A Randomized Controlled Study of Umbilical Acupuncture Treatment of Chronic Insomnia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044976

Enrollment

Unknown

Registered

2021-04-03

Start date

2021-04-15

Completion date

Unknown

Last updated

2021-11-02

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

Conditions

Chronic Insomnia

Interventions

Control group 1:Sinuosi tablet simulation agent, 10mg, qd (taken before going to bed) + fake acupuncture, 3 times a week, once every other day (Sinosi 5mg, PRN)

Control group 2:Sinuosi tablets, 10mg, qd (taken before going to bed) + fake acupuncture, 3 times a week, once every other day (sinuosi 5mg, PRN)

Experimental group 1:Simuosi tablet simulation agent, 10mg, qd (taken before going to bed) + umbilical needle, 3 times a week, once every other day (Sinosi 5mg, PRN)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years; 2. Meet the diagnostic criteria of chronic insomnia in western medicine; 3. Pittsburgh Sleep Quality Index (PSQI) total score > 7; 4. Stable vital signs, clear consciousness, and certain expression skills; 5. No antidepressant, anti-anxiety drugs, benzodiazepines, or non-benzodiazepine drugs have been used within 2 weeks before receiving intervention measures; 6. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are planning to become pregnant, pregnant or breastfeeding, or need to accompany their children to sleep together; 2. According to the medical history and consultation, the doctor confirms the secondary insomnia caused by other diseases, for example, local pain, restless legs syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis; 3. According to the self-assessment tool for depression (PHQ-9), patients with moderate or severe depression (total score >= 10) were diagnosed; 4. Diagnose moderate and severe anxiety patients (total score >=10) according to the Generalized Anxiety Scale (GAD-7); 5. Patients with serious diseases such as cardiovascular, cerebrovascular, lung, liver, kidney and endocrine system; 6. Patients with mental retardation, alcohol or substance abuse or dependence, or suicidal tendency; 7. Patients who have participated in other drug clinical trials in the past 30 days; 8. Patients with other mental illnesses; 9. Patients with unstable vital signs; 10. Severe aphasia, ignorance and unable to communicate; 11. Patients with umbilical hernia or coagulopathy; 12. Patients who have experience in umbilical acupuncture treatment. 13. Patients who are allergic to Sinos and alcohol.

Design outcomes

Primary

Measure	Time frame
PSQI score;	—

Secondary

Measure	Time frame
Sleep diary;ISI;PHQ-9;	—

Countries

China

Contacts

Public ContactYang Zhimin

Guangdong Provincial Hospital of Chinese Medicine

yangyovip@126.com+86 13822296363

Outcome results

None listed

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