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A randomized controlled study on the effects of variable doses of Tianmeng oral solution on serum prolactin, oxytocin, blood lipids, and cytokines in schizophrenia patients taking atypical antipsychotics

A randomized controlled study on the effects of variable doses of Tianmeng oral solution on serum prolactin, oxytocin, blood lipids, and cytokines in schizophrenia patients taking atypical antipsychotics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000918
Enrollment
Unknown
Registered
2026-04-09
Start date
2025-10-25
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Schizophrenia

Interventions

Control group:In the first month, maintenance treatment with atypical antipsychotics plus 10ml of Sweet Dream oral liquid twice daily
in the second month, maintenance treatment with atypical antipsychotics
Experimental Group One:In the first month, atypical antipsychotics were maintained along with 20ml of Tianmeng oral liquid twice daily
in the second month, atypical antipsychotics were maintained.
Experimental Group 2:In the first month, maintenance treatment with atypical antipsychotic drugs plus 20ml of Tianmeng oral liquid orally twice a day
in the second month, maintenance treatment with atypical antipsychotic drugs plus 10ml of Tianmeng oral liquid orally twice a day

Sponsors

Qujing Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged 18-60 who meet the ICD-10 criteria for schizophrenia; 2) PANSS total score =60; 3) Receiving atypical antipsychotic maintenance treatment at therapeutic doses for =12 weeks; and have not used drugs affecting the endocrine system, such as prednisone; 4) Subjects must have a certain level of comprehension, be able to communicate effectively with researchers, and complete study-related assessments; 5) Patient's family members must sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Does not meet the inclusion criteria; (2) Those with a family history of obesity; (3) Renal failure, thyroid dysfunction, ovarian lesions, pituitary tumours; (4) Those with a history of psychoactive drug dependence; (5) Positive urine drug screen, history of alcohol or drug abuse or dependence within the past year; (6) Patients who have used Sweet Dream oral solution without effect in the two months prior to assessment; (7) Patients with mental disorders caused by organic somatic diseases; (8) Uncooperative, unable to communicate, or deemed unsuitable for participation by the researcher; (9) Abnormal liver function indicators (1.5 times higher than the normal value)

Design outcomes

Primary

MeasureTime frame
Serum prolactin;

Secondary

MeasureTime frame
Oxytocin;Brain-derived neurotrophic factor;Blood lipids;Liver function;Cognitive Function Scale;

Countries

China

Contacts

Public ContactGao Fei

Qujing Third People's Hospital

1686793433@qq.com13988900016

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026