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Efficacy of a Persian herbal medicine compound on coronavirus disease 2019 (COVID-19): a randomized clinical trial

Setayesh et al., Integrative Medicine Research, doi:10.1016/j.imr.2022.100869, IRCT20200330046899N1
Jun 2022  
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Mortality -8% Improvement Relative Risk Oxygen time 27% Hospitalization time 29% Nigella Sativa  Setayesh et al.  LATE TREATMENT  RCT Is late treatment with nigella sativa + combined treatments beneficial for COVID-19? RCT 79 patients in Iran (June - September 2020) Lower need for oxygen therapy (p=0.007) and shorter hospitalization (p<0.0001) c19early.org Setayesh et al., Integrative Medicine .., Jun 2022 Favorsnigella sativa Favorscontrol 0 0.5 1 1.5 2+
12th treatment shown to reduce risk in January 2021, now with p = 0.00016 from 14 studies.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Small RCT 41 patients treated with nigella sativa, glycyrrhiza glabra, punica granatum, and rheum palmatum, and 41 control patients, showing shorter hospitalization with treatment.
risk of death, 7.9% higher, RR 1.08, p = 1.00, treatment 1 of 38 (2.6%), control 1 of 41 (2.4%).
oxygen time, 26.8% lower, relative time 0.73, p = 0.007, treatment mean 3.0 (±1.6) n=38, control mean 4.1 (±1.9) n=41.
hospitalization time, 28.7% lower, relative time 0.71, p < 0.001, treatment mean 5.7 (±1.9) n=38, control mean 8.0 (±1.8) n=41.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Setayesh et al., 3 Jun 2022, Randomized Controlled Trial, Iran, peer-reviewed, mean age 59.1, 7 authors, study period June 2020 - September 2020, this trial uses multiple treatments in the treatment arm (combined with glycyrrhiza glabra, punica granatum, and rheum palmatum) - results of individual treatments may vary, trial IRCT20200330046899N1. Contact: hasheminasab@zaums.ac.ir, hashemifa67@gmail.com.
This PaperNigella SativaAll
Efficacy of a Persian herbal medicine compound on coronavirus disease 2019 (COVID-19): A randomized controlled trial
Mohammad Setayesh, Mehrdad Karimi, Arman Zargaran, Hamid Abousaidi, Armita Shahesmaeili, Fatemeh Amiri, Fatemeh Sadat Hasheminasab
Integrative Medicine Research, doi:10.1016/j.imr.2022.100869
Background: The global attention to the capacities of traditional medicine for alleviating the clinical manifestations of COVID-19 has been growing. The present trial aimed to evaluate the efficacy and safety of a Persian herbal medicine formula among patients with COVID-19. Methods: The present trial was conducted in Afzalipour hospital, Kerman, Iran, from June to September 2020. Hospitalized COVID-19 patients were randomly divided into intervention (Persian herbal medicine formula + routine treatment) or control (only routine treatment) groups. The intervention group received both capsule number 1 and 2 every 8 hours for 7 days. Capsule number 1 contained extract of the Glycyrrhiza glabra, Punica granatum , and Rheum palmatum , and the second capsule was filled by Nigella sativa powder. Participants were followed up to 7 days. The primary outcome was the number of hospitalization days, while cough, fever, and respiratory rate, days on oxygen (O 2 ) therapy, and mortality rate were considered as the secondary outcomes. Results: Eighty-two patients were enrolled to the study, while 79 cases completed the trial and their data were analyzed (mean age: 59.1 ± 17.1 years). Based on the results, the Persian medicine formula decreased the mean hospitalization days, so that the mean difference of length of hospitalization as primary outcome was 2.95 ± 0.43 days. A significant clinical improvement was observed regarding dyspnea, need for O 2 ) therapy, and respiratory rate in the intervention group. No adverse effects were reported. Conclusion: The present study supported the use of the Persian medicine formula as an adjuvant therapy for hospitalized COVID-19 patients. Study registration: Iranian Registry of Clinical Trials (www.irct.ir): IRCT2020 0330 046899N1. Study registration: Iranian Registry of Clinical Trials (www.irct.ir): IRCT2020 0330 046899N1.
Conflict of interest There was no conflict of interest in this study. CRediT authorship contribution statement
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Late treatment
is less effective
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