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A Clinical and Comparative Study with Randomly Selected Samples of the Effect of Abdominal Acupunctre Combined with Estazolam-Withdrawal Therapy on Estazolam Dependent Insomnia with Mild Anxiety and Depression

A Clinical and Comparative Study with Randomly Selected Samples of the Effect of Abdominal Acupunctre Combined with Estazolam-Withdrawal Therapy on Estazolam Dependent Insomnia with Mild Anxiety and Depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004541
Enrollment
Unknown
Registered
2020-12-23
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Drug dependent insomnia

Interventions

Sponsors

Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1, Diagonized (by Traditional Chinese medicine and modern medicine) as insomina and drug dependent insomnia, taking Estazolam 1-2mg (per day) over 6 months, right-handed; 2, being conscious, without aphasia and other distrubance of intelligence, being able to understand questions in scales and cooperate with the treatment; 3, scoring 7 or more on the Pittsburgh Sleep Quality Index; 4, without severe physical or mental diseases (e.g., cordio-vascular diseases, kidney deficiencies, etc.); 5. in the age of 40 to 65, being willing to accept and comply with the treatment; 6, taking part voluntarily with signature on the informed consent; 7, scoring from 7 to 21 on HAMA; 8, scoring more than 7 and less than or equal to 17 on HAMD.

Exclusion criteria

Exclusion criteria: 1. Taking medicine other than Estazolam in treating insomnia; 2. with insomnia induced by (other) medicines, emergencies, ill habits, and/or other environmental/phychological factors; 3. with insomnia induced by severe neurasthenia,stress disorder,personality disorder, other physical diseases and/or psychoactive substances; 4. judged by the researcher(s) as having other conditions which may interfere with the conduct of research (e.g., patients whose working conditions change frequently or who travel frequently); 5. being pregnant, being in lactation, with ??, and/or with ??????; 6. with severe liver and/or kidney deficiencies, and/or ?????????; 7. with alcoholism and/or other substance-dependencies; 8. being unable to comply with the treatment due to any external reasons; 9. being allergic to rubbing alcohol and/or acupuncture; 10. being in conditions which may interfere with abdominal acupuncture (i.e., diseases in abdominal organs, scars on abdomen, etc.); 11. Taking any other treatment and/or clinical research currently. Patients who have one or more conditions listed above are not qualified as subjects of this research.

Design outcomes

Primary

MeasureTime frame
estazolem intake;rate of estazolem reduction;Pittsburgh sleep quality index;

Secondary

MeasureTime frame
HAMA;BWSQ;assessment of safety;EEG;HAMD;

Countries

China

Contacts

Public ContactWang Jing

Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine

happyksg@126.com+86 15910525655

Outcome results

None listed

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