ChiCTR2600123965 版本V1.0 版本创建时间2026/05/05 23:30:17 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600123965 

最近更新日期：

Date of Last Refreshed on：

 2026-05-05 23:30:12 

注册时间：

Date of Registration：

 2026-05-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于“调神”思想运用舒肝宁鸣方联合五音具象疗法治疗肝郁脾虚型耳鸣的临床疗效观察及机制研究

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“调神”思想运用舒肝宁鸣方联合五音具象疗法治疗肝郁脾虚型耳鸣的临床疗效观察及机制研究

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张铭倩 

研究负责人：

周霞 

Applicant：

Zhang Mingqian 

Study leader：

Zhou Xia 

申请注册联系人电话：

Applicant telephone：

 +86 135 6310 1197

研究负责人电话：

Study leader's
telephone：

+86 135 6310 1197

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 tzlmingqian@163.com

研究负责人电子邮件：

Study leader's E-mail：

 tzlmingqian@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

山东省济南市长清区大学路4655

研究负责人通讯地址：

山东省济南市市中区经八路1号

Applicant address：

University Road, Changqing District, Jinan City, Shandong Province, 465

Study leader's address：

No. 1, Jingsi Road, Shizhong District, Jinan City, Shandong Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

山东中医药大学

Applicant's institution：

Shandong University of Traditional Chinese Medicine

研究负责人所在单位：

山东中医药大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2026伦审-XS-015

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

山东中医药大学第二附属医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-17 00:00:00

伦理委员会联系人：

袁媛

Contact Name of the ethic committee：

Yuan Yuan

伦理委员会联系地址：

山东省济南市市中区经八路1号

Contact Address of the ethic committee：

No. 1, Jingsi Road, Shizhong District, Jinan City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 58261060

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

山东中医药大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

山东省济南市市中区经八路1号

Primary sponsor's address：

No. 1, Jingsi Road, Shizhong District, Jinan City, Shandong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东中医药大学第二附属医院

具体地址：

山东省济南市市中区经八路1号

Institution
hospital：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address：

No. 1, Jingsi Road, Shizhong District, Jinan City, Shandong Province

经费或物资来源：

课题经费

Source(s) of funding：

Research funding

研究疾病：

耳鸣  

Target disease：

Tinnitus

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

耳鸣是临床常见症状，现代医学缺乏特效疗法，患者易陷入“耳鸣-焦虑”恶性循环。中医认为，肝郁脾虚是耳鸣重要病机，肝失疏泄、脾不升清导致耳窍失养。研究基于“调神”理论，提出以“舒肝宁鸣方”疏肝健脾、安神定志，同时联合“五音具象疗法”，通过角调、宫调音乐结合具象引导，实现音药协同、身心同治。该综合方案旨在突破常规治疗局限，为肝郁脾虚型耳鸣提供一种融合药物、音乐与心理调节的创新策略。目前，该形神共调的综合干预模式尚缺乏系统临床验证。因此，本研究拟通过规范临床试验，评价其疗效与安全性，为耳鸣的中医心身综合诊疗提供高级别循证依据。  

