A single-center, double-blind, randomized, placebo-controlled clinical study of Shuhe granule in the treatment of chronic insomnia with qi-blood disharmony and deficiency of both heart and kidney

Authors
Category Primary study
Registry of TrialsITMCTR
Year 2024
INTERVENTION: Control group:placebo; CONDITION: insomnia PRIMARY OUTCOME: The total socres of Insomnia Severity Index (ISI); SECONDARY OUTCOME: Syndrome score of traditional Chinese medicine;Generalized anxiety Disorder scale (GAD‐7);Visual analogue fatigue score (VFAS);The total scores and the various scores of the Pittsburgh sleep quality index;Syndrome score of traditional Chinese medicine;Patient Health Questionnaire(PHQ‐9);Fatigue severity scale (FSS); INCLUSION CRITERIA: (1) 18 to 65 years of age. (2) meet the diagnostic criteria of chronic insomnia in western medicine. (3) meet the diagnostic criteria of insomnia in traditional Chinese medicine. (4) consistent with the syndrome of disharmony between qi and blood and deficiency of both heart and kidney. (5) sign the informed consent form.
Epistemonikos ID: 9de9d12ae4e0e08a81c7aaea83c77a5a82438022
First added on: Aug 28, 2024