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

• Published in: Current controlled trials in cardiovascular medicine 2021-08, Vol.22 (1), p.570-11, Article 570
• Main Authors: Srivastava, Anurag, Rengaraju, Manickavasagam, Srivastava, Saurabh, Narayanan, Vimal, Gupta, Vivek, Upadhayay, Rashmi, Kumar, Jitender, Parameswaran, Sathiyarajeswaran, KanakavalliKadarkarai, AarthiVelmurugan
• Format: Article
• Language: English
• Subjects: Allopathy; Biological products; Chromatography; Clinical trials; Coronaviruses; COVID-19; Dengue fever; Diarrhea; Disease; Double-Blind Method; Double-blind studies; Double-blinded RCT; Drug-Related Side Effects and Adverse Reactions; Epidemics; Female; Folk medicine; Herbal medicine; Hospitals; Humans; Kaba Sura Kudineer; Male; Medical research; Medicine; Medicine, Ayurvedic; Methods; Middle Aged; Mild to moderate COVID-19; Molecular weight; Nilavembu Kudineer; Oxygen saturation; Patients; Phytochemicals; Pneumonia; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Siddha medicine; Steroids; Testing
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05478-0

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. 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. 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