Authors
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The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine -More
Category
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Primary study
Registry of Trials»Chinese Clinical Trial Register
Year
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2026
INTERVENTION: Experimental Group A: Intervention group treated with Shugan Ningming Formula:Bupleuri Radi X12 g, Sojae Semen Preparatum 15 g, vinegar‐processed Cyperi Rhizoma 15 g, Chuanxiong Rhizoma 18 g, Citri Sarcodactylis Fructus 10 g, Perillae Folium 10 g, Poria cum Radi XPini 30 g, Poria Cocos 15 g, raw Atractylodis Macrocephalae Rhizoma 30 g, bran‐fried Atractylodis Macrocephalae Rhizoma 15 g, Polygoni Multiflori Caulis 15 g, Albiziae Corte X30 g, fried Ziziphi Spinosae Semen 15 g, Margaritifera Concha 30 g, Jujubae Fructus 6 g, roasted Glycyrrhizae Radi Xet Rhizoma 6 g. All medicinal materials were provided by the TCM Pharmacy of The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The herbal liquid was decocted by an automatic herbal decoction machine. Each prescription was made into 400 mL of decoction, which was warmly administered in two divided doses in the morning and evening respectively, with one dose taken daily for 4 consecutive weeks.;Experimental Group B: Five‐Tone Imagery Therapy Group:This group adopted a hospital‐home continuous treatment model. Home‐based Intervention Patients were instructed to conduct the intervention before bedtime each night in the supine position. They listened to designated music in a natural relaxed state and gradually entered a pre‐sleep state, with a fixed listening duration of 20 minutes per night for 4 consecutive weeks. Hospital‐based Intervention The operation was performed by professional personnel with official technical training certificates. Patients were placed in the supine position; targeted music was selected and played to help them rest calmly and peacefully. Professionals guided patients to establish imagery thinking, activate multi‐sensory pathways, and integrate with previous pleasant CONDITION: Tinnitus PRIMARY OUTCOME: Tinnitus Disability Scale; SECONDARY OUTCOME: Anxiety Self‐Rating Scale;The balance degree of the sympathetic and parasympathetic nerves in the resting state;Pure tone audiometry test; INCLUSION CRITERIA: 1. Tinnitus was the primary complaint, with a disease duration of = 3 months, and it met both the Western medical diagnostic criteria and the traditional Chinese medicine diagnosis criteria for liver depression and spleen deficiency type tinnitus. 2. In the past 1 month, no any treatment for tinnitus has been received from either Western or traditional Chinese medicine. 3. Age ranging from 18 to 70 years old, with no gender restrictions. 4. THI score = 21 points, and either the Self‐Rating Anxiety Scale (SAS) score = 50 points, or the LF/HF ratio (low‐frequency power / high‐frequency power) of the balance between sympathetic and parasympathetic nerves at rest = 2.0. 5. Possess normal reading, writing and language communication abilities, and can cooperate with the assessment, treatment and follow‐up during the study period. 6. Voluntarily participate in this study, and have signed the written informed consent form.
Epistemonikos ID: 0c7c8605f3756da6346f2495277890069ac6b049
First added on: Jun 06, 2026