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.