Study of Modified Suan ZaoRen Tang-TianWang BuXin Dan Granules for Treating Chronic Insomnia Randomized, Double-blinded, Placebo-controlled Trial in Adults 18 to 65

What this Trial Is About

This research aims to evaluate the effects of a modified Chinese herbal formula combining Suan Zao Ren Tang and Tian Wang Bu Xin Dan in treating chronic insomnia. The trial is a randomized, double-blinded, placebo-controlled study involving adults aged 18 to 65 diagnosed with insomnia according to clinical criteria and traditional Chinese Medicine patterns. Insomnia is a common sleep disorder characterized by difficulty falling or staying asleep, affecting daily life for many individuals. Participants will be randomly assigned to receive either the modified herbal granules or placebo granules daily for 6 weeks. After completing the treatment period, a follow-up visit will occur at week 9. The study monitors changes in sleep quality and insomnia symptoms using the Pittsburgh Sleep Quality Index PSQI and Insomnia Severity Index ISI, among other scales. Both treatment and placebo are given as granules, and participant responses are assessed throughout. During the trial, participants will complete questionnaires to evaluate sleep quality, insomnia severity, and anxiety or depression symptoms at baseline, week 3, week 6, and week 9. Researchers will monitor safety and adherence, with primary focus on the change in PSQI score at week 6. The total participation includes 6 weeks of treatment and a post-treatment assessment at week 9. The study is sponsored by the Chinese University of Hong Kong.

Chinese Medicine in Treating Insomnia