NCT04797936.
Study name | BNO 1030 extract (Imupret) in the treatment of mild forms of COVID‐19 |
Methods | Two‐arm, open‐label, parallel‐group RCT with 14 days duration of treatment and follow‐up |
Participants | Adult participants with mild COVID‐19 and nasal symptoms (either congestion, rhinorrhoea or anosmia/hyposmia) Inclusion criteria:
Exclusion criteria:
Estimated sample size: 133 participants |
Interventions |
Intervention: Imupret (BNO 1030) 25 drops, given 6 times per day for 14 days. Imupret described elsewhere as a herbal intervention comprising marshmallow root (Radix Althaeae), chamomile flowers (Flores Chamomillae), horsetail herb (Herba Equiseti), walnut leaves (Folia Jungladis), yarrow herb (Herba Millefolii), oak bark (Cortex Quercus), dandelion herb (Herba Taraxaci) Comparator: No intervention. Symptomatic therapy as needed, including anti‐pyretics and saline solutions in the nose 4 times a day for 14 days. We assume that symptomatic therapy will also be provided for the intervention group, but this is not explicit in the protocol. |
Outcomes |
Outcomes of interest in the review: Primary outcomes: Presence of normal olfactory function
Serious adverse effects
Change in sense of smell
Secondary outcomes: Prevalence of parosmia
Change in sense of taste
Disease‐related quality of life
Other adverse effects (including nosebleeds/bloody discharge)
Other outcomes reported by the study:
|
Starting date | 1 May 2020 |
Contact information | Vasyl Popovych. No contact details provided. |
Notes | Estimated completion date 8 January 2021 Trial registered in Ukraine We assume that, as symptom scores are assessed during the study, these participants will be in the early stages of COVID‐19 infection and this study will be relevant for this review (< 4 weeks since olfactory dysfunction). However, this is not explicit in the protocol. |