel therapeutic approaches, exclusively targeting SARS-CoV-2 and its pathways. Among the Siddha medicines, Kabasura kudineer is a formulation composed of 15 ingredients used against fever caused by respiratory infections. Aim: To determine the outcome of Kabasura kudineer, among SARS CoV-2 patients admitted in a tertiary care hospital of Tamil Nadu with mild to moderate symptoms or asymptomatic patients. Methods: A prospective observational study was carried out in Covid care Hospital, Tirunelveli Medical College Hospital, Tirunelveli after the approval of Institutional Ethics Committee. Written informed consent forms were obtained from the patients. A total of 100 patients with positive Real Time Polymerase Chain Reaction (RT-PCR) for SARS-nCov-2 with asymptomatic and mild to moderate symptoms were included in this study. Among them, 50 patients were included in the control group and the other 50 patients were provided with 60 mL Kabasura kudineer for 5 days. Again on the sixth day, RT-PCR was repeated. Results: Among 50 participants in each group, by the sixth day, RT-PCR converted into negative for 27 patients in group B, by 10th day 25 in group A and 22 in group B, by 14th day 25 in group A and remaining 1 in group B became negative. Conclusion: The present study showed Kabasura kudineer was effective when compared with the control group against SARS-nCoV-2 patients with no symptoms and mild symptoms and also the conversion of RT-PCR.

Keywords: Active phytocompounds, botanical, Kabasura Kudineer, RT-PCR, SARS-nCOV-2


How to cite this article:
Ramya JE, Subash Chandran G, Alagesan S, Ravichandran M, Victoria S, Rathi Devi M, Justus Antony S, Shantaraman K. A Prospective Observational Study of the Outcome of Treatment with Kabasura Kudineer among Patients with SARS-nCOV-2 Infection. Int J Nutr Pharmacol Neurol Dis 2021;11:169-73

How to cite this URL:
Ramya JE, Subash Chandran G, Alagesan S, Ravichandran M, Victoria S, Rathi Devi M, Justus Antony S, Shantaraman K. A Prospective Observational Study of the Outcome of Treatment with Kabasura Kudineer among Patients with SARS-nCOV-2 Infection. Int J Nutr Pharmacol Neurol Dis [serial online] 2021 [cited 2021 Jun 12];11:169-73. Available from: https://www.ijnpnd.com/text.asp?2021/11/2/169/314383




   Introduction Top


Coronavirus is characterized as a disease caused by a novel coronavirus now known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly known as 2019-nCoV), which was first detected in a respiratory disease outbreak in Wuhan City, Hubei Province, China.[1] It was initially reported to the World Health Organization (WHO) on Dec 31, 2019. On January 30, 2020, the WHO declared the outbreak of COVID-19 a global health emergency.[2],[3] On March 11, 2020, the WHO announced COVID-19 a global pandemic, its first such designation since reporting a 2009 pandemic of H1N1 influenza.[4]

Coronaviruses (CoVs) are the largest group of viruses belonging to the family Coronaviridae and the order Nidovirales.[5],[6] They are either pleomorphic or spherical with a diameter of 125 nm.[7],[8] Further they are characterized by club-shaped spike projections on their surface. Respiratory droplets mainly cause transmission of COVID-19, by direct human to human contact. Fecal to oral communication might also be associated. COVID-19 prominently affects the respiratory tract (both lower and upper respiratory tract), with the initial symptoms of common cold, fever, dry cough, fatigue, nasal congestion, sore throat, and diarrhea to severe pneumonia, difficulty in breathing, and ends with the patient death.[9] The incubation period of the disease is 14 days and the time from onset of symptom to developing pneumonia is 4 days.[10] The statistical data of COVID in Tamil Nadu was 46,495 new confirmed cases and 8871 deaths as of September 21, 2020 and 1281 positive cases in Tirunelveli Medical College hospitals.[11]

Presently, quarantine and symptomatic treatment protocol for disease management play a major role in the treatment of COVID-19. Currently, for management of COVID-19, there are many drugs that are getting repurposed for the same such as antivirals, antimalarials, antibiotics, antiparasitics, and monoclonal antibodies. Drug development is a consuming process in terms of time, cost, humans, and molecular techniques. Traditional herbal medicines have been used in the past to control and treat many epidemic outbreaks including diseases such as SARS and H1N1 influenza.[12] Recently, China and South Korea have issued traditional medicinal treatment guidelines on the prevention and treatment of COVID-19.[13] It has been reported that more than 85% of Covid-19 infected patients in China had also received some forms of traditional Chinese medicine treatments.

