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Clinical efficacy evaluation and related mechanism study of acupuncture intervention by "combination of Shu-Yuan acupoints" on insomnia with tinnitus of heart kidney disjunction type

Clinical efficacy evaluation and related mechanism study of acupuncture intervention by "combination of Shu-Yuan acupoints" on insomnia with tinnitus of heart kidney disjunction type

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000170
Enrollment
Unknown
Registered
2025-01-25
Start date
2024-09-26
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

insomnia with tinnitus

Interventions

Acupuncture group:Main acupoints: Shenmen, Taixi, Xinyu, Shenshu. Positioning: Refer to the 2021 National Standard of the People's Republic of China "Names and Positioning of Meridian Points" (GB/T 12
Comfort needle group:Intervention using a comforting flat headed needle. The selected acupoint is positioned 0.5 inches next to the selected acupoint in the treatment group avoiding the meridians of t

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age range from 18 to 65 years old regardless of gender; Meets the diagnostic criteria for chronic insomnia in ICSD-3; The diagnosis of tinnitus meets the clinical diagnostic criteria for subjective subacute or chronic tinnitus in adults according to the European Multidisciplinary Tinnitus Guidelines; PSQI = 5 points [4]; The severity of tinnitus THI is greater than 38 and the average hearing threshold of both ears is less than 35dbHL; The traditional Chinese medicine syndrome differentiation is divided into heart kidney non intersection type; Before entering this study stable use of sedative and hypnotic drugs for more than 3 months or no use of such drugs; Follow the principle of voluntariness and sign an informed consent form before entering the study.

Exclusion criteria

Exclusion criteria: Merge serious diseases such as heart liver kidney brain blood respiratory system etc; Patients with severe mental illness; Patients who have been diagnosed with other types of sleep disorders; Pregnant or lactating women; Infectious diseases; Other situations that cannot cooperate with clinical trials such as severe visual or language deficits.

Design outcomes

Primary

MeasureTime frame
PSQI;

Secondary

MeasureTime frame
ISI;Actigraphy sleep data;THI;Traditional Chinese Medicine Syndrome Scale;Beck Anxiety Inventory,BAI;MoCA;

Countries

China

Contacts

Public ContactChen Yunfei

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM

icyf1968@163.com+86 189 3067 8221

Outcome results

None listed

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