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Evidence of global relevance

The Study of Efficacy and Safety of a Modified Chaihu Shugan San Formula in the Treatment of Insomnia Associated with Stress: A Pilot Clinical Evaluation

A 30-participant pre-post pilot reported lower sleep-quality and stress scores after four weeks of twice-daily modified Chaihu Shugan San, without clear liver or renal safety signals. Without randomization, a control group, or placebo, the study cannot separate the formula's effect from placebo, attention, or change over time.

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Key findings

  • Mean PSQI decreased from 12.300±3.164 to 6.833±4.145 (p
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Why this matters globally

The study offers an initial signal and measurable outcomes for designing controlled trials of a traditional Chinese formula for sleep, but it is insufficient for clinical recommendations or efficacy claims.

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Thai researcher contribution

Teams from Chandrakasem Rajabhat University and Nakhonratchasima College placed a traditional Chinese medicine formula within a structured evaluation using standardized scores and laboratory safety monitoring.

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Limitations to consider

The sample was small (n=30) and purposively selected, with no randomization, blinding, control, or placebo. Four weeks is too short to assess durability, rare adverse events, drug interactions, or long-term safety, and outcomes were largely self-reported.

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Verify the original sources

International Journal of Drug Delivery TechnologyRead the original article

DOI: 10.25258/ijddt.16.61s.10

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