Assessment and Efficacy of Siddha Treatment in COVID 19 SARS-CoV-2: A Case Series

Aims: To evaluate clinical validation, safety assessment and efficacy of Siddha line of treatment in COVID-19 patients. Presentation of the Case: Open labelled, interventional, prospective cohort study conducted in Covid ward, Kokila Siddha Hospital and Research Centre, Madurai between June and Aug 2021. Among 22 registered in the trial 5 (22.72%) developed breathing difficulty, treated with oxygen support, 10 (45.5%) were male, 12 (54.5%) were female. At the time of admission, maximum 9 (40.9 %) had fever, followed by dry cough 18 (81.8%), dyspnea 8 (36.4%), malaise 16 (72.7%), anorexia 8 (36.4%), headache 4 (18.2%), Type-2DM 5 (23%), and 2 (9%) had hypertension as comorbidity. Hematology, LFT, RFT, D-Dimer, PTT, CRP were taken before and after 5 days of treatment. Discussion: The mean hospital stay was 7 days and discharged on a minimum of 4th day and a maximum of 16 th day. The mean hospital stay for hypoxic patients was 10 days. Paired sample test Case Study Jeyavenkatesh et al.; JPRI, 33(60B): 131-141, 2021; Article no.JPRI.80869 132 analysis has been carried out to find a significant difference in the counts of lymphocytes, ESR, CRP and PTT after the administration of the intervention. Conclusion: The medications chosen according to the pathology of Kaba suram and administered starting on first day of admission, depending on the stage and severity of the infection. Patients were provided with appropriate food, exercise, therapy in conjunction with medications and found the patient's condition has not deteriorated further. It is reasonable to conclude that the treatment of COVID-19 with selective Siddha medications stopped the disease progress more critical.


INTRODUCTION
SARS CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) infection became a global public health threat and had a large economic impact. Since December 2019, when the coronavirus infection 2019 (COVID-19) was found, approximately 100 million confirmed cases and 2 million deaths have been reported worldwide [1]. However, the majority of individuals with COVID19 experience mild to moderate symptoms, and only approximately 10-15 percent develop severe illness [2,3]. There are currently no medications available due to the virus's novelty and broad clinical reach. In the absence of viable treatments, traditional remedies were used as an integrated treatment for COVID-19, as they had been for other infectious diseases in the past [4].
Traditional Indian medicines include Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy (AYUSH). The Siddha system of medicine is largely practised in India's southern states and Tamil-speaking countries around the world [5]. The Ministry of AYUSH of India has provided therapeutic instructions for AYUSH practitioners to prevent and manage COVID-19, including the use of Kabasura Kudineer (KSK), a polyherbal Siddha formulation [6,7].
Siddha literatures describe 64 types of fever under Suram (pyrexia/fever). According to Siddha philosophy, Vatham is responsible for conception and creation, Pitham humour is responsible for disease prevention, and Kabam is responsible for destruction, as stated in the verses of Siddhar Theran: "Vaathamai padaithu pitha vanniyai kaathu sethuma seethamai thudaithu" [8]. Suram is characterised according to the impacted Mukkuttram (Vatham, Pitham, and Kabam), the associated unhealthy food and lifestyle. Kaba Suram is believed to occur as a result of kabam's exacerbated humour being far stronger than normal, creating an ideal habitat for any respiratory infection [9,10]. Its [12]. The increase in Kaba humour causes Thondai nothal (sore throat), Irumal (cough), and Kozhai kakkal (expectoration), which are likewise symptoms of COVID-19's basic stage [13]. Diarrhoea arises as a result of a weakened protective immune response, allowing infection to enter, particularly in organs with high Angiotensin-converting enzyme 2 genes (ACE2) expression. This induces diarrhoea by causing inflammation in the digestive tract [14]. This data reinforces the Siddha pathophysiological idea of kaba humour aggravation in the colon (Kudal thannil seetham), which is the primary cause of fever and disease progression. This stage is similar to the symptoms of an increase in Kabam in the chest area causing Moochu thinaral (Dyspnoea), Mael moochu, Oon kollaamai (loss of appetite), Thookkaminmai (Insomnia), and Kalaithu pothal (weariness) as described in the scriptures Suravaagadam and Theran karisal.

