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Clinical study of rectal ozone perfusion therapy on stopping after long-term use of benzodiazepines-participants' blind, randomized and controlled trial

Clinical study of rectal ozone perfusion therapy on stopping after long-term use of benzodiazepines-participants' blind, randomized and controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097359
Enrollment
Unknown
Registered
2025-02-18
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

sleep disorders

Interventions

experimental group:Rectal trioxygen perfusion CBT-I rTMS Chinese medicinal therapy SGB
Basic treatment group :CBT-I rTMS Chinese medicinal therapy SGB

Sponsors

The Fifth People's Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18-75 years old, gender not specified; (2) Experiences at least 3 nights of insomnia per week for at least 1 month, which meets the diagnostic criteria for transient insomnia disorder as stipulated in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition); (3) Has completed at least 9 years of formal education; (4) Has taken benzodiazepine or non-benzodiazepine sleeping pills for more than 4 weeks and is willing to reduce or stop taking the medication.

Exclusion criteria

Exclusion criteria: (1) Severe intestinal conditions (such as anal fissures, hemorrhoids, etc.) or a history of intestinal surgery (2) Severe coagulation disorders (3) Having an implanted pacemaker or other electronic implants (4) Having other mental health conditions (such as bipolar disorder, schizophrenia, obsessive-compulsive disorder) (5) Allergy to local anesthetics

Design outcomes

Primary

MeasureTime frame
Discontinuation of BZDs at the end of treatment, week 4, week 8, and week 12;Equivalent dose and weekly frequency of diazepam;

Secondary

MeasureTime frame
Insomnia Severity Index;Pittsburgh Sleep Quality Index;Self-rating scale of somatization symptoms;BZDs Withdrawal Symptoms Questionnaire;Hamilton Anxiety and Depression Scale;Epworth Sleepiness Scale;Hospital Anxiety and Depression Scale;Functional near-infrared spectroscopy;Polysomnography;

Countries

China

Contacts

Public ContactYin Hong

The Fifth People's Hospital of Chengdu

doctoryh@126.com+86 180 3056 2908

Outcome results

None listed

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