Based on the theory of blood deficiency and liver fever, the efficacy of randomized double-blind placebo-controlled treatment of chronic anxiety insomnia was discussed

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080031

Enrollment

Unknown

Registered

2024-01-18

Start date

2023-07-24

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Anxiety insomnia

Interventions

Ningxin Anshen Fang group :Ningxin Anshen Fang

placebo group:placebo.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for DSM-V insomnia disorder; (2) Age 18-60 years old, male or female; (3) The course of the disease = 3 months, and no sedative sleeping drugs and anti-anxiety drugs have been taken within 4 weeks; (4) Pittsburgh's Sleep Quality Index (PSQI) score= 11 points; (5) Hamilton Anxiety Scale (HAMA) total score = 7, <24 points: mild to moderate anxiety; (6) The patient agrees to receive the treatment method of this study and signs the informed consent form. Only subjects who meet the above 6 items can be included in this study.

Exclusion criteria

Exclusion criteria: (1) Depression, bipolar disorder, schizophrenia, cognitive impairment and other serious neuropsychiatric diseases; (2) Pregnant or lactating women, allergic constitution and allergic to this drug; (3) Anxiety and insomnia caused by physical diseases such as hyperthyroidism, hypertension, coronary heart disease or other mental diseases; (4) Are taking sleeping pills, antidepressants, etc., excluding stimulants, hypnotic sedative drugs or anxiolytics Insomnia caused by withdrawal reactions; (5) Those with serious heart, liver, kidney or other systemic diseases; Those who participate in other clinical trials at the same time; (6) Those who are unable to sign the informed consent form. Subjects who meet any of the above criteria may be excluded.

Design outcomes

Primary

Measure	Time frame
Pittsburgh sleep quality index;Hamilton Anxiety Scale;Brain-derived Neurotrophic Factor;Glial Cell Line-Derived Neurotrophic Factor;	—

Secondary

Measure	Time frame
TCM Syndrome Scale;Insomnia Severity Index;Antioxidant index;Oxidation index;	—

Countries

China

Contacts

Public ContactHang Xiong

Dongzhimen Hospital, Beijing University of Chinese Medicine

xionghang2004@sina.com+86 10 8081 6655

Outcome results

None listed

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