HPTLC and GC-MS finger-printing of two potential multifunctional siddha tailams: Mathan and maha megarajanga tailam.

The Siddha system of medicine is an ancient medical lineage that is practiced primarily in the southern part of India. Siddha system of medicine has been in practice for thousands of years with documented evidence dating back to the 6th century BCE. According to siddha system of medicine's basic fundamental principle, the human body is made up of 96 thathuvam (primary components), which encompass physical, physiological, psychological, and intellectual aspects. Medicine (marunthu) is classified as a wide range of internal and external medicines. The major components of its medical formulations include plant parts, minerals and animal products. Various methods were carried out for the purification process to eliminate the toxins. Choornam, Guligai, Tailam, Parpam, Chendooram, Kattu, Pasai and Poochu are the most common medicines used in Siddha system of medicine for the treatment of various diseases. The pathophysiological classification of diseases is elaborated in detail in the classical Siddha literature. Siddha system of medicine plays an important role in protecting people from diseases such as COVID-19 by providing immune-protecting and immune-boosting medicines in today's world. Mathan tailam and maha megarajanga tailam are the two unique preparations used widely for various skin diseases including chronic wounds and burns. Scientific validation of both medicines will help in understanding their effectiveness against a typical wound condition. In the present study physio-chemical and phytochemical, HPTLC, and GC-MS analyses were carried out and discussed in detail on the multifunctional properties exhibited in the patient communities.

Indian Traditional Medicine for COVID-19

Background: A novel coronavirus COVID-19 outbreak causing infectious respiratory disorders. COVID-19 disease has no specific treatment. In traditional medicinal system, different formulations are available for infectious diseases. Objective(s): This review discusses the significance and utilization of Siddha and Ayurvedic herbal formulations for COVID-19 treatment and provides scientific information regarding the phytochem-istry and pharmacological profiles of Indian medicinal plants used in the formulation. Method(s): The information on medicine and medicinal plants was collected from research papers, review papers, and books available in several electronic databases, including Google Scholar, SpringerLink, and PubMed was explored as information sources. Result(s): Traditional medicinal plants are potentially used in formulations due to their inevitable therapeutic properties. Phytochemistry and pharmacological properties of medicinal plants used in the formulations served as scientific proof for traditional medicine. Conclusion(s): The present study explored the great importance of Siddha and Ayurvedic formulations for COVID-19 treatment. Further scientific investigations are required to explore these formulations as widely acceptable.Copyright © 2023 Bentham Science Publishers.

Simultaneous Quantification of Piperine, Vasicine and Eugenol in Kabasura Kudineer by HPTLC

Kabasura Kudineer is a polyherbal decoction of the Siddha medical system (an Indian system of medicine), traditionally used to cure fever, colds, coughs, and respiratory ailments. The government of India had recommended Kabasura Kudineer as one of many preventive/treatment measures for COVID-19. Kabasura Kudineer Choornam is an admixed coarse powder of 15 herbs and its decoction is Kabasura Kudineer. The chemical constituents in the 15 herbs used for the preparation of the Choornam are known but the constituents present in the Kabasura Kudineer (decoction) are unidentified. Piperine, vasicine and eugenol are known for their potent activity against respiratory tract infections;hence, they were selected as marker compounds. The present work was planned to simultaneously quantify piperine, vasicine and eugenol in Kabasura Kudineer by the HPTLC method. The optimised mobile phase was toluene: ethyl acetate: methanol: ammonia (5:9:3:0.5, v/v/v/v), and the scanning was carried out at 287 nm. The Rf values of piperine, vasicine and eugenol were found to be 0.70, 0.32 and 0.82, respectively. The linearity range of piperine and vasicine was 500-3000 ng spot-1 and it was 10-60 ng spot-1 for eugenol. The quantities of piperine, vasicine and eugenol in Kabasura Kudineer (100 mL) were 0.03, 0.056 and 0.035 % w/v, respectively. This developed method can be used to simultaneously quantify piperine, vasicine and eugenol in any polyherbal formulation.Copyright © 2023, Informatics Publishing Limited and Society for Biocontrol Advancement. All rights reserved.

