| Journal | Journal of cannabis research |
| Study Type | Randomized Trial |
| Population | Human participants |
This represents one of the first rigorous randomized controlled trials examining a traditional cannabis-based herbal formulation against an established sleep medication. The study provides preliminary clinical evidence for cannabis-containing preparations in insomnia management using validated sleep assessment tools.
This Phase II double-blind RCT compared a traditional Thai multi-herbal cannabis formulation to lorazepam in 100 patients with chronic insomnia over 4 weeks. The study used a non-inferiority design with PSQI as the primary outcome measure and a predefined margin of 2.1 points. Eighty-two participants completed the trial with 41 in each group. The study evaluated both efficacy through sleep quality measures and safety through clinical and laboratory assessments, though specific outcome data are not provided in this summary.
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Book a consultation →“While encouraging to see rigorous methodology applied to traditional cannabis preparations, I remain cautious about multi-herbal formulations where individual component contributions cannot be isolated. The non-inferiority design against lorazepam is clinically relevant, though we need the actual outcome data to assess clinical significance.”
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This study item was assembled from normalized source metadata and pipeline scoring.