Evaluation of clinical efficacy of Tibetan medicine ''Shiyiwei Weiming Capsule'' in the treatment of insomnia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052292

Enrollment

Unknown

Registered

2021-10-24

Start date

2021-11-01

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Insomnia

Interventions

Experimental group:Shiyiwei Weiming Capsule

Control group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the ICD-10 diagnostic criteria for insomnia; 2. There is no gender limit, and aged between 18-65 years (including 18 and 65 years old); 3. All subjects voluntarily participated in the clinical trial research and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Any lifestyle that interferes with the test process or may interfere with sleep: for example, in the last two weeks or during the test period, there will be travel across time zones or shift work (night shift and day shift), etc.; 2. Special professionals who need to operate machinery during the test period, such as professional drivers, high-altitude operators, etc.; 3. Those who regularly drink too much tea and coffee every day; 4. Insomnia caused by other diseases such as: narcolepsy, respiratory related sleep disorder, etc.; 5. Patients with tumor, myocardial infarction, heart failure, mental disorder history, drug abuse history, drug addiction history in the past year; 6. Patients with impaired heart, liver, kidney and respiratory function or other serious diseases of various systems, AST or ALT exceeding 1.5 times the upper limit of normal, and serum creatinine exceeding the upper limit of normal; 7. The HAMA anxiety scale score is greater than 14 points, and the HAMD depression scale score is greater than or equal to 17 points at the time of screening; 8. Special groups: allergic constitution, pregnant women, pregnant or breastfeeding women, allergic to the ingredients of this drug; 9. Patients who participated in other clinical studies within 3 months; 10. Patients with apnea; 11. After enrollment, patients taking patients who affect wake-up and sleep function or affect the evaluation of test drugs.

Design outcomes

Primary

Measure	Time frame
Brain fluctuation map;Polysomnography;Pittsburgh sleep scale;General rating scale;Depression scale;HAMA anxiety scale;	—

Countries

China

Contacts

Public ContactRenqing Dongzhu

Qinghai Jiumei Tibetan Hospital Co. , Ltd.

rqdz@yahoo.com+86 15297189073

Outcome results

None listed

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