Objectives of Study：

Tinnitus is a prevalent clinical symptom with no specific and efficacious treatments in modern medicine, and affected patients are susceptible to a vicious cycle of "tinnitus-anxiety". From the perspective of traditional Chinese medicine (TCM), liver depression and spleen deficiency is a crucial pathogenesis of tinnitus. Liver dysfunction in dispersion and conveyance as well as failure of the spleen to ascend clear qi results in malnourishment of the ear orifices.Based on the TCM theory of "spirit regulation", this research adopts Shugan Ningming Formula to soothe the liver and invigorate the spleen, calm the mind and stabilize mood. Meanwhile, combined with the five-tone imagery therapy, Jue-mode and Gong-mode music are applied in conjunction with imagery guidance to realize the synergy of music and herbal medicine, as well as holistic physical and mental treatment. This comprehensive intervention aims to break the bottlenecks of conventional therapies and provide an innovative strategy integrating medication, music intervention and psychological regulation for tinnitus patients with liver depression and spleen deficiency pattern.Nevertheless, the systematic clinical validation of this body-spirit co-regulation model remains insufficient. Therefore, this study intends to carry out standardized clinical trials to evaluate the clinical efficacy and safety of the combined regimen, so as to furnish high-level evidence-based references for the psychosomatic integrated diagnosis and treatment of tinnitus in TCM practice.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 耳鸣为第一主诉，病程≤3个月，且同时符合西医诊断标准与中医肝郁脾虚型耳鸣诊断标准。 2. 最近1个月内未接受过任何针对耳鸣的中、西医治疗。 3. 18<=年龄<=70 周岁，性别不限。 4.THI评分>=21分，同时焦虑自评量表（SAS）>=50分，或静息状态下交感与副交感神经平衡度中LF/HF 比值（低频功率 / 高频功率）>=2.0。 5. 具备正常的阅读、书写及语言沟通能力，能配合完成研究期间的评估、治疗及随访。 6.自愿参与本研究，且已签署书面知情同意书。

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.

排除标准：

1. 不符合上述纳入标准。 2. 近3月存在干扰研究评估的治疗史或状态。 3.纯音听阈测试（PTA）＞65 dB HL 4. 合并严重精神或躯体疾病。 5.处于妊娠期、哺乳期的女性，或对本研究拟用药物过敏者等特殊人群。 6. 无法配合研究、依从性差（如大概率无法完成全程治疗与随访）的患者。

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).

研究实施时间：

Study execute time：

从 From 2026-04-17 00:00:00至 To 2027-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-06 00:00:00 至 To 2027-04-30 00:00:00

干预措施：

Interventions：

组别：

试验组A：舒肝宁鸣方试验组

样本量：

 22

Group：

Experimental Group A: Intervention group treated with Shugan Ningming Formula

Sample size：

干预措施：

舒肝宁鸣方组方：柴胡12g、淡豆豉15g、醋香附15g、川芎18g、佛手10g、紫苏叶10g、茯神30g、茯苓15g、生白术30g、麸炒白术15g、首乌藤15g、合欢皮30g、炒酸枣仁15g、珍珠母30g、大枣6g、炙甘草6g 所用药材均来自山东中医药大学第二附属医院中药房，采用煎药机煎取中药液。每剂煎取药液400ml，分早、晚2次温服，每日1剂，连续服用4周。

干预措施代码：

Intervention：

Bupleuri Radix 12 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 Radix Pini 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 Cortex 30 g, fried Ziziphi Spinosae Semen 15 g, Margaritifera Concha 30 g, Jujubae Fructus 6 g, roasted Glycyrrhizae Radix et 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.

Intervention code：

组别：

试验组B：五音具象疗法试验组

样本量：

 22

Group：

Experimental Group B: Five-Tone Imagery Therapy Group

Sample size：

干预措施：

本组采用医院-居家延续性治疗模式。 居家干预部分：要求患者于每晚临睡前实施，取仰卧位，在自然放松状态下收听意向音乐，并逐步进入睡眠准备状态，收听时长设定为20分钟，持续4周。 医院干预部分：由已获得相关技术培训证书的专业人员作为施术者，帮助患者取仰卧位，选中并播放意向音乐，令患者松静安卧，帮助其建立具象思维体验，引导患者打开多感观通道并与过往轻松愉快体验相结合，逐步进入身心放松状态。保持已建立的具象体验同时，施术者实施头面点穴，调动触觉、激活督脉相关穴位，进一步放松身心，达到特定状态（催眠态）。具体操作手法参照《五音具象催技术规范》。每次干预时长30分钟，每日1次，每周5次，持续4周。 调式选择：音乐调式需依据证候的偏重进行选择。若患者肝郁证候表现显著，重于脾虚症状，则予角调音乐，以疏肝解郁、调畅气机；若脾虚证候更为突出，重于肝郁症状，则予宫调音乐，以健脾和胃、安养中州。所选乐曲均源自周霞主任门诊临床常用音乐库，收录于“自天真”小程序，为经过实践验证的有效方案。 音乐强度：音乐强度范围在 20 dB～60 dB，根据受访者听力敏感度选用合适的强度，以可轻松听见又不觉刺耳为宜。 五音播放器选用Sansui，设备型号：山水，F55。

