Study design, participants, and ethics
ARI, OPD
ACUTE RESPIRATORY INFECTION, RECRUITMENT, DELHI, GROUP B
A three-armed, open-labeled, randomized clinical trial was undertaken from November 2020 to September 2021. A total of 150 patients were recruited at the screening OPD and COVID health centre of All India Institute of Ayurveda (AIIA), New Delhi and ARI (acute respiratory infection) OPD and Corona Ward, ESIC Medical College and Hospital, Faridabad, Haryana. The inclusion criteria were (1) diagnosis of COVID-19 positive based on RAT and RT-PCR results; (2) age 19–65 years; (3) presenting with no or mild symptoms (SpOThe 150 random numbers were generated using 3-digit random numbers tables and allocation to 3 groups was done: Group A (even number), Group B (odd number) and Group C (number multiple of 3). As per this, 52 patients in Group A, 51 patients in Group B and 47 patients in Group C were enrolled in the study. This study was carried out in accordance with the recommendations of the Indian Council of Medical Research, India guidelines for biomedical research, with written informed consent from all subjects. The study protocol was approved by the Institutional Human Ethics Committee of CSIR-Institute of Genomics and Integrative Biology (IGIB), New Delhi, All India Institute of Ayurveda (AIIA), New Delhi and ESIC Medical College and Hospital, Faridabad, Haryana, India. The study was registered in the Clinical Trials Database with Registration no. CTRI/2020/09/028043. The trial drug capsules of extracts of At the time of enrollment, patients were provided information on how to record their vitals and report their clinical symptoms daily such as temperature, pulse, blood pressure (BP), respiratory rate (RR) and oxygen saturation levels. They were provided pulse oximeters to facilitate accurate reporting of SpOAfter enrollment in the intervention, 14 patients (two, eight, and four from AV, TC, and AV + TC, respectively) were lost to follow-up. Among these, eleven individuals did not provide any information about medication taken/ not and no follow-up/tests could be done after enrollment. Two patients were enrolled based on RAT, however they turned negative on RT-PCR, hence did not initiate the treatment. One patient took intervention and provided clinical follow-up for the recovery of symptoms but did not come for final blood/RT-PCR tests, hence the data were not included in the final analysis. A total of 136 patients completed the study with RT-PCR negative, out of which 67 subjects gave their blood samples at the three time points (Fig. Recruitment and randomization of the patients. 150 COVID-19 positive patients were enrolled in the clinical trial. We randomized 150 patients who met the inclusion criteria into Group A (