Clinical effect of pestle needle combined with low-frequency repetitive transcranial magnetic stimulation on patients with chronic insomnia disorder and the influence of 5-HT and IL-6 levels in serum

Influence of different acupoint compatibility of "Li Zhongyu clubbing needle Therapy" on insomnia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080225

Enrollment

Unknown

Registered

2024-01-24

Start date

2024-01-30

Completion date

Unknown

Last updated

2024-01-28

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

Conditions

chronic insomnia

Interventions

Drug control group:Estazolam

Pestle needle group:Pestle needle

Low frequency repetitive transcranial magnetic stimulation group:Low frequency repetitive transcranial magnetic stimulation group

Pestle needle + low frequency repetitive transcranial magnetic stimulation group:Pestle needle + low frequency repetitive transcranial magnetic stimulation

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) In line with the diagnostic criteria of chronic insomnia; (2) 18 years = age =60 years, 3 months = duration =18 months, regardless of gender; (3) Pittsburgh Sleep Quality Index (PSQI) score > 7; (4) did not take any sleep medication two weeks before the start of the trial; (5) no comprehension and cognitive dysfunction, can fully understand the scale and cooperate with the intervention; (6) I know and agree to the relevant research content, signed the informed consent;

Exclusion criteria

Exclusion criteria: (1) Insomnia caused by alcohol and/or psychotropic substance abuse and dependence; (2) insomnia with other sleep disorders such as sleep apnea syndrome and serious physical diseases; (3) Patients with heart, lung, liver, kidney and other vital organ failure and malignant tumors; (4) Scalp damage, skin disease or metal implantation in the body, not suitable for pestle needle and rTMS treatment; (5) Pregnant or planning to become pregnant or breastfeed; (6) Patients with moderate to severe Anxiety and Depression symptoms (Self-rating Anxiety Scale (SAS) =60, Self-rating Depression Scale (SDS) =63);

Design outcomes

Primary

Measure	Time frame
Clinical total effective rate;The sleep monitor band monitors the indicators;Insomnia Severity Index;Pittsburgh Sleep Quality Index;	—

Secondary

Measure	Time frame
The MOS Item Short From Health Survey;Self-rating Depression Scale;Self-rating Anxiety Scale;National Sleep Foundation Sleep Diary;	—

Countries

China

Contacts

Public ContactSong Jin

Hospital of Chengdu University of Traditional Chinese Medicine

ss169188ss@163.com+86 132 1901 9006

Outcome results

None listed

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