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A randomized, double-blind, placebo-controlled study of Jieyu Xifeng Decoction in the treatment of anxiety insomnia

A randomized, double-blind, placebo-controlled study of Jieyu Xifeng Decoction in the treatment of anxiety insomnia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037366
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-12-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

Insomnia comorbid anxiety disorder

Interventions

Sponsors

Shanghai Hospital of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria of Western medicine for insomnia; 2. According to the TCM diagnostic criteria of insomnia; 3. The age is 18-70 years old; 4. PSQI score > 11, Spiegel Sleep Scale (improved) score > 12,HAMA score >= 14, and HAMA < 30; 5. No traditional Chinese medicine or western medicine was used to treat insomnia symptoms in the past month, or other drugs were taken in a short time (1 week), but no effect was found; 6. Those who voluntarily participate in this clinical study, are willing to receive treatment in accordance with the prescribed course of treatment, and can sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with depression, severe anxiety, bipolar disorder, schizophrenia, aphasia and other serious, neuropsychiatric diseases, accompanied by thyroid function, hypertension, coronary heart disease and with serious heart, liver, kidney or other serious organic damage disease; 2. Pregnant and lactating women; 3. Subjects taking sleeping pills, antidepressants, etc.; 4. Those who fail to treat according to the specified requirements, and fill in incomplete information, etc. can not accurately judge the curative effect.

Design outcomes

Primary

MeasureTime frame
PSQI score;HAMA score;

Countries

China

Contacts

Public ContactZhang wenjing

Shanghai Hospital of Traditional Chinese Medicine

carrie1072@sina.com+86 18616360246

Outcome results

None listed

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