NCT06511011

Chinese Medicine in Treating Insomnia

Efficacy and Safety of Modified Suan ZaoRen Tang-TianWang BuXin Dan in the Treatment of Chronic Insomnia: A Randomized, Double-blinded, Placebo-controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blinded, placebo-controlled clinical trial. Eligible participants will randomized into either treatment group (CM granules) or placebo group (placebo granules) for 6 weeks, followed by a post-treatment visit at week 9. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) at week 6.

Detailed description

Insomnia is one of the most general health concerns in the society. It is generally defined as a self-reported sleep disorder problem of the patient, characterized by difficulty in falling asleep, or difficulty maintaining sleep. According to American Insomnia Survey, 42.6% of the respondents reported of having at least one of the insomnia symptoms. Chinese medicine can be an alternative to the treatment of insomnia. Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia, for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind, clear heat and alleviate vexation, and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind, and nourish Yin and clear heat. In this study, we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan, and observe the effectiveness and safety of the study drug.

Conditions

• Insomnia Chronic

Interventions

Type	Name	Description
DRUG	Modified Suan ZaoRen Tang-TianWang BuXin Dan	Chinese medicine granules for 6 weeks
DRUG	Placebo	Placebo granules for 6 weeks

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2024-07-19
• Last updated: 2024-07-25