Clinical efficacy of Luohua Anshen oral liquid in the treatment of short-term insomnia disorders (syndrome of depressed liver qi transforming into fire): protocol for a single-center, double-blinded, randomized, placebo-controlled trial

Abstract

Background: At present, insufficient attention and unsatisfactory treatment for short-term insomnia disorder are widespread problems. This group of people should receive safe and effective treatment as soon as possible and avoid developing into chronic insomnia disorder. We hope to intervene and treat these patients through Luohua Anshen oral Liquid, which is made of peanut branches and leaves and has been used to effectively treat insomnia disorder, this method can be conducive to preventing short-term insomnia disorder chronicity and reducing the burden of health economics. Methods: This double-blinded, randomized, placebo-controlled trial will be conducted at Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine. After the one-week baseline, 96 short-term insomnia patients will be allocated 1:1:1 to intervention group A (treatment with Luohua Anshen oral liquid placebo 30 min after breakfast, and Luohua Anshen oral liquid 30 min before retiring for sleep),intervention group B (treatment with Luohua Anshen oral Liquid 30 min after breakfast, and Luohua Anshen oral liquid placebo 30 min before retiring for sleep) or the control group (treatment with oral placebo twice a day), with 4 weeks of treatment and 12 weeks of follow-up. The primary outcome will be evaluated with the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes included the incidence of chronic insomnia, the Insomnia Severity Index (ISI), Traditional Chinese Medicine Syndrome Scale (TCMSS) and Morning and Evening Questionnaire-5 (MEQ-5) scores; the sleep parameters recorded in the GENEActiv and Sleep Diary;and the Hamilton Rating Scale for Depression (HAMD-17) and Hamilton Anxiety Scale (HAMA) scores. The mechanistic evidence will be full-spectrum detection via serum and fecal sample metabolomics. Discussion: This study provides more subjective and objective evidence of the efficacy and safety of Luohua Anshen oral liquid for improving sleep quality and exploreing the metabolic pathway of Serum and feces in patients with short-term insomnia. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (ChiCTR) (Identifier: ChiCTR2300071930) on 30 May 2023.