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Background: The use of complementary and alternative medicine (CAM) therapies has surged since the spread of COVID-19 pandemic. However, the efficacy and safety of these CAM therapies remains majorly unexplored. Objective: To understand the efficacy and safety of Nochi Kudineer Chooranam (5 gm), Mahasudarsan Chooranam (3 gm) , Adathodai Manapagu (10 ml), Omatheeneer (10 ml), Maldevi chenduram (100 mg) with honey in management of COVID 19 patients. Methods: We conducted a randomised, controlled, open label trial in patients hospitalized with SARS-CoV-2 infection who had an oxygen saturation of 90% or more while breathing ambient air. Patients were randomized into two groups in a 1:1 ratio to either intervention group, receiving seven days of siddha medicine (Intervention group; n = 50) or standard care (control group; n = 50). The primary end point was clinical markers and patient recovery status on day 8. Results: A total of 100 patients with confirmed COVID-19 with average age of 37 yrs (interquartile range, 28-49) participated in the study. There was no statistically difference between groups at baseline (P > 0.05). After intervention, patients in the intervention group had statistically (P < 0.05) significant reduction in the symptoms when compared to standard care. By end of the intervention period, 6 patients (12%) were hospitalized in the control group and none of them were reported for intervention group. Conclusion: Among patients with mild to moderate COVID-19, 7 days of siddha medicine showed a significant reduction in the clinical symptoms and requirement of hospitalisation, with no adverse events. Therefore, the particular siddha medicine preparation could be used safely and effectively for the management of COVID-19 patients.
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Background The use of complementary and alternative medicine (CAM) therapies has surged since the spread of COVID-19 pandemic. However, the efficacy and safety of these CAM therapies remains majorly unexplored. Objective of the current study is to understand the efficacy and safety of one such traditional CAM therapy of South India, known as ‘Siddha’ system of medicine, in the management for the COVID-19 patients. Methods We conducted a randomised, controlled, open label trial in patients hospitalized with SARS-CoV-2 infection who had an oxygen saturation of 90% or more while breathing ambient air. Patients were randomized into two groups in a 1:1 ratio to either intervention group, receiving seven days of siddha medicine (Intervention group;n=50) or standard care (control group;n=50). The primary end point was clinical markers and patient recovery status on day 8. Results A total of 100 patients with confirmed COVID-19 with average age of 37 yrs (interquartile range, 28-49) participated in the study. There was no statsistically difference between groups at baseline (P>0.05). After intervention, patients in the intervention group had statistically (P<0.05) significant reduction in the symptoms when compared to standard care. By end of the intervention period, 6 patients (12%) were hospitalized in the control group and none of them were reported for intervention group. Conclusion Among patients with mild to moderate COVID-19, 7 days of siddha medicine showed a significant reduction in the clinical sysmptoms and requirement of hospitalisation, with no adverse events. Therefore, the particular siddha medicine preparation could be used safely and effectively for the management of COVID-19 patients. Clinical Trial Registration CTRI/2020/08/026999.
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Introduction: Non-tested asymptomatic COVID-19 cases poses threat of transmitting the disease silently. The Siddha polyherbal formulation, hnology Kabasurakudineer, (KSK) was found to be effective in preventing viral replication of SARS-CoV-2 by in-silico studies. A pilot study was conducted to test the antiviral activity of KSK in asymptomatic individuals tested positive for COVID-19. Methods: A single centre, open labelled, randomized controlled study was carried out during June-August 2020, in Tertiary Medical College Hospital, after approval from the institutional ethics committee and registered in CTRI. RTPCR confirmed COVID-19 asymptomatic cases, aged 18-65 years, consented to participate were . included and those with co-morbidities like diabetes, hypertension, severe respiratory disease, malignancies, pregnant and lactating mothers were excluded. Hospitals of Semnan Uniiessi y 60 participants were randomly assigned to study and control group. Study group received KSK (60 ml) along with vitamin C in the morning and zinc in the night, while the control group (CZ) received vitamin C and zinc for 10 days. The primary outcome was the reduction in the SARS-CoV-2 load (ct value), prevention of progression to symptomatic state. Results: In the study group, there was faster reduction in the viral load in terms of ct value as all the 30 participants turned negative for SARS-Co-V2, while 4 remain positive in the control group on the 10th day. The inflammatory markers and serum cytokine findings were inconclusive. No one progressed to the symptomatic state and no adverse event was reported in either groups. Conclusion: This study demonstrated the potential of Kabasurakudineer in reducing the viral load. Further clinical studies are warranted with larger sample size.
