Efficacy of the Unani Regimen as an Add-On to Standard Treatment in Hospitalised RT-PCR-Confirmed Mild to Moderate COVID-19 Patients: An Open-Label Randomized Controlled Trial

Abstract

Background The coronavirus disease 2019 (COVID-19) pandemic resulted in mortality and morbidity worldwide. Many treatment modalities have been experimented with limited success. Therefore, the traditional system of medicine needs to be explored. Objective To evaluate the benefits of Unani regimens Tiryaq-e-Arba and Unani Joshanda, as adjuvant therapy, were compared to standard treatment alone among reverse transcription polymerase chain reaction (RT-PCR)-confirmed mild to moderate COVID-19 cases. Materials and methods An open-label, double-arm, randomized, controlled interventional clinical study was conducted among 90 RT-PCR-confirmed mild to moderate COVID-19 inpatients admitted to a tertiary care hospital in New Delhi, India. Participants who fulfilled the criteria for inclusion were randomly assigned to two arms, with 43 subjects allocated to the Unani add-on arm and 47 subjects to the control arm receiving standard treatment alone. Results Clinical recovery was achieved in all patients of the Unani arm, while in the control arm, three (6.4%) patients deteriorated and had to be shifted to ICU following admission. In the intervention arm, a shorter duration of hospitalization was observed (mean 5.95 days {SD = 1.99}) than in the control arm (mean 7.62 days {SD, 4.06}); which was a statistically significant difference (p-value 0.017). The majority of the patients recovered within 10 days in the Unani add-on arm. The number of days taken for the reduction of symptoms was significantly less in the intervention arm (mean 5.14 days {SD, 2.39}) as compared with standard treatment (mean 6.53 days {SD, 3.06}) (p < 0.02). Renal and liver safety parameters were within the normal limits in both arms and no serious adverse event was reported. Conclusion Adding Unani formulations to standard treatment significantly reduced the duration of hospital stay and showed early recovery in COVID-19 patients compared with the control arm. It may be concluded that the synergistic effect of the Unani add-on with standard treatment gave more promising results in mild to moderate COVID-19 patients.