Overview of COVID-19 Pandemic: Its Management and Prevention in Light of the Indian Traditional Medicine System

With the global death toll nearing 3.3 million, India being amongst the top 4 countries, the condition is more than fearsome. World Health Organization (WHO) recommends one doctor per 1000 population ratio, but India lags it by one doctor to 1456 people, which sets a lot of pressure on the healthcare system. Traditional remedies are becoming increasingly popular in India as a re-sult of the lack of a proper medical system. Due to the rich diversity of medicinal herbs and drugs, India has been managing health issues with its 5000 years old medication system. Amidst all this, the traditional medicine system has given relief to plenty of diseases and remains the primary de-fence system against COVID-19. Therefore, COVID-19 is also managed by its different medicinal systems, which are collectively known as the AYUSH regime. It had been a recognized system to tackle diseases in the past. In this mini-review, we performed a deep study of the Indian traditional medicine system in managing the COVID-19 situation.Copyright © 2023 Bentham Science Publishers.

Perception and Preference towards Siddha Medicines during Covid-19 in Tamil Nadu

The COVID-19 outbreak caused a huge loss of life, both for the victims and their families. It brought to a financial catastrophe that had unanticipatedly large proportions globally and ruined livelihoods. The Indian government has collaborated with the Ministry of Ayush to establish a number of policies and preventative actions to combat the COVID-19 epidemic. Patients have benefited from the use of these strategies in conquering the early stages of Corona virus infection. In light of COVID-19, the researcher is interested in learning how the general public in Tamil Nadu thinks about and favours Ayurvedic medicines. The researcher also wanted to know the respondents' preferences for the Ayurvedic medications they frequently used to treat different conditions. The results of the study were widely publicized throughout Tamil Nadu. The convenience sampling technique was used to gather the samples from the study area. The sample included 390 respondents. The research model was framed by the variables perception, usage, preference, and satisfaction. Four hypotheses were presented for this investigation. Primary data was acquired using a well-structured questionnaire. Variables pertaining to perception, usage, preference, and satisfaction were included in the questionnaire. This shows that consumption serves as a mediating variable in the relationship between consumer perception and desire for Ayurvedic medicines. Preference perception is significant at a level of 0.05. The research methodology and assumptions were tested and determined to be true, yet there is no significant relationship between utilisation and satisfaction. Copyright © 2023 Wolters Kluwer Medknow Publications. All rights reserved.

Health-related quality of life and associated factors among COVID-19 individuals managed with indian traditional medicine: A cross-sectional study from south India.

Introduction: Coronavirus disease-2019 (COVID-19) had a multidimensional impact on human life. It affects the health-related quality of life (HRQoL) which is a perceived measure of physical and mental health. We estimated the EuroQol utility value for COVID-19 and the associated factors for those managed at Siddha COVID care centres in Tamil Nadu. Methods: A cross-sectional study was conducted by a telephonic interview of 2000 randomly selected COVID-19 adults tested positive during June 2020 to Jan 2021. We collected sociodemographic, clinical and EQ-5D-5L profile. Mean EQ-5D-5L summary utility values and EQ-VAS scores were estimated. Multivariate regression was used to examine the factors associated with EQ-5D-5L. Study protocol was approved by the Institutional ethics committee of Government Siddha Medical College, Chennai (GSMC-CH-3401/ME-2/050/2021). The committee waived the written informed consent considering the pandemic situation of emerging infectious diseases. Results: We interviewed 1047 participants. Of the total 68% were males with the median age (IQR) of 38 (29-51) years. The mean EQ-5D-5L utility score and EQ-VAS scores are 0.98 ± 0.05 and 92.14 ± 0.39 respectively. COVID-19 asymptomatic group reported a mean utility score of 0.99 ± 0.03 which is relatively more than the symptomatic group (0.97 ± 0.06),. EQ-VAS score was also reported high among the asymptomatic (95.45 ± 5.95) than the symptomatic (91.40 ± 8.69COVID-19. Conclusion: The severity of illness and the comorbidity are significantly associated with a low HRQoL of COVID-19 patients.

