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Observation on the clinical efficacy of "Shugan Qingxin Tongdu Dingshen" acupuncture therapy in the treatment of chronic insomnia and its influence on stress regulation

Observation on the clinical efficacy of "Shugan Qingxin Tongdu Dingshen" acupuncture therapy in the treatment of chronic insomnia and its influence on stress regulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001276
Enrollment
Unknown
Registered
2025-06-26
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

chronic insomnia

Interventions

Treatment group:acupuncture

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old and 7 points; (5) PSS score =28 points; (6) Have been taking sedative-hypnotic drugs stably for more than 3 months or have not taken any drugs before entering this study; (7) Patients who have not received acupuncture treatment in the past three months; (8) The patient himself/herself signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Suffering from other organic diseases such as serious primary diseases of the cardiovascular liver kidney lung etc. Or accompanied by severe mental symptoms; (2) Pregnant or lactating women; (3) PSG shows that the Apnea-hypopnea Index (AHI) is =10 times /h; (4) PSG shows Periodic Limb Movements During Sleep (PLMS) > 15 times /h; (5) The score of the Hamilton Depression Scale (HAMD-17) is =24 points; (6) The score of the Hamilton Anxiety Scale (HAMA) is =21 points; (7) Have participated in or are currently participating in other clinical researchers within the 3 months prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Actigraphy;Insomnia Severity Index;Dysfunctional Beliefs and Attitudes about Sleep;The expression of FKBP5, NR3C1, AVP, BDNF, CRH and CNR1 genes in blood;Perceived Stress Scale;Serum levels of CRH, ACTH and CORT;Symptom and Syndrome Scale of Traditional Chinese Medicine;

Countries

China

Contacts

Public ContactYang Wenjia

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

yangwenjia1030@163.com15800690158

Outcome results

None listed

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