CTRI/2020/08/027033.

Study name	SARS‐COV‐2 and COVID‐19 ‐ a randomized controlled trail
Starting date	07 August 2020
Contact information	Dr N Anbu    Department of General Medicine, Government Siddha Medical College, Arumbakkam Chennai 106 600106 Chennai, TAMIL NADU India 9443279412 | nanbu.sumi@gmail.com
Methods	Interventional, RCT, multiple arm trial, 1:1; open label
Participants	100 participants, ≥ 18 years, female and male Inclusion criteria: RT‐PCR‐positive patients Asymptomatic patients Fever Dry cough Sore throat Difficulty in breathing Exclusion criteria: Bronchogeniccarcinoma Pulmonary TB Pregnancy and lactating mothers Status asthmatic
Interventions	Experimental:  Kabasura kudineer: tab azithromycin 500 mg twice daily oral administration Tab hydroxychloroquine 200 mg oral administration Tab paracetamol 650 mg twice daily oral administration Inj methylprednisolone IV Inj enoxaparin IV Tab vitamin C oral administration Tab zinc oral administration Tab multivitamin oral administration Kabasura kudineer 60 mL oral administration Comparator: Nilavembu kudineer 60 mL twice daily oral administration for 14 days Kabasura kudineer 60 mL twice daily oral administration for 14 days Thippili rasayanam 5 g twice daily oral administration for 14 days Aadathodai manapagu 5 mL twice daily hot water oral administration for 14 days Swasakudori maathirai 2 twice‐daily hot‐water oral administration for 14 days Thoothuvalai legiyam 5 g twice daily with milk oral administration for 14 days Amukara chooranam 2 g twice daily oral administration for 14 days Seenthil chooranam 2 g twice daily oral administration for 14 days Pavala parpam 100 mg twice daily oral administration for 14 days Silasathu parpam 100 mg oral administration twice daily for 14 days Sivanar amirtham 60 g twice daily oral administration for 14 days Muthu parpam 100 mg twice daily oral administration for 14 days Gargle‐ with turmeric, thripala, alum, glycyrrhiza glabra, salt
Outcomes	Primary Outcomes mainly assessed by reduction in clinical symptoms and RT‐PCR test negative. Time point: 3 months Secondary Outcomes mainly assessed by reduction in clinical symptoms and RT‐PCR test negative The outcome is assessed by patients' recovery progress with faster reductions in clinical symptoms and RT‐PCR test negative, also to avoid the mortality rate by administering allopathy and Siddha medicines for the easy recovery and safety measures in the treatment for SARS‐CoV‐2 and COVID‐19. Time point: 3 months
Notes	CTRI/2020/08/027033 | No data provided | Source(s) of monetary support: Govt Kilpauk Medical College Hospital Chennai 600010