Stage II
This severe stage of COVID-19 can be well correlated with the persistent severe increase of Kabam in the chest area, resulting in Mael moochu (Severe dyspnoea), Naakku mugam veluthal (Pallor of tongue and face) as indicated in the text Yugimunivar vaithya chintamani, viyarvai (profuse sweat), udal veenkuthal (Anasarca). Due to a high body temperature, viyarvai (prolific sweating) can occur [15]. Hypercapnia can cause a reduction in carbon dioxide diffusion, resulting in increased perspiration and vasodilation [16]. Pallor of the tongue and face, as indicated in Siddha writings, could be caused by ARDS, which is characterised by inadequate oxygenation resulting in hypoxia and can also manifest as central or peripheral cyanosis as a result of hypoxia. As indicated in Theran Karisal, udal veenguthal (Anasarca) can arise as a result of pulmonary oedema, renal dysfunction, and decreased output [17].

Stage III
Sanni (Delirious stage) has been described in Siddha writings as the final stage of Kaba suram (Covid 19) because of the dramatic release of proinflammatory mediators. Acham, Manavetrumai (Emotional disturbances of fear and depression), Athatti pesuthal, Vaay Kularal (Irrelevant speech, agitation) and Thannilai ariyaamai (Impaired consciousness) are all symptoms of, kaba suram which affects the three humours Vatham, Pitham and Kabam, which are responsible for the well-being of an individual. Even while hiccups (Vikkal) appear to be an insignificant symptom, they may be the most common sign of pneumonia [18]. Symptoms such as Naachuvai ariyaamai (loss of smell/altered taste), vaay thuvarthal, kadhu iraidhal and kadhu kaelamai (Auditory deficits) are described in detail in the Siddha literature on Kaba Suram.

AIM AND OBJECTIVE
To evaluate clinical validation, safety assessment and efficacy of Siddha line of treatment in COVID-19 patients.

Study Type
Interventional, prospective cohort study

Masking
Open labelled

Selection Criteria
The patients experience mild to moderate symptoms such as fever, body ache, dry cough, throat soreness, dizziness, etc, those who tested RT-PCR positive for COVID-19 came for admission in Covid ward, Kokila Siddha hospital and research centre, Madurai and were willing to engage in the study were chosen for the current study.

Inclusion Criteria
 All patients included in this study were diagnosed COVID-19 based on the World Health Organization (WHO) guidelines those who had an influenza-like illness and were SARS-CoV-2 Reverse transcriptionpolymerase chain reaction (RT-PCR) positive in a throat swab.  Both male and female  Patients belonging to age 12 years and above  Patients who are willing to take Siddha medication

Exclusion Criteria
 Patients with high-grade (103°F (39.4°C) or above) fever  Patients with age below 12 years  SPO2 < 92%  Chest pain or discomfort on deep breath  Difficulty in breathing  Patients having uncontrolled HT or DM, Bronchial asthma, CKD or liver diseases.  Patients who require intensive care/ventilator

Vazhalai Vaanguthal (Expectoration)
Vazhalai Vaanguthal (expectoration) can be performed in the morning after brushing the teeth. It is accomplished through the use of Karisalai Nei. Karisalai nei is made by combining equal amounts of leaf juice from Manjal karisalai (Wedelia calendulacea) with cow's ghee in a mixing bowl and boiling until smooth. For 12 repetitions or until the phlegm has been expelled, apply 1-2 gram on the thumb finger and insert, smear, and rotate on the upper soft palate, softly touching the uvula [18]. It is done 1-3 times a day for three days. The phlegm that has gathered is spit out to prevent and remove virus development. For the first three days, it is usually done here early in the morning. The administration of this therapy, on the other hand, will be determined following the patient's health status.

Vedhu and Otrada pottani (Inhalation and Fomentation)
Vedhu is process of steam inhalation after boiling the leaves of the notchi plant (Vitex negundo). It is done in about 3-5 days. Further the leaves are rolled into an otrada pottanam (bundle fomentation) and applied to the chest and back to relieve chest congestion and prevent it from occurring [19]. It is performed once or twice a day for seven days, depending on the severity of the congestion in the lungs.

