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Randomized controlled trial and preliminary exploration of fNIRS mechanism in the treatment of acute idiopathic tinnitus using the "Tiaoshen Jingming Acupuncture Method"

Randomized controlled trial and preliminary exploration of fNIRS mechanism in the treatment of acute idiopathic tinnitus using the "Tiaoshen Jingming Acupuncture Method"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000043
Enrollment
Unknown
Registered
2026-01-09
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Acute tinnitus

Interventions

experimental group:Conventional Western Medicine+"Tiaoshen Jingming Acupuncture Method"

Sponsors

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for acute idiopathic tinnitus and has a tinnitus handicap inventory score of = 18 points; (2) Has good compliance, aged 18 to 65 years old, regardless of gender; (3) Acute stage of tinnitus, i.e. tinnitus duration = 3 months; (4) Willing to accept acupuncture treatment and able to cooperate in completing the tinnitus assessment scale; (5) All subjects with fertility (regardless of gender) agree to take effective contraceptive measures (such as oral contraceptives or intrauterine devices) during the study period; (6) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Secondary tinnitus caused by a clear etiology (such as sudden deafness, otitis media, acute phase of Meniere's disease, acoustic neuroma, temporomandibular joint disorder, cranial surgery, head trauma, etc.); (2) Merge with severe primary diseases such as heart, liver, kidney, hematopoietic system, or malignant tumors, where liver and kidney related indicators exceed the upper limit of normal by 1.5 times; (3) Pregnant or lactating women; (4) For those who have contraindications or allergies to Western medicine used in routine research, including: 4a. Individuals allergic to methylcobalamin and Ginkgo biloba extract; 4b. Individuals who are allergic to SSRIs (such as sertraline, paroxetine, etc.), benzodiazepines (such as alprazolam, lorazepam, etc.), or other sedatives intended for use; 4c. Those who are currently undergoing treatment with monoamine oxidase inhibitors (MAOIs) or have stopped taking the medication for less than 2 weeks (prohibited from being used in combination with SSRIs); 4d. Individuals with glaucoma, a history of epilepsy, or unstable epilepsy; Or those who are allergic to metals; (5) Subjects who cannot cooperate with treatment or have poor compliance; (6) Those who have participated in other clinical trials (including acupuncture and moxibustion) in the past month. (7) Those who regularly receive acupuncture and moxibustion and traditional Chinese medicine treatment in the past month; (8) If accompanied by emotional sleep problems, the severity is severe: Self Rating Anxiety Scale (SAS)>70 points; The Self Rating Depression Scale (SDS) score is greater than 73 points; Pittsburgh Sleep Quality Index (PSQI)>15 points; (9) Acupuncture for patients with local skin damage, infection, or skin diseases; (10) Individuals with a history of needle dizziness; (11) Those diagnosed with diabetes, hypertension and poor control, (12) After evaluating the status, the researchers deemed it unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
tinnitus handicap inventory;

Secondary

MeasureTime frame
Visual Analog Scale;Self-Rating Anxiety Scale;Self-rating Depression Scale;Pittsburgh Sleep Quality Index;

Countries

China

Contacts

Public ContactZhi Mingjie

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

drzimingjie@126.com13621052996

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026