Retrospective time to event analysis of integrated medicine treatment effect on mild symptomatic COVID19 patients in facility quarantine at Kallakurichi, Tamil Nadu

Background: This study has been conducted on confirmed COVID 19 positive patients (n = 55), who had come to Kallakurichi District of Tamilnadu state from one of the containment zones in Indian State of Maharashtra. Out of the 55, 8 (14.55%) patients were symptomatic and remaining 47 (85.45%) were asymptomatic patients. 47 patients who reached in their home land on 24th May and rest on 25th may 2020. All of them have been treated with integrated medicine treatment method. Materials and Methods: Everybody was quarantined from 27th may to 7th June 2020 at Mahabharathi Engineering College, Vasudevanur, Chinna salem Taluk, Kallakurichi District. Integrative Intervention Consisting of Vitamin C Tablet, Zinc tablet for 5 days, and Kabasura Kudineer 60 ml BD Before food for all days was the treatment given for all patients. Result: Among them, three of them had co -morbid conditions like diabetes and hypertension. 27.3% were female and 72.7% are male patients. Average age was 32.33 among the range of 14 to 65years. Conclusion: All patients including who has co-morbidity were completely relieved from the disease on the day of discharge. All symptomatic patients were asymptomatic with median time of 4 days IP admission.

Therapeutic Efficacy of Polyherbal Formulation Kabasura kudineer Against Common Viral Fevers-A Perspective Review

Background: COVID-19 viral infection is a worldwide pandemic that created a major concern regarding the need for a suitable drug candidate for viral infections. The entire scientific community is putting up their efforts and research to find a proper cure for this. The traditional Indian Siddha system of medicine is one of the oldest forms of medicine, which includes medicine, Varma, alchemy, yoga, and rejuvenation. Method(s): Kabasura kudineer is one of the Siddha herbal preparations that are being recommended by the State government of Tamilnadu, India, for protection against COVID-19. It is recommended due to its claims to have anti-viral properties and other numerous health benefits. Result(s): This article thoroughly examines the Kabasura kudineer, a polyherbal formulation comprising 15 powerful ancient Indian herbals that possess various potential phytochemicals providing numerous therapeutic activities. Also, the review highlights the most important therapeutic benefits of this formulation like anti-viral properties along with other activities such as im-munomodulatory, bronchodilatory, anti-asthmatic, etc., Conclusion(s): The role of Kabasura kudineer against viral diseases, especially the recent COVID-19, is tremendous, and there is a need to enhance further research on this powerful formulation to make it more efficient and useful to the entire people community. Copyright © 2022 Bentham Science Publishers.

Safety and efficacy of a Siddha Medicine fixed regimen for the treatment of asymptomatic and mild COVID-19 patients.

Background: The Coronavirus disease 2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a massive threat to public health worldwide. Siddha system of medicine is one of the traditional medicines of South India. The recommended formulations in Siddha Sasthric Medicines- Fixed Regimen (SSM-FiRe) are Amukkura tablets, Kaba Sura Kudineer (KSK) for asymptomatic COVID-19 positive (RT-PCR) patients, and Athimathuram tablets, Adathodai Manappagu syrup, Thippili Rasayanam, Brahmananda Bairavam tablet, and Notchi Kudineer for mild symptomatic patients. The core objective of the trial was to document the efficacy of SSM-FiRe in the prevention of asymptomatic and mild COVID-19 disease progression to the next level of severity, reduce the severity of symptoms and revert to RT-PCR Negative. Methods: An exploratory, prospective, open-labeled, single-arm, non-randomized trial was designed as per GCP guidelines to assess the efficacy of SSM-FiRe. Sixty RT-PCR positive participants who were asymptomatic or with mild COVID-19 symptoms were recruited for the study at the Siddha COVID Care Centre, Vyasarpadi, Chennai from June to August 2020. Nasal and oropharyngeal swab tests were performed on the 0, 7th, and 14th days. All participants were treated with SSM - FiRe regimen. All the participants were also assessed based on Siddha Yakkkaiyin Ilakkanam, which included Clinical symptoms and vitals. Laboratory investigations such as Haemogram, Liver Function Test, Renal Function Test, HbA1C, Electrolytes, Inflammatory markers, Cardiac profile, Immunoglobulins, and anti-SARS-CoV-2 antibody tests were performed. Results: 83% of COVID-19 patients turned RT-PCR negative on the 7th day and in most of the cases, symptoms were reduced within the first 5 days of admission. The RT-PCR cycle threshold (ct) value increased significantly (<0.001) after treatment and all the participants were RT-PCR negative, except one, who was positive even after 14 days. Anti-SARS-CoV-2 antibodies developed significantly (p-value - 0.006). LFT, RFT, CBC, Total proteins, and electrolytes continued to be in the normal range after treatment, indicating the safety of the intervention. Conclusion: Asymptomatic and mild COVID-19 disease can be well managed by SSM - FiRe treatment, Further studies could be taken up to strengthen the findings.

