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 Depressio
- Conditions
- Drug dependent insomnia
- Registration Number
- ITMCTR2100004541
- Lead Sponsor
- Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method estazolem intake;rate of estazolem reduction;Pittsburgh sleep quality index;
- Secondary Outcome Measures
Name Time Method HAMA;BWSQ;assessment of safety;EEG;HAMD;