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. 2022 Sep 5;2022(9):CD013877. doi: 10.1002/14651858.CD013877.pub3

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:
  • Aged 18 to 70 years

  • Clinical signs of mild COVID‐19, with at least one of: nasal congestion, rhinorrhoea or anosmia/hyposmia

  • Contact with a confirmed or suspected case of COVID‐19

  • Able to be treated as an outpatient


Exclusion criteria:
  • Presence of immunodeficiency, oncological disease, chronic cardiovascular or lung disorders, diabetes mellitus

  • Intolerance to components of the medication


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
  • Self‐reported anosmia on a VAS, range 0 to 10, 0 = no symptoms; unclear whether this will be reported as a dichotomous outcome


Serious adverse effects 
  • Not reported


Change in sense of smell
  • Self‐reported anosmia on a VAS, range 0 to 10, 0 = no symptoms


Secondary outcomes:
Prevalence of parosmia
  • Not reported


Change in sense of taste
  • Not reported


Disease‐related quality of life
  • Not reported


Other adverse effects (including nosebleeds/bloody discharge)
  • Not reported


Other outcomes reported by the study:
  • Symptom dynamics ‐ assessed daily until 14 days. Symptoms assessed on day 14 by the physician with a VAS range 0 to 4, higher = worse. Considering sore throat, fever, rhinorrhoea, cough, nasal congestion. Other symptoms self reported by the patient will include rhinorrhoea, nasal congestion, rhinolalia, anosmia, sore throat, generation condition and fever. 

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.