干预措施代码：

Intervention：

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 and relaxing experiences, so as to achieve gradual physical and mental relaxation. While maintaining the imagery experience, operators conducted head and facial acupoint pressing to stimulate tactile perception and activate acupoints of the Governor Vessel, further relieving physical and mental tension and inducing a hypnotic state. All operational procedures were implemented in strict accordance with the Technical Specifications for Five-Tone Imagery Hypnosis. Each intervention lasted 30 minutes, once a day, five times a week, for 4 consecutive weeks. Musical Mode Selection Musical modes were chosen based on the severity of TCM syndromes. For patients with dominant liver depression symptoms that outweigh spleen deficiency manifestations, Jue-mode music was applied to soothe the liver, relieve stagnation and regulate qi activity. For patients with prominent spleen deficiency symptoms severer than liver depression, Gong-mode music was adopted to invigorate the spleen, harmonize the stomach and nourish the middle jiao. All music materials were selected from the clinical music library routinely used in Director Zhou Xia’s outpatient department, included in the mini-program Zi Tianzhen, and all intervention protocols have been verified by clinical practice. Music Intensity The sound intensity was set within the range of 20 dB to 60 dB. The volume was adjusted individually according to patients’ hearing sensitivity, maintaining a comfortable audible level without harsh or irritating perception. Audio Equipment The five-tone music player used was Sansui F55.

Intervention code：

组别：

试验组C：舒肝宁鸣方联合五音具象疗法试验组

样本量：

 22

Group：

Experimental Group C: Combined group of Shugan Ningming Formula and Five-Tone Imagery Therapy

Sample size：

干预措施：

本组接受联合方案干预，在完全遵循A组舒肝宁鸣方治疗方案的基础上，同步接受与B组完全相同的五音具象疗法治疗方案。 为确保干预的纯粹性和可对比性，将五音具象疗法治疗安排在服药2小时后进行，以避免生理状态对其效果的干扰，同时保证两种干预均能独立、充分地发挥作用。

干预措施代码：

Intervention：

This group received combined intervention. On the premise of strictly following the medication protocol of Shugan Ningming Formula in Group A, patients simultaneously underwent the identical Five-Tone Imagery Therapy regimen as Group B. To ensure the purity and comparability of different interventions, the five-tone imagery therapy was arranged 2 hours after oral medication. This design avoids the interference of physiological status on therapeutic efficacy, and enables the two interventions to exert their effects independently and sufficiently.

Intervention code：

组别：

对照组：常规药物试验组

样本量：

 22

Group：

Control Group: Conventional Medication Group

Sample size：

干预措施：

给予患者甲钴胺片（弥可保），生产企业：卫材(中国)药业有限公司，国药准字H20030812，来自山东中医药大学第二附属医院西药房，口服，0.5mg/次，一日3次，连续服用4周。

干预措施代码：

Intervention：

Patients were administered Mecobalamin Tablets (Mexobal), manufactured by Eisai (China) Pharmaceutical Co., Ltd., National Drug Approval Certificate No. H20030812. The drugs were supplied by the Western Pharmacy of The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The dosage was 0.5 mg per oral administration, three times a day, for a continuous course of 4 weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

 济南 

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

 山东中医药大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

耳鸣残疾量表

指标类型：

主要指标

Outcome：

Tinnitus Disability Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Anxiety Self-Rating Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

静息状态下交感与副交感神经平衡度

指标类型：

次要指标

Outcome：

The balance degree of the sympathetic and parasympathetic nerves in the resting state

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

纯音听阈测试

指标类型：

次要指标

Outcome：

Pure tone audiometry test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由第三方人员采用基于中央随机系统的区组随机化方法进行随机

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomization was carried out by third-party personnel using the block randomization method based on the central random system.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

CRF;EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-05-05 23:30:12