Skip to content

Efficacy evaluation and mechanism of Ditan Qingnao formula in the treatment of negative symptoms of schizophrenia

Efficacy evaluation and mechanism of Ditan Qingnao formula in the treatment of negative symptoms of schizophrenia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075768
Enrollment
Unknown
Registered
2023-09-14
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

schizophrenia

Interventions

Ditan Qingnao formula:Currently stable antipsychotic drug treatment plan+Ditan Qingnao Formula granules
Placebo:Currently stable antipsychotic drug treatment plan+traditional Chinese medicine granules placebo

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: ? Age=65 years old and = 18 years old; ? Stable vital signs, clear consciousness, and certain expressive ability; ? Having sufficient audio-visual skills to complete the necessary examinations for research; ? Conforming to the diagnostic criteria of phlegm dampness internal obstruction syndrome in traditional Chinese medicine for epilepsy; ? Meets the diagnostic criteria for ICD-11 schizophrenia and currently has stable positive symptoms; ? Currently, taking antipsychotic drugs is the second-generation antipsychotic drug; ? At present, the antipsychotic medication regimen is stable and the equivalent daily dose of antipsychotic drugs is between 5-20mg; ? The patient and their guardian agree and sign an informed consent form. Only those who meet the above eight criteria can be selected.

Exclusion criteria

Exclusion criteria: ? Individuals with unstable vital signs and those with major diseases, such as malignant tumors, severe aplastic anemia, etc; ? Individuals with known drug allergies; ? Schizophrenic patients with tension type, mental development delay, brain organic and physical disorders caused by mental disorders; ? Individuals with a history of electric shock, chronic physical disease, severe gastrointestinal disease, and abuse of psychoactive substances; ? Pregnant or lactating women; ? Have a recent history of infection. Those who meet one of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
positive and negative symptom scale,PANSS;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Score;schizophrenia quality of life scale,SQLS;interleukin-6,IL-6;interleukin-1ß,IL-1ß;Tumour necrosis factor-a,TNF-a;

Countries

CHINA

Contacts

Public ContactSun Wenjun

The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine

doctorsunwenjun@126.com+86 189 1025 9376

Outcome results

None listed

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