Abstract
Background & 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 till date. Indian traditional medicines, especially poly herbal 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 randomised into 3 arms; placebo-decaffeinated tea in Arm 1; 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), Day 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 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 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 placebo groupon 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 Arm 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 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 diarrhoea lasting a day in Arm I & Arm II respectively. 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 analysed at the baseline and at the time of discharge from 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 KSK arm were significantly better than that in the NVK arm.
Herbs of rich-Iodine for Graves’ Hyperthyroidism Trial (the HIGHT trial): a study protocol for a randomized, double-blind, placebo-controlled, multicentre clinical trial
