The efficacy of Siddha Medicine, Kabasura Kudineer (KSK) compared to Vitamin C & amp; Zinc (CZ) supplementation in the management of asymptomatic COVID-19 cases: A structured summary of a study protocol for a randomised controlled trial

This study is unblinded. The investigators will be blinded to data analysis, which will be carried out by a statistician who is not involved in the trial.Numbers to be randomised (sample size)Sample size could not be calculated, as there is no prior trial on KSK. This trial will be a pilot trial. Hence, we intend to recruit 60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm.Trial statusProtocol version 2.0 dated 16th May 2020. Recruitment is completed. The trial started recruitment on the 25th May 2020. We anticipate study including data analysis will finish on November 2020. We also stated that protocol was submitted before the end of data collectionTrial registrationThe study protocol was registered with clinical trial registry of India (CTRI) withCTRI/2020/05/025215 on 16 May 2020.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file1). 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 Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file2).
Source: Trials - Category: Research Source Type: clinical trials