A Review of Herbal Regulations in India and Worldwide

This review highlights the regulatory status of herbal medicines in India and in specific countries. The herbal medicines are being used in different system of medicines like the Ayurveda, siddha, homeopathy, unani and Chinese system of medicine. The regulatory authorities and WHO are making efforts to collaborate in order to for a harmonized herbal medicine regulation. The Drugs and Cosmetics Act 1940 and Rules 1945 consist of the regulatory guidance and guidelines for Ayurveda, Unani, Siddha medicine. The herbal medicines are being categorized as Complimentary medicines, Natural health products, Prescription medicines, over the counter medicines, Supplements, Traditional herbal medicines globally.

Anti-Obesity Siddha Medicinal Plants-A Preclinical Review

Obesity is a complex multi factorial preventable disease affecting all age groups of both the sexes. Now one third of world’s population is overweight or obese. From 1980 the world-wide prevalence of obesity has become doubled. Overweight and obesity were the 5th foremost causes of death globally. Obesity is associated with many co morbid diseases. Prevalence of obesity with co morbidities is on big alarm throughout the world. Recently in COVID-19 pandemic most of the obese people get affected due to the co morbidities and reduced immunity. The anti-obesity properties of medicinal plants were known from ancient times in traditional Siddha medicine some thousand years ago. Many Siddha medicinal plants showed anti-obesity activities that can be utilized in the management of obesity, through which the complications of obesity can be prevented. Most researches explored the anti-obesity potentials of medicinal plants. Terminalia chebula, Phyllanthus niruri, zingiber officinale, Piper longum, Curcuma longa, Elettaria cardamomum, Cuminum cyminum, Picrorhiza kurroa, Ipomea turpethum, Tinospora cordifolia, Michelia champaka are some medicinal plants possess anti-obesity properties that had been indicated in Siddha classical text. The objective of this review is to validate the anti-obesity potentials of Siddha medicinal plants scientifically through various research reports. Due to the presence of Phyto compounds like phenols, flavonoids, terpenoids, alkaloids, anti-oxidants these medicinal plants revealed anti-obesity activities and its anti-obesity mechanism had been proven scientifically through various animal experimental studies collected from many research articles. Modern anti-obesity drugs produce numerous side effects. Regular consumption of Siddha anti-obesity medicinal plants, in the prescribed dose and duration, can induce gradual and sustainable weight loss effectively. Furthermore, in future, there is a need for the development of standardized, safe and effective anti-obesity drugs from medicinal plants and highly economical too. Hence eventually exploration of anti-obesity Siddha medicinal plants will lead to safe and effective treatment for obesity.

Survival Analysis Based on the Siddha Body Constitution of Asymptomatic SARS-CoV-2 Patients Under Integrative Management of Hydroxychloroquine (HCQ) and Kaba Sura Kudineer (KSK): A Retrospective Cross-sectional Case Series from Tirupati

Background: The present study analysed the impact of the integrated medical care of Hydroxychloroquine (HCQ) and Siddha herbal preparation KSK on asymptomatic COVID-19 patients based on their body constitution. Objective: The present study aimed to analyse the duration of the hospital stay of asymptomatic COVID-19 patients treated with the integrated medical care of hydroxychloroquine (HCQ) and herbal decoction of Kaba Sura Kudineer (KSK). Design: The study included a retrospective case series of 19 asymptomatic confirmed SARS-Cov-2 patients from District COVID Care Centre, Tirupati, India, between 23rd May to 7th June 2020. Methods: Clinical data were collected using a standardised case report form containing demographic information, length of hospital stays, and Siddha Yakkai Ilakkanam (body constitution) from the records. The association between the length of hospital stay, age, gender, and Siddha YI for the confirmed patients after admission was analysed by the Kaplan Meier survival analysis method. Results: Patients belonging to the Aiyam group stayed for at least nine days in the hospital, and 80% took ten or more days to cure the disease. About 71.4% took more than four days and three days of hospital stay in the Azhal and Vali groups, respectively. It was observed that 75% of females and 73.3% of males took nine days or more of hospital stay, respectively. The range of hospital stay was between 2-15 days for patients aged between 19 – 40 years. Conclusion: The present study explored the significance of integrating Siddha medicine with Western medicine in the management of SARS Cov-2 infection. An overall median of 9 days in the length of stay and 8.5 days in the overall mean survival time was documented. The patients of the present study on integrative treatment recovered about nine days earlier in comparison to the patients studied in Vietnam and China.

