A Randomized Controlled Study of Umbilical Acupuncture Treatment of Chronic Insomnia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100004682

Enrollment

Unknown

Registered

2021-04-03

Start date

2021-04-15

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

Chronic Insomnia

Interventions

Test 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)

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)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) 18-60 years old; (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) People 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) Those with serious diseases such as cardiovascular, cerebrovascular, lung, liver, kidney and endocrine system; (6) People with mental retardation, alcohol or substance abuse or dependence, or suicidal tendency; (7) Those who have participated in other drug clinical trials in the past 30 days; (8) People with other mental illnesses; (9) People with unstable vital signs; (10) Severe aphasia, ignorance and unable to communicate; (11) People with umbilical hernia or coagulopathy; (12) Those who have experience in umbilical acupuncture treatment. (13) People 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 ContactZhimin Yang

yangyovip@126.com13822296363

Outcome results

None listed

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