Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms
Status:
Recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
This study is a randomized, placebo-controlled, double-blind clinical study. 60 cases of
insomnia patients with depressive symptoms are planned to be treated, and they are randomly
assigned to the experimental group (Shugan Jieyu Capsule combined with zolpidem group) and
the control group (placebo combined with zolpidem group) in equal proportion. Both groups are
given zolpidem orally for basic treatment, with the treatment dose of 10mg per tablet per
day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. The test group
was given Shugan Jieyu Capsule orally, with a therapeutic dose of 0.36g per capsule, 2
capsules each time, twice a day, and once after breakfast and dinner. The control group was
given placebo orally, with a treatment dose of 0.36g per capsule, 2 capsules each time, twice
a day, and once after breakfast and dinner. The therapeutic effect of Shugan Jieyu Capsule on
insomnia patients with depressive symptoms was observed by analyzing the changes of ISI
scores, subjective and objective sleep indicators (PSG, sleep diary), daytime cognitive
function, autonomic nervous function and EEG after the intervention in the fourth and eighth
weeks.