Shuhe granule for insomnia: study protocol for a double-blind, randomized, placebo-controlled trial

Area of Science:

• Integrative Medicine
• Clinical Pharmacology
• Sleep Medicine

Background:

• Conventional insomnia treatments face challenges including addiction, drug resistance, and relapse.
• Shuhe granule (SHG), a Chinese medicine formula, is used for insomnia but lacks robust clinical trial evidence.
• There is a need for high-quality evidence to support the use of SHG in insomnia management.

Purpose of the Study:

• To assess the efficacy and safety of Shuhe granule (SHG) in treating insomnia.
• To provide evidence-based data on the clinical utility of SHG for insomnia.
• To compare SHG with placebo in a randomized controlled trial setting.

Main Methods:

• A single-center, double-blind, randomized, parallel group, placebo-controlled trial.
• 160 eligible patients aged 18-65 will be randomized to receive either SHG or placebo.
• Outcomes will be assessed over 2 months, with primary focus on Insomnia Severity Index and secondary measures including sleep quality, fatigue, and mood.

Main Results:

• This section is to be populated upon study completion.
• Expected results will detail the efficacy and safety profile of SHG for insomnia.
• Data will be analyzed to determine the impact of SHG on primary and secondary outcome measures.

Conclusions:

• This study is expected to yield high-quality evidence on the efficacy and safety of SHG for insomnia.
• Findings will inform clinical practice regarding the use of SHG in insomnia treatment.
• The results will contribute to the evidence base for traditional Chinese medicine in managing sleep disorders.