Evaluation of Clinical Efficacy and Safety of Nigella Sativa Seed Oil added to Standard Treatment in Uncomplicated Respiratory Infection - A Randomised, Open Labelled, and Parallel Arm Study

Abstract

Introduction: Nigella sativa, known for its various pharmacological activities, is under trial for COVID-19. Objectives: The objectives were to assess the efficacy of Nigella Sativa, a traditional herbal medicine, added to standard treatment in the management of uncomplicated respiratory infection in terms of reduction in severity and worsening of clinical symptoms and to assess its safety through the incidence of adverse events. Method: The study was an open-labelled, parallel-arm, randomised controlled study in 50 participants with uncomplicated respiratory infections. Patients with symptoms of respiratory infections including fever, sore throat, throat pain, rhinitis, headache, myalgia and cough with or without expectoration for 5 days or less, were enrolled in the study. They were randomly allocated to two groups: Group 1 received standard treatment for 7 days and Group 2 Nigella Sativa oil - 1000mg twice daily with standard treatment for 7 days. The patients were physically followed up on day 4 and day 7 after starting treatment. General and systemic examination, assessment of vitals including body temperature, assessment of adverse events and clinical response to treatment were carried out during each visit. Results: The two groups showed similar efficacy for improvement in clinical symptoms on day 7. But on day 4, more subjects became symptom-free in Group 2 (N. sativa + standard treatment) as compared to Group 1 (standard treatment alone). The incidence of adverse events was similar in both groups and all the adverse events were minor in nature. Conclusion: Hence it is concluded that the addition of N. sativa to standard treatment could potentially benefit the patients with uncomplicated respiratory infection with early clinical cure.