Effect of Siddha medicine Poorna chandirodayam and Gorojanai mathirai among Covid 19 patients suffering from hypoxia - A case series.

Gold, sulfur and mercurial formulations in Indian alchemy are consumed in conjunction with suitable adjuvant for their synergistic action, reduced toxicity and boosting their bioavailability resulting in improved effectiveness. Poorna chandrodaya chendooram is a well-known mercurial mixture containing gold and sulfur that has traditionally been used to treat a variety of diseases. Fel bovinum purifactum (Gorochanai) is an expectorant. It also acts as a bronchodilator. The second wave mutant virus has better transmission potential and a shorter incubation period than the first wave. Some diabetic patients treated for SARS-CoV-2 with high dose corticosteroids had a decrease in angioinvasive maxillofacial fungal infections (Mucormycosis). Without using synthetic steroids and with optimum oxygen support, this case report emphasizes the therapeutic success of administering Poorna chandirodayam and Gorojanai mathirai together with herbal and herbomineral Siddha formulations in the early inflammatory phase of COVID-19 infection. Five patients with the laboratory-confirmed diagnosis of coronavirus (SARS-CoV-2) infection admitted in the approved Siddha Covid hospital have been involved in the study. Metal-based medications P. chandirodayam and G. mathirai have been demonstrated through these case series to be safe and useful in COVID19.

An Alternate Approach in the Management of COVID-19 in Unvaccinated / Vaccine Allergic Population-A Case Study

The COVID-19 vaccines offer protection against the severe acute respiratory syndrome Corona virus 2 (SARS-CoV-2) by developing an immune response to the same. Further, there are mass vaccination programs being conducted across the globe. India administered COVID - 19 vaccines for more than 90 crores of people as on October 2021. However, there are still a bunch of people yet to receive vaccination. Adding to this, very few are found to be allergic to COVID - 19 vaccines. Hence there is a need for an alternative approach till the whole population of the world gets vaccinated. One such approach is prescribing Nilavembu kudineer and Kabha sura kudineer, a polyherbal Siddha medicine formulation of Traditional Indian system of Medicine. This case study highlights the positive effects and importance of the above mentioned polyherbal formulations in the management of mild to moderate COVID-19 patients. Hence, the same can be advised to the individuals who are yet to receive COVID-19 vaccine and persons who are allergic to COVID-19 vaccines.

Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India.

INTRODUCTION: Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India's Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases. METHODS: A prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis. RESULTS: Viral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups. CONCLUSION: KSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI2020/05/025215 . Registered on 16 May 2020.

Efficacy of two siddha polyherbal decoctions, Nilavembu Kudineer and Kaba Sura Kudineer, along with standard allopathy treatment in the management of mild to moderate symptomatic COVID-19 patients-a double-blind, placebo-controlled, clinical trial.

