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

• Published in: Current controlled trials in cardiovascular medicine 2021-02, Vol.22 (1), p.130-3, Article 130
• Main Authors: Srivastava, Anurag, Rengaraju, Manickavasagam, Srivastava, Saurabh, Narayan, Vimal, Gupta, Vivek, Upadhayay, Rashmi
• Format: Article
• Language: English
• Subjects: C-Reactive Protein - metabolism; CAM; Clinical trials; Coronaviruses; COVID 19; COVID-19 - blood; COVID-19 - drug therapy; COVID-19 - physiopathology; Double-Blind Method; Ferritins - blood; Fibrin Fibrinogen Degradation Products - metabolism; Herbal; Hospitalization; Humans; Interleukin-6 - blood; L-Lactate Dehydrogenase - blood; Laboratories; Length of Stay - statistics & numerical data; Letter; Medicine, Ayurvedic; Plant Preparations - therapeutic use; Protocol; Randomised Controlled Trial; Randomized Controlled Trials as Topic; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Siddha Medicine
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05041-x

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. 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. 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. 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 3 , 6 if needed 10 day). (Based on IL 6 Value needed 10 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