Our Indian traditional medicinal systems are considered one of the oldest treatments in human history and also play a very important role in confronting global health care needs. Traditional Indian medicine includes Siddha, Ayurveda, Unani, Naturopathy and homeopathy, and Yoga. Besides, during the Dengue outbreak in India, a herbal formulation of Siddha medicine, Nilavembu Kudineer, was used to prevent and control the morbidity level of the public on contacting this viral fever.[14] Kabasura Kudineer, a Siddha formulation described in Siddha manuscript “Citta Vaittiyattirattu,” is used for Aiyacuram (phlegmatic fevers) and is a dependable Siddha prescription for fever with flu-like symptom.[15] According to the guidelines for Siddha practitioners for Covid-19, Kaba Sura Kudineer 60 mL twice a day after food, NilaVembu Kudineer 60 mL twice a day after food, Visha Sura Kudineer 60 mL twice a day after food, Pavala Parpam 100 mg twice a day with honey, Velli parpam 50 to 100 mg twice a day with honey. Kabasura kudineer chooranam is widely used in Siddha for the treatment of fevers and also as a prophylactic at the time of viral epidemics.[16] The aim of this study is to determine the effectiveness of Kabasurakudineer among SARS CoV-2 patients admitted in a tertiary care hospital of Tamil Nadu with mild to moderate symptoms or asymptomatic patients.


   Materials and Methods Top


The study design was prospective study conducted in Covid care center in Tirunelveli Medical College Hospital in-patient ward and was conducted for a period of 2 months during May and June 2020.

Inclusion criteria

  1. Subjects who were equal to or greater than 18 years of age,
  2. Subjects who were tested positive for COVID-19 RT-PCR declared by ICMR-approved laboratory with no symptoms or mild symptoms.


Exclusion criteria

  1. Subjects who were considered as high-risk groups such as patients with Diabetes mellitus, hypertension, heart diseases, cancer, and multi-organ failure syndrome (MODS).
  2. Pregnant and nursing women
  3. Subjects with severe symptoms of Covid-19 as per “National Guideline on clinical management of coronavirus disease 2019 (COVID-19) version 7.0” were excluded in this study.


The study was conducted after receiving the approval from Institutional Ethical Committee approval no-1785 dated April 30, 2020. After centuries, the outbreak of SARS-nCoV-2 virus that was a new strain that has not been previously identified in humans and also considering the pandemic situation, we recruited 100 participants in total using a convenient sampling technique. During the period of May to June 2020, the total number of cases admitted with positive RT-PCR was 851 in the covid care unit. Among those mild to moderate symptomatic and asymptomatic patients were 550 and after exclusion of patients with comorbid conditions, there were 349 patients. We included 100 patients who were fulfilling all the criteria and gave consent, and divided 50 participants into each group by simple randomization.

The 100 patients who fulfilled the criteria were then grouped into groups A and B.
  1. Group A − control group − 50 patients
  2. Group B − Kabasurakudineer group − 50 patients


Group A was treated with Vitamin C (60,000 IU) and Zinc tablets (100 mg) orally twice daily for 14 days.

The Siddha classical Kabasurakudineer chooranam has 15 ingredients as described in [Table 1].
Table 1 Ingredients of Kabasura kudineer

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The patients’ willingness was obtained through telephonic consent considering this pandemic situation. The purpose of the trial was explained to all eligible participants willing to participate in the trial and also explained about the voluntary participation and he/she is free to withdraw from the study in between any time without any justifications. In this study age (decade) and sex related matching was done for both the groups A and B.

Criteria screening, clinical history, complaints and duration, examination findings, and Investigation findings were recorded in the prescribed proforma. qRT-PCR was repeated on days 6, 10, and 14 from the start of intervention along with the standard regimen. Patients were administered with Kabasura kudineer 60 mL twice a day before food for 5 days. Patients of both groups were given symptomatic treatment with analgesics, antipyretics, and antitussives whenever needed. During the study, no participants were treated concomitantly with immune therapy or any antiviral therapy, and the possibility of confounders was minimized during the course of treatment. There was no loss to follow up as all the study participants were hospitalized and quarantined, discharged only after the conversion of RT-PCR to negative. All patients were ensured about the drug intake.

Data analysis

The data were collected using proforma and tabulated in MS excel and the analysis was performed using SPSS version 12.0. continuous data were analyzed using Student t-test, and categorical data were analyzed using the Pearson chi-square test.