BACKGROUND AND AIM: Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medicines, especially polyherbal formulations like Nilavembu Kudineer (NVK) and Kaba Sura Kudineer (KSK) of the Siddha system of medicine, have been used as public health interventions for controlling viral epidemics like dengue and Chikungunya. These traditional therapies have been found safe, effective, and widely accepted. The current study evaluates the comparative efficacy of NVK and KSK as opposed to the placebo, in the management of mild to moderate COVID-19 disease. METHODS: The study was a double-blind, placebo-controlled comparative clinical trial, with the primary objective of determining the efficacy of KSK and NVK. Patients (n=125) diagnosed with mild to moderate COVID-19 symptoms were enrolled in the study over a period of 4 months (Aug 2020-Dec 2020). Participants were randomized into 3 arms; placebo-decaffeinated tea in Arm I, NVK in Arm II, and KSK in Arm III. Each arm received 60 ml of the respective treatment twice a day, post morning and evening meals, along with standard allopathy treatment for a maximum of 10 days. The main outcome measures of the study were the reduction in SARS-CoV-2 viral load, hospital stay, and time taken by the patients to become asymptomatic from symptomatic. Efficacy assessments included clinical symptoms (fever, cough, and breathlessness) each day and real-time reverse transcription-polymerase chain reaction (RT-PCR), liver function test (LFT), renal function test (RFT), and electrolytes and electrocardiogram (ECG) at baseline (day 0) and days 3, 6, and 10. Post-treatment, participants were followed up for 30 days via phone for adverse effects if any. Effects of drugs on inflammatory markers (IL6) at the end of treatment were also recorded. Adverse events (AE) were monitored throughout the study. RESULTS: The results revealed that when compared to patients in the placebo arm, those in NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and the time taken to become symptomatic from asymptomatic. Out of 125 COVID-19 patients recruited, 120 completed the study; two from the placebo group developed severe symptoms and were shifted to the intensive care unit (ICU) and three patients from Arms II and III withdrew from the study. The mean age of females (n=60) and males (n=60) enrolled was between 40.2 and 44.3 years, respectively. Results were more promising for all the patients in NVK and KSK arms as all enrolled participants (100%) under this group got discharged by day 6 as compared to only 42.5% (n=17) from the placebo group on that day. The hospital stay time for patients in Arm I was significantly longer (mean [SD]=8.4 [2.0] days) as compared to the Arms II and III (mean [SD]=4.7 [1.5] and 4.2 [1.5] days, respectively (Kruskal-Wallis test, P=0.0001). Patients in the three groups took a significantly different number of days to become asymptomatic. While Arm II and III patients took mean of 2.5 and 1.7 days, respectively, Arm I, patients took a mean of 4.2 days (Kruskal-Wallis test, P=0.0001). In all, two adverse events were recorded, one for vomiting and one for diarrhea lasting a day in Arm I and Arm II, respectively. The mean value of interleukin-6 (IL6) was significantly different in comparison to the placebo-decaffeinated tea arm (NVK=2.6 and KSK=2.2, placebo=4.0, P=0.02). The other blood biochemical parameters like C-reactive protein (CRP), lactate dehydrogenase (LDH), ferritin, and D-dimer that were analyzed at the baseline and at the time of discharge from the hospital, were not significantly different in the three arms. CONCLUSION: NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and time taken for patients to become asymptomatic from symptomatic, when compared to the placebo (decaffeinated tea). The primary outcome measures of the KSK arm were significantly better than those in the NVK arm.

A double blinded placebo controlled comparative clinical trial to evaluate the effectiveness of Siddha medicines, Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy treatment in the management of symptomatic COVID 19 patients - a structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: The primary objectives of the study are to determine the effectiveness of the Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy Treatment to compared with Placebo (Decaffeinated Tea) with standard Allopathy Treatment in the management of Symptomatic COVID 19 patients and also in reduction of Hospital Stay Time & Changes in Immunological (IL6) and Bio Chemical Markers (Ferritin, CRP, D-Dimer and LDH). The secondary objectives are to evaluate the safety of the trial medicines and their effects in the reduce the risks of the disease. In addition, to document the profile of Symptomatic COVID 19 patients as per Siddha Principles. TRIAL DESIGN: A Double Blinded, Three arm, Single Centre, Placebo Controlled, Exploratory and comparative Randomized Controlled Trial PARTICIPANTS: Patients who were admitted to the COVID Care Centre at Govt. Institute of Medical Sciences. Noida in India will be recruited. These will be patients with Mild and Moderate symptoms with laboratory confirmed COVID 19 (RT - PCR Tested Positive) aged 18-65, willing and consenting to participate. INTERVENTION AND COMPARATOR: Arm I: Decaffeinated Tea (Placebo - similar in taste and appearance to the other Two Decoctions), 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm II: Nilavembu Kudineer (The Siddha Medicines which is used as a standard Anti-Viral drug for the past Pandemics by Siddha Physicians) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm III: Kaba Sura Kudineer (The Siddha Medicine which is proposed to be used as a Treatment for COVID 19 based on Siddha Literature) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. The investigational drugs are registered products under the Govt.of India and bought from GMP Certified Manufacturing Units. MAIN OUTCOMES: Primary outcomes: 1. Reduction in Viral load of SARS-CoV-2 at the end of treatment (10 days). 2. Time taken to convert Patient from symptomatic to Asymptomatic based on Reduction in clinical symptoms (10 days). 3. Effect of drugs inflammatory markers (IL6,) at the end of treatment (10 days). 4. Reduction in hospital stay time (20 days follow up). (Based on RT PCR CT Value 3rd, 6th if needed 10th day). (Based on IL 6 Value needed 10th day or IL6 value on turning negative. (entry level/exit level). Secondary outcomes (10 days): 1. Reduction in use of Intensive Supportive Care. 2. Reduction in incidence of complications (Acute Respiratory Distress Syndrome, other systemic complications). 3. MuLBSTA score for viral pneumonia (multinodular infiltration, hypo-lymphocytosis, bacterial co infection, Total Leucocyte Count (TLC ≤ 0.8 x 109/L), smoking history, hyper-tension and age) score. 4. Laboratory markers (Haematological & Biochemical Markers). 5. Adverse events/effects Siddha-based measurements. 6. Siddha Udaliyal assessment by using Yakkai Ilakkanam (YI) Tool to diagnose body condition for covid-19 patients. RANDOMISATION: The assignment of the participants into 3 Groups will be allocated in 1:1:1 Ratio through randomization Blocks in Microsoft Excel by a Statistician who is not involved in the study. The allocation scheme will be made by another statistician by using a closed envelope after the assessment of eligibility and Informed consent procedures. The groups will be balanced for age and sex with 3:1 Ratio in each group for mild: severe COVID-19 symptoms. BLINDING: The Study is Double Blinded. Participants and Investigators were blinded. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): Sample size could not be calculated, Since there are no prior trials on KSK and NVK as a comparative trial. In addition, there are no prior trials on KSK and NVK in this region. A total Number of 120 Patients, 40 each in 3 groups will be recruited in 1:1:1 Ratio. TRIAL STATUS: Protocol Number : SCRUND GIMS Noida Study 1,Version: 2.0 Protocol Date : 20.08.2020 The recruitment period is completed for the trial. The Trial started its recruitment on 22.8.2020. We anticipate study including data analysis will finish in January 2021. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. TRIAL REGISTRATION: The trial protocol was registered with CTRI (Clinical Trial Registry of India) and number is CTRI/2020/08/027286 on 21.08.2020 FULL PROTOCOL: The full Protocol is attached as an additional file, Accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This letter serves as a summary of the key elements of the full protocol. The Study protocol has been reported in accordance with the SPIRIT guidelines.

