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Randomized, double-blind, controlled study of Shizhen’anshen granules therapy for individuals at high risk of schizophrenia

Randomized, double-blind, controlled study of Shizhen’anshen granules therapy for individuals at high risk of schizophrenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013513
Enrollment
Unknown
Registered
2017-11-23
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-11-27

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

Conditions

Schizophrenia

Interventions

Group treated with Chinese herb:Take Shizhenanshen granules and aripiprazole placebo
Control group:Take aripiprazole and Shizhen'anshen placebo

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. meet the criteria for the study of schizophrenia, high-risk groups standards; 2. Aged between 18 and 30 years (including 18 and 30); 3. Sign the informed consent and be able to comply with the research scheme; 4. Understand the follow-up questionnaire survey; 5. Meet the criteria of the standard of traditional Chinese medicine syndromes of hyperactivity of fire due to deficiency of kidney yin (hallucinations, delusions, weird thinking, thinking lax, looseness of thought, stunned and speechless, automatic speaking and laughing, solitude, soreness and weakness of waist and knees, dry mouth, constipation, red tongue, Thin tongue coating with teeth marks, fine rapid stringlike pulse)

Exclusion criteria

Exclusion criteria: 1. Have severe suicidal tendencies; 2. Be in a depressive episode; 3. With serious or unstable heart, liver, kidney, endocrine, blood and other medical diseases; 4. Be treated with antipsychotic medications within 4 weeks; 5. Unattended or unable to take medicine as directed by doctor; 6. Compared to baseline, the reduction rate of ultra-high-risk of schizophrenia structured interview scale screening score is more than 25%; 7. Meets diagnostic criteria of other mental disorders.

Design outcomes

Primary

MeasureTime frame
symptoms assessment;assessment of cognition function;assessment of adverse reaction;

Countries

China

Contacts

Public ContactJia Hongxiao

Beijing Anding Hospital, Capital Medical University

jhxlj@vip.163.com+86 010 58303065

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026