   Results Top


A total of 50 patients who tested positive for RT-PCR COVID-19 were selected for the study. [Table 2] and [Table 3] shows the basic socio-demographic characteristics of the participants. The mean age of the study participants was 35.5 years for group A and 36 years for group B. According to the age distribution of study participants, shows the following: age 19 to 40 years (64% in group A and 68% in group B), 41 to 60 years (15% in group A and 28% in group B), and >60 years (6% in group A and 4% in group B). Among the study participants (n = 100), 31 were male in each group (62%) and 19 were female in each group (38%). Also, among these 100 participants, 33 (66%) in group A and 39 (78%) in group B were asymptomatic and 17 (34%) in group A and 11 (22%) in group B were symptomatic.
Table 2 Basic socio-demographic profile (n = 100)

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Table 3 Laboratory reports of Groups A and B (independent sample t test)

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[Table 3] shows the basic blood parameters among the study participants of both control group and kabasurakudineer group. On comparing both the groups RBS, urea, LDH, and ALP reports showed significant P-values that were 0.016, 0.000, 0.000, and 0.000, respectively. Other blood parameters were not significant.

[Figure 1] shows a comparison of conversion of RT-PCR of both the groups that shows in group B, 82% of patients became negative by 10th day and remaining 18% became negative by 14th day, whereas in the control group, all the participants became negative only by 14th day and the P-value was 0.000.
Figure 1 Comparision of conversion of RT-PCR on 10th and 14th day

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[Table 4] shows a comparison of conversion of RT-PCR of both the groups classifying in according to the illness. This shows that the number of asymptomatic and mild symptomatic patients in both Groups A and B. Few adverse effects such as vomiting, diarrhea, and gastritis were seen in group B that were only mild for which the patient was not withdrawn from the study.
Table 4 Comparision of RT-PCR of the 6th, 10th, and 14th day test reports.

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   Discussion Top


The search for very effective drugs with anti-viral treatment against COVID-19 has lead the world to repurpose and look into all the available drugs with antiviral properties and may be effective in killing this novel coronavirus. At present, the cornerstone of therapy for treating patients with COVID-19 remains supportive care. Beyond these treatments, adjunctive therapies such as corticosteroids, anti-cytokine or immunomodulatory agents, and immunoglobulin therapy also play an important role. Hence, boosting up our immunity plays a vital role in treating this novel coronavirus. In the case of Siddha medicine, herbs such as Amukkara and Nilavembu are immune-modulators and have the capacity to inhibit the virus by enhancing and restoring the immunity of humans. So, we are utilizing this strength of Siddha medicine to arrive upon a potent formulation that is both antiviral and immuno-modulatory with minimum side effects on patients who are immunocompromised as well as those who have comorbid conditions. The Kabasura kudineer increases the immunity and could act as an immunomodulator as this virus is adversely affecting the immune response by changing the signaling pathway of TNF production as recent findings shows. The formulation chosen is aimed at increasing immunity and also to expel out the Kapham and reinstate respiratory health. Drugs in these formulations majorly possess bitter taste or pungent taste. These drugs on postdigestive transformation get converted to hot potency, which increases and normalizes Pitham and expels out excessive Kapham out of lungs, which is the rationale behind selecting these formulations. Andrographis paniculate has bitter taste and hot potency that help in all fevers by precipitating diaphoresis,[16] in Dengue outbreak and during other disaster mitigation interventions, it was the drug of choice even by public health authorities. By possessing anti-inflammatory, analgesic, antipyretic, and immunomodulatory activity,[17],[18] this has also proven to inhibit Dengue virus.[19]

In this study, 50 patients were under the control group and the other 50 patients were given Kabasura kudineer. The majority were males (62%) in both the groups and the mean age was 35.5 years for group A and 36 years for group B. Also in this study, asymptomatic patients were 78% and only 22% were symptomatic that was inconsistent with Rahuman et al.[19] study. Viral clearance was 82% in group B, whereas there was no clearance in group A and the remaining 18% in group B within 14th day, and 100% clearance was seen in group A that showed that Kabasura kudineer group had earlier viral clearance than the control group and also the P-value was significant. No major adverse effects were observed in this Kabasura kudineer group than minor overlapping symptoms such as vomiting, diarrhea, and gastritis. This study is a new study and so far there is no definite study found on human beings affecting viral clearance of Covid-19. Further studies are to be needed for earlier viral clearance of covid patients and keeping consideration of individual safety, the exact dose, and frequency that will be absolutely beneficial for viral clearance of covid-19 on human beings need to be determined in future by further control study.

Limitations

The limitation of the study is that the study has been conducted for a shorter period of time and with a limited number of patients. Also in this study, we excluded comorbid condition.


   Conclusion Top


The current study demonstrated the efficacy of Kabasura kudineer against SARS-CoV-2 diseases. The results are clinically significant in a small group of population. Thus, this study shows that Kabasura kudineer is safe and also effective in the early conversion of RT-PCR in COVID-19 patients.

Implications

The Kabasura kudineer can be included as an adjuvant in the treatment regimen of COVID patients to boost their immunity.

Acknowledgements

The authors are grateful to Tirunelveli Medical college for supporting the study. We also thank all the participants for their unbiased voluntary participation.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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    Figures

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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