The efficacy of Siddha Medicine, Kabasura Kudineer (KSK) compared to Vitamin C & Zinc (CZ) supplementation in the management of asymptomatic COVID-19 cases: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The primary objectives of this study are to determine efficacy of Siddha medicine, Kabasura kudineer in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 when compared to Vitamin C and Zinc (CZ) supplementation. In addition, the trial will examine the changes in the immunological markers of the Siddha medicine against control. The secondary objectives of the trial are to evaluate the safety of the Siddha medicine and to document clinical profile of asymptomatic COVID-19 as per principles of Siddha system of Medicine. TRIAL DESIGN: A single centre, open-label, parallel group (1:1 allocation ratio), exploratory randomized controlled trial. PARTICIPANTS: Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited. Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma. Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy will be excluded. INTERVENTION AND COMPARATOR: Adopting traditional methods, decoction of Kabasura kudineer will be prepared by boiling 5g of KSK powder in 240 ml water and reduced to one-fourth (60ml) and filtered. The KSK group will receive a dose of 60ml decoction, orally in the morning and evening after food for 14 days. The control group will receive Vitamin C (60000 IU) and Zinc tablets (100mg) orally in the morning and evening respectively for 14 days. MAIN OUTCOMES: The primary outcomes are the reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR] from the baseline to that of seventh day of the treatment, prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha]. Clinical assessment of COVID-19 as per standard Siddha system of medicine principles and the occurrence of adverse effects will be documented as secondary outcomes. RANDOMISATION: The assignment to the study or control group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and informed consent procedures. BLINDING (MASKING): This study is unblinded. The investigators will be blinded to data analysis, which will be carried out by a statistician who is not involved in the trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Sample size could not be calculated, as there is no prior trial on KSK. This trial will be a pilot trial. Hence, we intend to recruit 60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm. TRIAL STATUS: Protocol version 2.0 dated 16th May 2020. Recruitment is completed. The trial started recruitment on the 25th May 2020. We anticipate study including data analysis will finish on November 2020. We also stated that protocol was submitted before the end of data collection TRIAL REGISTRATION: The study protocol was registered with clinical trial registry of India (CTRI) with CTRI/2020/05/025215 on 16 May 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).