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A prospective randomized double blind controlled clinical study of Qinggan Jieyu granula in the treatment of primary insomnia

A prospective randomized double blind controlled clinical study of Qinggan Jieyu granula in the treatment of primary insomnia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037297
Enrollment
Unknown
Registered
2020-08-27
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Primary insomnia

Interventions

Sponsors

Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Between 35-65 age, no gender limit; 2. The diagnostic criteria of primary insomina refer to International Classification of sleep disorders (3rd Edition) edited by American Sleep Medicine Association; 3. The diagnostic standard of Fire derived from Stagnation of Liver-QI Type refer to Guidelines for the Clinical Research of Chinese Medicine New Drugs; 4. Volunteer to participate in the research and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Combined with severe heart, liver, lung, kidney and other physical diseases and cancer patients; 3. Sleep disorders caused by nervous system diseases and psychosis; 4. Insomnia caused by drugs or alcohol; 5. alcoholics and drug addicts.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index, PSQI;

Secondary

MeasureTime frame
SPIEGEL Questionnaires;HAMA;HAMD;SF-36;TCM symptom scale;

Countries

China

Contacts

Public ContactYan Han

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

hanyan9007@163.com+86 18116083028

Outcome results

None listed

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