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Siddha's system of medicine is the effective one to reduce the symptoms of many viral illnesses. Siddha's system of medicine in asymptomatic, mild to moderate Covid-19 Positive patients, will make them recognize its effectiveness, reduce the symptoms, and move into the traditional approach towards the deadliest pandemic disease Covid-19. The objective of this study is to evaluate the acceptance and benefit of integrative Siddha management among the mild, moderate and asymptomatic COVID patients through a feedback questionnaire in TPEC COVID Care Center, Vellore, Tamil Nadu (TPECThanthai Periyar Engineering College). 74 asymptomatic, mild to moderate Covid-19 Positive patients were observed 7 days from 14.07.2020 to 30.07.2020 in TPEC COVID Care Center, Vellore, Tamil Nadu. During this period, Siddha medicines were administrated along with Western medicine. At the end of the period, validated feedback questionnaires were used to collect information from 74 participants for evaluating the acceptance and benefit of integrative Siddha management.In the 74 patients of TPEC COVID Care Center, Vellore, 100% were taken the given Siddha drug properly. 82.4% had the most common symptoms and 52.7% had less common symptoms. 16.2% of cases developed gastric acidity and 1.3% developed mild dyspnea as an ADR. 91.8% were recommended the Siddha system to others. 93.2% reported excellent disease progress. 90.7% of Siddha doctors quoted for 'Excellent' service on covid patients. This feedback report explores the three important significance. (a) Siddha medicine having significant effectiveness (b) Siddha medicines have safety in covid-19 patients (c) overall services of Siddha doctors are appreciatable by the patients and Siddha system is recommended to others. This analysis report helps to provide the possibility of the Siddha system for further or future clinical trials.
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Despite the threat of coronavirus infection, the Siddha system of medicine, India's traditional medicine, plays an important role in southern India, particularly in Tamilnadu. It contributed considerably not only in the first wave of Covid-19, but also in the second wave. The Government of Tamilnadu developed Siddha COVID-19 treatment centers for asymptomatic, mild, and moderate COVID-19 positive patients in 2020. The TPEC COVID Care Centre initiated at Vellore also one of the Centers that can be managed by Siddha medicines and Siddhar's Yogam. As of July 14, 2021, about 4525 COVID positive patients had been treated with Siddha integrated treatment at Vellore alone in the first and second waves. Kaba Sura Kudineer, Thalisathy Vadagam, Amukkara Chooranam Mathirai, Bramanandha Bairavam Mathirai, and Adathodai Manapagu are indeed the five Siddha classical preparations used to manage the symptoms of COVID-19 positive patients at TPEC COVID Care Centre in Vellore. This Siddha medical practice is effective in conditions of symptoms and helps in the reduction of clinical outcomes. A pilot study at the same site confirmed the Siddha classical preparation's safety and effectiveness. A feedback analysis study performed at the same center also revealed that the above-mentioned Siddha classical preparations are beneficial in symptomatic treatment without causing any side effects. The medicines utilized in this study are typically proposed in other COVID care centers also in Tamilnadu. This review attempted to analyze the preclinical and clinical efficacy of Siddha Classical medicines used at that Centre for the management of COVID-19.
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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.
Subject(s)
COVID-19 , SARS-CoV-2 , Ascorbic Acid , Dietary Supplements , Humans , India , Medicine, Ayurvedic , Prospective Studies , Treatment Outcome , Viral Load , ZincABSTRACT
Background: Covid-19 is a global pandemic since 2019. SARS-CoV2 is a new virus that originated from China and is currently spread across 160 countries. Siddha medicine is one of the traditional Indian medicines, part of Ayush that tend to treat several acute and chronic diseases. Aim: The objective of this study is to observe the safety and efficacy of Siddha regimen with lab parameters like LFT, RFT, RT-PCR, LDH, FERRITIN levels, and prevention of disease complications in covid-19 positive patients on the 7th day of treatment. Experimental Procedure: A nonrandomized open-label observational retrospective study was designed. Twenty patients of either sex, of age between 18 and 60 years, were selected with proper consent. The covid patients who were confirmed by positive RT-PCR test results with or without clinical features of covid-19 were selected. They were treated with Siddha Regimen for seven days. Results: Sixteen out of 20 cases turned RT-PCR negative on their 7th day of treatment. And the Ct value of RT-PCR was statistically significant. LDH and Ferritin levels were reduced after the treatment even though the before treatment values are in the normal range. The LDH level was statistically significant on the 7th day of treatment. No Remarkable changes in the safety laboratory parameters like SGOT, SGPT, Blood urea, Serum Creatinine. Conclusion: Significant changes in efficacy laboratory parameters and no changes in safety laboratory parameters have been reported in the Siddha fixed regimen for covid-positive patients. All the 20 study participants were recovered without emergency and hospitalization.
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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).