Diet and Drug Regimen
The following

Internal Medicine
The treatment protocol for the patients includes primary and secondary drugs. The primary drug ( The ingredients and manufacturer of the drugs those used in the study (Table 4).

Laboratory Investigations
The laboratory investigations like haematology, liver function test, renal function test, D-Dimer, PTT, CRP were taken before discharge to assess the prognosis.

A 6-minute Walk Test
A 6-minute walk test is a simple clinical examination that has been used for many years to assess cardiopulmonary exercise tolerance. This test is used to uncover hypoxia that has been concealed. A pulse oximeter is affixed to the patient's finger, and he is instructed to walk about the boundaries of his room for 6 minutes constantly. The slight decrease in saturation below 94 per cent, or an absolute decrease of more than 3 per cent to 5 per cent, or the sensation of being uncomfortable (lightheaded, short of breath) while doing the test or after six minutes are all considered significant findings in this study. These patients are labelled as positive for the 6-minute walk test.
Assessment of general health condition, laboratory investigations, 6-minute walk test are done for all the patients before discharge.  At the time of admission, the mean and median systolic pressure was 128 and 130 respectively which ranges between 90 to 170mg/dl. The mean and median diastolic pressure was 70 and 80 respectively which ranges between 60 to 100mg/dl (Fig. 3).

OBSERVATION
Hematology, LFT, RFT, D-Dimer, PTT, CRP were taken before and after 5 days of treatment. The mean hospital stay was 7 days. The patients were discharged on a minimum of 4th day and a maximum of 16 th day. The mean hospital stay for hypoxic patients was 10 days. Paired sample test analysis has been carried out to find a significant difference in the counts of lymphocytes, ESR, CRP and PTT after the administration of the intervention.
This study revealed that it is reasonable to conclude that the treatment of COVID-19 with the Siddha medications prescribed stopped the disease from progressing to a more critical stage.

*[The black boxes denote the vanish of symptoms and the numbers in the white box denote the number of cases
showed symptoms]

CONCLUSION
The pathology of Kaba suram has been described stage by stage in this study, in accordance with the Siddha literature, and the results that have been previously published. The illness has been traced back to its source (Noi mudhal naadal) and the infection diagnosis. has been made of the infection. The medications have been carefully chosen and administered to patients in the first day of admission, depending on the stage and severity of the infection. Patients were also provided with appropriate food, exercise, and external therapy as needed in conjunction with their medications. It has been seen that the patient's condition has not deteriorated further. Without using synthetic steroids and with optimum oxygen support, this case report emphasises the therapeutic success of administering herbal and herbomineral Siddha formulations as a supplementary when required in the early inflammatory phase of COVID-19 infection and hypoxic situation. As a result, it is reasonable to conclude that the treatment of COVID-19 with the Siddha medications prescribed stopped the disease from progressing to a more critical stage. Even though with patient who had a severe cough and a fever higher than 39.1 ° Celsius, the patient did not worsen or become breathless. India utilises the vast amount of knowledge contained within the Indian Systems of Medicine to heal this sickness and bring the epidemic under control. The opportunity to demonstrate the efficacy of Siddha is also extremely valuable at this stage and also further investigations are needed to provide more scientific evidence.

DISCLAIMER
The products used for this research are commonly and predominantly use products in our area of research and country. There is absolutely no conflict of interest between the authors and producers of the products because we do not intend to use these products as an avenue for any litigation but for the advancement of knowledge. Also, the research was not funded by the producing company rather it was funded by personal efforts of the authors.

CONSENT
All authors declare that a written informed consent was obtained from the patient or other approved parties for publication of this case report and accompanying images. A copy of the written consent is available for review.

ETHICAL APROVAL
The trial has received approval from Institutional Ethical Committee of Kokila Siddha Hospital and Research Centre. The trial is registered in Clinical Trial Registry of India and the registration number is CTRI/2021/06/034145.

NOTE
The study highlights the efficacy of "Siddha" which is an ancient tradition, used in some parts of India. This ancient concept should be carefully evaluated in the light of modern medical science and can be utilized partially if found suitable.