title: A parallel, randomized, double-blind, placebo-controlled study to investigate the effect of SagaPro on nocturia in men.
abstract: OBJECTIVE
  This study aimed to investigate the effect of SagaPro, a product derived from Angelica archangelica leaf, on nocturia.
  
  
  METHODS
  Sixty-nine male patients 45 years or older with at least two nocturnal voids were randomized to receive SagaPro or placebo in a double-blind design for 8 weeks. Voiding diaries were assessed before and after the treatment.
  
  
  RESULTS
  The results indicate that SagaPro is safe. The actual number of nocturnal voids (ANV), nocturnal polyuria index (NPi) and nocturnal bladder capacity index (NBC index) decreased in the test population, but there was no significant difference between the treatment groups. Subsequent subgroup analysis showed that SagaPro significantly reduced the NBC index and nocturnal voids per sleeping hour in comparison to the placebo in participants with baseline NBC index above 1.3. When participants with sleep disorders were excluded from this group, ANV was also significantly reduced for the SagaPro group in comparison to the placebo group.
  
  
  CONCLUSIONS
  SagaPro, made from an extract of the medicinal herb Angelica archangelica, is safe. This study did not show that SagaPro improved nocturia overall compared to placebo. Subgroup analysis suggested a beneficial effect in individuals with decreased nocturnal bladder capacity, which warrants further study.
authors: SagaMedica, Reykjavik, Iceland. steinthor@sagamedica.is
authors: Steinthor
authors: S
authors: Sigurdsson
authors: Gudmundur
authors: G
authors: Geirsson
authors: Hrefna
authors: H
authors: Gudmundsdottir
authors: Perla B
authors: PB
authors: Egilsdottir
authors: Sigmundur
authors: S
authors: Gudbjarnason
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D029970:Angelica archangelica; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D053158:Nocturia / Q000188:drug therapy* / Q000453:epidemiology; D061214:Patient Safety; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D018515:Plant Leaves; D015995:Prevalence; D012892:Sleep Deprivation / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts