Skip to content

Effect of Tongren niuhuang qingxin pills in the treatment of generalized anxiety disorder (Phlegm and heat disturbing the heart) with insomnia: a randomized clinical trial

Effect of Tongren niuhuang qingxin pills in the treatment of generalized anxiety disorder (Phlegm and heat disturbing the heart) with insomnia: a randomized clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078444
Enrollment
Unknown
Registered
2023-12-08
Start date
2023-12-08
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

generalized anxiety disorder with insomnia

Interventions

treatment group:Tongren niuhuang qingxin pills
control group:Lorazepam Tablets

Sponsors

The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) The age ranged from 18 to 65 years. (2) Patients with generalized anxiety who conformed to the criteria for a clinical study. (3) Meet the Traditional Chinese Medicine (TCM) syndromes of Phlegm and heat disturbing the heart. (4) Meet the diagnostic criteria for insomnia. (5) Vital signs are stable, clear mind and expressive ability. (6) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1)Physical illness secondary to generalized anxiety disorder, such as coronary heart disease, cerebrovascular disease, hypertension, diabetes, thyroid disease, etc. (2)Patients with unstable vital signs. (3)Severe aphasia, agnosia and inability to communicate. (4)Anxiety associated with other mental disorders (like depression, obsessive-compulsive disorder, schizophrenia) clinically diagnosed by western medicine. (5)People who suffer from insomnia due to drug abuse or excessive alcohol consumption, coffee, strong tea, and adverse life factors. (6)People with known alcohol or drug dependence. (7)Patients clinically diagnosed with non-anxiety psychosis by western medicine. (8)Other traditional Chinese medicines or therapy for anxiety and insomnia were also used during the study. (9)Not taking medications as prescribed, unable to determine efficacy, and incomplete data affect the efficacy or safety. (10)Those who refused to take medication and had committed suicide. (11)Patients who had received anti-anxiety treatment within 1 week before the test. (12)Severe hepatic and renal insufficiency. (13)Pregnant and lactating women. (14)Patients who met other syndrome criteria.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale;Pittsburgh sleep quality Index;Traditional Chinese Medicine Syndrome Score;Determination of inflammatory cytokines in serum specimens;Determination of neurotransmitter in serum specimens;

Secondary

MeasureTime frame
Short form 36 questionnaire;Stroop color and word test;

Countries

CHINA

Contacts

Public ContactQu Miao

The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine

ivy_miao@163.com+86 133 6611 8030

Outcome results

None listed

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