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 regimensTiryaq-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.
ABSTRACT
The novel coronavirus disease (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The immune response to SARS-CoV-2 can play an important role in disease pathogenesis and clinical manifestations. Considering the antiviral, immuno-modulatory, anxiolytic, antiinflammatory and antioxidant properties, this open labelled, controlled, interventional, prophylactic study was conducted on individuals at risk in containment zones of different cities of India, viz., Lucknow, Aligarh, New Delhi, Srinagar, Mumbai and Bengaluru. The study focuses on number of patients turning COVID-19 positive, change in ISQ and WHOQOL-BREF scales in both the groups. Apparently, healthy individuals at risk in containment zones were divided into intervention and control groups. The intervention group was further divided into two subgroups. The first subgroup received Unani regimen- I including Unani Joshanda with Khamira Marwareed (KM), the second subgroup received Unani regimen- II including Unani Joshanda with Tiryaq Arba (TA). The control group did not receive any intervention. The duration of intervention was 20 days;follow ups were planned on day 10, day 20 and day 35. A total number of 33021 participants were enrolled in the study, of which 30,931 participants completed the study. It was observed that individuals receiving Unani regimen-I demonstrated lower risk of developing COVID-19 by 74% and those receiving Unani regimen-II by 62% in comparison to the control group. Interventional groups showed highly significant (p<0.001) effect on the quality of life.
ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread globally. COVID-19 presents varied clinical features. The present study focuses on number of patients turning COVID-19 positive, change in Immune Status Questionnaire (ISQ) and WHO quality of life-Bref (WHO Qol – BREF) scales after taking intervention. This open labelled, double arm, controlled, interventional, clinical trial was conducted on high-risk individuals i.e., those residing with a COVID-19 positive member in the identified quarantine area. This twin armed study was conducted on asymptomatic individuals exposed to COVID-19. The test group were prescribed Unani poly-herbal decoction together with Unani formulations Khamira Marwareed and Tiryaq e Arba whereas the control group was not on any intervention. The duration of intervention was 20 days;follow ups were planned on day 10 and day 20. Of the 81 participants enrolled, none of the patients turned COVID-19 positive. However, 13.58% (n=11) developed COVID like symptoms and 70 patients completed the study. The mean age of the participants was 41.42±16.9 years;however, majority of the participants were 18-28 years male with Damvi (Sanguine) temperament. The quality of life of the intervention group improved significantly however, the immune status in both the groups increased with P <0.001. The Unani prophylactic regimen provides a 62% (relative risk reduction) protection against COVID-19. This pilot study paves for a study on a larger population. No adverse effects were observed during the study. Absence of biochemical investigations were limitations to the study. © 2022, National Institute of Science Communication and Information Resources. All rights reserved.