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Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression

Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression

  1. NeuroChi
    The objective of this study was to assess the efficacy and safety of standardized extract SHR-5 of
    rhizomes of Rhodiola rosea L. in patients suffering from a current episode of mild/moderate
    depression. The phase III clinical trial was carried out as a randomized double-blind placebocontrolled
    study with parallel groups over 6 weeks. Participants, males and females aged 18
    70 years, were selected according to DSM-IV diagnostic criteria for depression, the severity of
    which was determined by scores gained in Beck Depression Inventory and Hamilton Rating
    Scale for Depression (HAMD) questionnaires. Patients with initial HAMD scores between 21
    and 31 were randomized into three groups, one of which (group A: 31 patients) received two
    tablets daily of SHR-5 (340 mg/day), a second (group B: 29 patients) received two tablets twice
    per day of SHR-5 (680 mg/day), and a third (group C: 29 patients) received two placebo tablets
    daily. The efficacy of SHR-5 extract with respect to depressive complaints was assessed on days 0
    and 42 of the study period from total and specific subgroup HAMD scores. For individuals in
    groups A and B, overall depression, together with insomnia, emotional instability and
    somatization, but not self-esteem, improved significantly following medication, whilst the
    placebo group did not show such improvements. No serious side-effects were reported in any of
    the groups AC. It is concluded that the standardized extract SHR-5 shows anti-depressive
    potency in patients with mild to moderate depression when administered in dosages of either 340
    or 680 mg/day over a 6-week period.