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Clinical Observation and Mechanism Research on the Therapeutic Effect of Shugan Ningming Formula Combined with Five-tone Imagery Therapy Based on the "Regulating the Spirit" Thought in Treating Tinnitus of Liver Depression and Spleen Deficiency Type

Clinical Observation and Mechanism Research on the Therapeutic Effect of Shugan Ningming Formula Combined with Five-tone Imagery Therapy Based on the "Regulating the Spirit" Thought in Treating Tinnitus of Liver Depression and Spleen Deficiency Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123965
Enrollment
Unknown
Registered
2026-05-05
Start date
2026-05-06
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Interventions

Experimental Group A: Intervention group treated with Shugan Ningming Formula:Bupleuri Radix 12 g, Sojae Semen Preparatum 15 g, vinegar-processed Cyperi Rhizoma 15 g, Chuanxiong Rhizoma 18 g, Citri Sa
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
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 previou

Sponsors

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Does not meet the above inclusion criteria. 2. Has a history or condition that interferes with the assessment of the study within the past 3 months. 3. Pure tone audiometry (PTA) > 65 dB HL. 4. Has severe mental or physical diseases. 5. Pregnant women, lactating women, or individuals who are allergic to the drugs to be used in this study, etc., are special populations. 6. Patients who cannot cooperate with the study, have poor compliance (such as a high probability of not completing the entire treatment and follow-up).

Design outcomes

Primary

MeasureTime frame
Tinnitus Disability Scale;

Secondary

MeasureTime frame
Anxiety Self-Rating Scale;The balance degree of the sympathetic and parasympathetic nerves in the resting state;Pure tone audiometry test;

Countries

China

Contacts

Public ContactZhou Xia

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

tzlmingqian@163.com+86 135 6310 1197

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026