Eligible patients will be invited to participate in the study. They will be provided with the details of clinical trial and their willingness to participate in study. Participants will be informed that they are ready to withdraw anytime from the trial. Computer generated stratified randomization code ( strata: asymptomatic , mild , moderate) will be prepared and allocation in two study arms will be done using sequentially numbered opaque envelopes by dept clerk not involved in study. Each participants will be examined with detailed history, general and systemic examination. Baseline laboratory investigation i.e cbc, rbs, thyroid profile, LFT and RFT will be carried. However treatment will be started before the results of test are available. If any abnormality detected in baseline investigations then participant will be removed from the study and reason will be noted. If in intervention arm then Kabasura  kudineer will be stopped and will be offered to take the allopathy treatment as per standard protocol. If in control arm then will continue to take the allopathy drug. Replacement of this participants will be done till required 50 is selected in each group. Case proforma will be filled accordingly. 

Study arms 

For asymptomatic and mild cases 

Arm 1 - trial group- Kabasura  kudineer tablet formulation

Arm 2 - control group – only allopathic medicines as per standard protocol by goi i.e Tab vitamin c oral once a day for 15 days and Paracetamol 500 mg sos not more than 4 tabs a day, cetrizine 10 mg od for 5 days, cough syrup 5-10 ml bd for 5 days etc 

For Moderate cases 

Arm 1 - trial group- Kabasura  kudineer tablet formulation with standard allopathy as per GOI and institutional protocol 

Arm 2 - control group standard allopathy as per GOI and institutional protocol 

Details of intervention 

Kabasura  kudineer: Participants in this arm will receive ayush formulation Kabasura  kudineer tablet which is classical siddha formulation that licenced with no. Aus 782, licensing authority : Dept of Ayush, Karnataka. Two tab will be given thrice a day after food for period of 15 days . Participants will be advised to be take medicine only after food. 

Standard treatment 

Asymptomatic : Home isolation, tab Vitamin C, Maintain hydration, Symptom monitoring 

Mild case: Home isolation , Vitamin C + symptomatic treatment , Maintain hydration,Symptom monitoring  

Moderate case : Hospitalize and treat as per protocol 

Follow Up, monitoring of symptoms and complaince to treatment   : 

Participants will be followed on day 5,10, 15 and 21-28 either physically in OPD or by telephone irrespective of presence or absence of symptom. Atleast 2 visits is must for each participants. PRIEST score will be calculated during each visit. Daily monitoring of symptoms and Compliance with treatment will be assessed telephonically and counsel to complete the treatment . Those who are non complaint for more than 3 occasions will be noted as non complaint and reason for non complaince will be noted. They will be informed on importance of isolation, Covid care and monitoring the symptom of their family memebers. Participants will be told to visit hospital in case of any aggravation of symptom or developing new symptoms. They will be treated according to std protocol.   

Participants withdrawal criteria

1.Participants are free to withdraw from trial at any point of time (reason for withdrawal will be noted in CRF) 

2. If any adverse reaction or side effect during the study. Decision will be taken after through investigation by researchers. Reason will be noted and informed to institutional  ethics committee and sponsor within 24 hours. Participant will be treated as per standard protocol of hospital. 

Statistical Methods

Baseline characteristic of both the group will be reported in terms of proportion/ Mean (SD) and difference at baseline will be assessed by chi square or t test respectively. Intention to treat analysis will be applied. Categorical pre and post variables of each group and between the group will be analysed using chi square. Continuous variables will be analyzed depending on distribution of data by parametric or non-parametric statistics. Post hoc power analysis will be carried out to assess the power of study. 

Stopping the trail 

If one adverse event / death is found to be associated with intervention drug after doing casualty assessment and submitting the report to IEC , then drug trail will be stopped. 

Ethics Clearance:

Ethical permission from IEC, AIIMS Rishikesh will be taken before the start of study. Study will be registered with CTRI.  Helsinki Declaration,  ICH-GCP Guidelines and ethical guidelines of ICMR, New Delhi will strictly adhered. 

Privacy and Confidentiality

Privacy and confidentiality of data of participants will be strictly maintained. Personal identity of participants will never be revealed and will be coded. Data will be kept in secured locked cabinet and soft copy with password locked. This will not be shared with those outside research team. Identity of participants will not be revealed  in any  meeting or publication or conference . Data will be stored for period of 5 years.